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PubMed1999

Antiemetic efficacy of granisetron: a randomized crossover study in patients receiving cisplatin-containing intraarterial chemotherapy.

BACKGROUND: Cisplatin (CDDP) is one of the most active chemotherapeutic agents but is among the most emetogenic drugs. The emetic side-effects of CDDP-containing intraarterial chemotherapy have not been evaluated in a prospective randomized trial and the efficacy of serotonin antagonists in preventing the emesis associated with this method of CDDP administration has not been assessed. METHODS: CDDP 50 mg/m2 and methotrexate 30 mg/m2 were administered every 3 weeks through intraarterial catheters placed in the bilateral internal iliac arteries. Patients were classified into two groups: granisetron treatment group (group G) and no treatment group (group NG) with the first course of chemotherapy, crossing over with the second course. The patients in group G received granisetron 40 micrograms/kg by intravenous infusion. RESULTS: Although intraarterial CDDP administration produced less emesis than intravenous CDDP administration, at the same concentration, gastrointestinal toxicity is still the most unpleasant side-effect for patients. Granisetron administration significantly reduced nausea and vomiting during the acute emetic phase (an evaluation of treatment as very effective and effective was made in 89% in group G and 33% in group NG (P < 0.001). Complete control of emesis was achieved in 68 and 18% of patients in groups G and NG, respectively (P < 0.0001). CONCLUSION: A single prophylactic infusion of granisetron was effective in preventing the nausea and vomiting associated with intraarterial CDDP-containing therapy.

Adolescent↗
PubMed1996

A multicentre, double-blind study comparing placebo, ondansetron and ondansetron plus dexamethasone for the control of cisplatin-induced delayed emesis. Ondansetron Delayed Emesis Study Group.

BACKGROUND: The purpose of this study was to investigate the efficacy and safety of oral ondansetron, given alone or in combination with dexamethasone in the control of cisplatin-induced delayed emesis. PATIENTS AND METHODS: This was an international, multicentre, double-blind, randomised, placebo-controlled, parallel group study. A total of 640 chemotherapy-naïve patients received ondansetron 8 mg i.v. and dexamethasone 20 mg i.v. for the control of acute emesis prior to cisplatin (> or = 70 mg/m2) on day 1. Patients who were not rescued or withdrawn on day 1 were to be randomised 24 hours after the start of cisplatin administration to one of four groups; group I placebo oral (p.o.), twice daily (bd) on days 2-6 (n = 125); group II ondansetron (8 mg p.o. bd) on days 2/3 followed by placebo (p.o. bd) on days 4-6 (n = 199); group III ondansetron (8 mg p.o. bd) on days 2-6 (n = 214); group IV ondansetron (8 mg p.o. bd) plus dexamethasone (4 mg p.o. bd) on days 2-6 (n = 66). RESULTS: On day 1, 81% of patients had complete control of acute emesis, with 68% having no emesis and no nausea. Over days 2/3 and over days 2-6, significantly more patients receiving ondansetron plus dexamethasone (group IV) reported no emesis and no nausea (49% and 45%, respectively) compared to ondansetron alone (32% and 27%, respectively) or placebo (group I; 33% and 27%, respectively; P < 0.05 for all pairwise comparisons). There were no significant differences in the control of emesis over days 2/3, where 61% of patients had complete emetic control (0 emetic episodes) with ondansetron plus dexamethasone (group IV), 54% with ondansetron (groups II + III) and 49% with placebo (group I). In the distribution of nausea grades, ondansetron plus dexamethasone (group IV) was significantly superior to ondansetron (groups II + III); P = 0.037) and placebo (group I; P = 0.013) over days 2/3. Over days 2-6 there were no significant differences in the control of emesis, however a comparison of the distribution of nausea grades over days 2-6 showed ondansetron plus dexamethasone (group IV) to be significantly superior to ondansetron (group III; P = 0.043) and placebo (group I; P = 0.024). All treatments were well tolerated and no unexpected drug-related adverse events were reported. There were no differences in the overall incidence of adverse events between the active treatment groups or placebo. Constipation and headache, recognised side effects of 5-HT3 receptor antagonists, were the most commonly reported adverse events with the incidence of constipation with ondansetron alone (group III) being significantly greater than with over days 2-6 (14% vs. 6%; P = 0.030). CONCLUSION: In contrast to some previous investigations, in this study, ondansetron alone appears to have a minor role in the control of cisplatin-induced delayed emesis and nausea. In conclusion, the combination of oral ondansetron plus dexamethasone is superior to ondansetron and to placebo.

Adult↗
PubMed1985

A cross-over comparison of nabilone and prochlorperazine for emesis induced by cancer chemotherapy.

An anti-emetic drug, nabilone, a synthetic cannabinoid, has been compared with prochlorperazine in 24 lung cancer patients receiving cancer chemotherapy. Each of the drugs studied was given orally every 12 hours, starting the night before chemotherapy, during one of two consecutive identical chemotherapy cycles in accordance with a double-blind cross-over random order assignment. Single doses were 2 mg of nabilone, or 15 mg of prochlorperazine. The chemotherapeutic regimens given included the following drugs in various combinations: cis-platinum, vincristine, cyclophosphamide, adriamycin, vindesine, and etoposide (VP16). Nabilone was significantly superior to prochlorperazine in the reduction of vomiting episodes. Side effects, mainly vertigo, were evident in nearly half of the patients after nabilone, and three patients were withdrawn from the study due to decreased coordination and hallucinations after nabilone. Side effects from prochlorperazine were limited to mild drowsiness in one patient. Two-thirds of the patients preferred nabilone to prochlorperazine. We conclude that nabilone is a moderately effective anti-emetic drug, but that the unpredictability of its side effects call for careful patient information, especially with elderly outpatients. We recommend that at least after the first dose of nabilone, the patient should be kept under close observation during 4 hours.

Administration, Oral↗
PubMed1993

Phase II trial of a single intravenous dose of ondansetron in patients receiving cisplatin > or = 100 mg/m2.

Ondansteron, a serotonin antagonist antiemetic, controls emesis caused by cisplatin when given as multiple 0.15 mg/kg dosages in a variety of administration schedules. This trial evaluated a single 0.45 mg/kg i.v. dose of ondansetron in 21 cancer patients receiving cisplatin at doses > or = 100 mg/m2 as initial chemotherapy. Twenty-five percent of patients had no emetic episodes (95% confidence interval: 9-49%), and 45% had two or fewer emetic episodes (95% confidence interval: 23-69%). No significant adverse effects were seen. In prior trials at this institution in similarly treated patients, ondansetron given in three divided doses yielded a 42% no emesis rate. In this trial a single i.v. 0.45 mg/kg dose of ondansetron prevented emesis in 25% of patients receiving initial cisplatin > or = 100 mg/m2. For this dose of cisplatin and ondansetron, the observed emesis complete control rate was lower than that previously seen using multiple dose schedules.

Adult↗
PubMed1996

Antiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy.

This randomized, double-blind, parallel-group, multicenter study compared the antiemetic effectiveness, safety, and tolerability of two different intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/kg) in cancer patients receiving their first course of high-dose cisplatin-containing chemotherapy (> or = 75 mg/m2). Efficacy was assessed by recording the timing, number, and severity of emetic episodes in the 24 h following high-dose cisplatin. Safety was evaluated by monitoring adverse events, vital signs, clinical laboratory parameters, and electrocardiograms. Of the 62 patients enrolled in the study, 29 received 0.6 mg/kg of dolasetron mesylate and 33 received 1.8 mg/kg. Patients who received dolasetron mesylate 1.8 mg/kg consistently experienced a greater degree of antiemetic control than those who received 0.6 mg/kg. Complete responses were achieved by 55% of patients who received 1.8 mg/kg compared with 31% for the 0.6-mg/kg group. The 1.8-mg/kg group achieved a significantly (p = 0.039) higher complete/ major response rate than the 0.6-mg/kg group (77% vs 55%, respectively) and a significantly (p = 0.004) longer time to the first emetic episode (> 24 h vs 13.5 h, respectively). More than 80% of patients were either satisfied or very satisfied with dolasetron treatment. The most common adverse events were mild to moderate in intensity, consistent with other studies, and included headache (24.1% of patients) and diarrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high-dose cisplatin for the first time and should be evaluated further in clinical trials.

Antiemetics↗
PubMed1997

A comparative study of intravenous granisetron versus intravenous and oral ondansetron in the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy.

We conducted a prospective, randomized, open, single-center, parallel group study comparing the anti-emetic efficacy and toxicity of granisetron with that of ondansetron in patients receiving moderately emetogenic chemotherapy. From December 1994 to May 1995, patients who were to receive moderately emetogenic chemotherapy for the first time or who had not received chemotherapy (80 to 100 mg/m2 of cisplatin or 40 mg/m2 of doxorubicin) within 4 weeks previously were enrolled in this study. The following anti-emetic regimens were used: 3 mg of granisetron were given intravenously before chemotherapy for a single dose; 8 mg of ondansetron were given intravenously before chemotherapy and then every 8 hours for a total of 3 doses, plus 8 mg of an oral maintenance dose every 12 hours for 5 consecutive days. We evaluated 97 patients (48 received granisetron and 49 received ondansetron). In the first 24 hours after chemotherapy, complete and major responses were achieved in 76.6% of the patients receiving granisetron and in 72.9% of patients receiving ondansetron (p = 0.9033). Additionally, there was no difference in the control of delayed nausea and vomiting between the two groups (51.1% versus 54.2%, p = 0.9200), and there were no significant adverse effects or toxicities. We have concluded that a single dose of granisetron is as effective in prophylaxis of emesis induced by moderately emetogenic chemotherapy as a triple dose of ondansetron plus oral maintenance.

Administration, Oral↗
PubMed1995

Recovery and complications after tonsillectomy in children: a comparison of ketorolac and morphine.

Ninety-six children received morphine 0.1 mg/kg (n = 47) or ketorolac 1 mg/kg (n = 49) intravenously (IV) in a prospective, randomized, double-blind fashion, after tonsillectomy. Recovery variables and complications were recorded while subjects were in the hospital and parent(s) were contacted 24 h and 14 days after surgery. There were no differences in demographics, surgical management, awakening time, oxygen requirements, or time to readiness for postanesthesia care unit (PACU) discharge or discharge home between the two groups. Ketorolac subjects had fewer emetic episodes than morphine subjects (median 1 vs 3; P = 0.006) and were less likely to have more than two episodes of emesis after PACU discharge (9/49 vs 22/47; P = 0.007). Ketorolac subjects had more major bleeding (bleeding requiring intervention; 5/49 vs 0/47, one-tailed P = 0.03) and more bleeding episodes (0.22 episodes/subject vs 0.04 episodes/subject, P < 0.05) in the first 24 h after surgery, but no greater overall incidence of bleeding than the morphine subjects. In children having tonsillectomy, ketorolac, compared to morphine, reduced the number of emetic episodes after PACU discharge, but did not hasten awakening, readiness for PACU discharge or discharge home, and increased the likelihood of major bleeding in the first 24 h after surgery.

Analgesics, Non-Narcotic↗
PubMed1996

Intraoperative antiemetic efficacy of prophylactic ondansetron versus droperidol for cesarean section patients under epidural anesthesia.

The efficacy of ondansetron and droperidol were evaluated for prophylactic treatment of nausea and vomiting in cesarean section patients under epidural anesthesia. Forty-eight ASA physical status I-II parturients requiring nonemergent cesarean section gave their consent and were randomly assigned into one of three treatment groups (n = 16 each) according to a double-blind, placebo-controlled protocol. When the fetal umbilical cord was clamped, patients received intravenously 8 mg of ondansetron or 0.625 mg of droperidol or saline depending on their treatment group. Ninety-four percent of the ondansetron group, 88% of the droperidol group, and 56% of the placebo group were emesis free. Sixty-nine percent of the ondansetron group, 75% of the droperidol group, and 31% of the placebo group were nausea free. This study showed a significantly lower incidence of nausea and vomiting and a tendency toward less severe emetic symptoms in the ondansetron and the droperidol groups than in the placebo group, but the ondansetron group was not statistically different from the droperidol group. This study is the first to report the antiemetic efficacy of prophylactic ondansetron in cesarean section patients or in patients under epidural anesthesia for abdominal surgery. Both prophylactic ondansetron and droperidol were similarly effective, and significantly better than placebo, in reducing the incidence and severity of intraoperative emetic symptoms in cesarean section patients under epidural anesthesia.

Adult↗
PubMed1997

Intravenous dolasetron for the prevention of postoperative nausea and vomiting after outpatient laparoscopic gynecologic surgery.

The newer 5-hydroxytryptamine type 3 (5-HT3) antagonists are sometimes considered for routine prophylaxis of postoperative nausea and vomiting (PONV) in high-risk patients. This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and safety of three single intravenous (IV) doses of dolasetron mesylate salt (12.5, 25, or 50 mg) for the prevention of PONV in 635 females undergoing outpatient laparoscopic gynecologic surgery. Antiemetic efficacy was evaluated over a 24-h postoperative period by recording the number and timing of emetic episodes; effects on nausea were evaluated by a visual analog scale (VAS). The proportion of complete responders (no emetic episodes and no escape medication in 24 h) was significantly higher with each dolasetron mesylate dose (> 50% for each dose; P < or = 0.0003) than with placebo (30.6%). Fewer patients given dolasetron required or requested escape antiemetic medication compared with placebo (P < 0.0003). Dolasetron-treated patients had significantly (P < 0.0357) lower median postdose maximum nausea VAS scores compared with placebo-treated patients. Patient satisfaction with dolasetron was high and, overall, was significantly (P = 0.0131) greater than that with placebo. Dolasetron was an effective and well tolerated preventive treatment for PONV resulting from laparoscopic gynecologic surgery.

Adult↗
PubMed1997

Comparison of tropisetron, droperidol, and saline in the prevention of postoperative nausea and vomiting after gynecologic surgery.

This study was performed to compare the efficacy of tropisetron, droperidol, and saline in the prevention of postoperative nausea and vomiting (PONV) and to compare the possible adverse effects of these drugs in gynecologic incontinence surgery. Using a randomized, double-blind study design, we studied 150 women undergoing gynecologic incontinence surgery with standardized general anesthesia. At the end of surgery, the patients received either tropisetron 5 mg, droperidol 1.25 mg, or 0.9% saline intravenously (i.v.). As a rescue antiemetic, the patients received metoclopramide 10 mg i.v.. The episodes of nausea, retching, and vomiting; the need for rescue treatment; and the type and severity of adverse events were recorded at four occasions during the 48-h observation period. Pain, anxiety, drowsiness, and general satisfaction were also evaluated on a linear numerical scale of 0-10. Complete response (no PONV within the 48-h observation period) occurred similarly in the study groups (tropisetron 25%, droperidol 22%, and placebo 18%). Tropisetron and droperidol had no effect on the incidence of nausea and retching. However, the incidence of vomiting was significantly less in the tropisetron group than in the placebo group (tropisetron 19%, droperidol 45%, and placebo 57%). The number of emetic episodes (retching and/or vomiting) per patient within 48 h was significantly decreased under tropisetron when compared with placebo (tropisetron 2.5 +/- 3.4, droperidol 4.2 +/- 6.1, placebo 5.9 +/- 7.1). With regard to adverse events, the patients in the droperidol group had significantly more anxiety than the placebo group (2-6 h postoperatively), more drowsiness than the tropisetron and placebo groups (0-2 h postoperatively), and more dissatisfaction than the tropisetron (0-6 h postoperatively) and placebo groups (2-6 h postoperatively). We conclude that tropisetron given 5 mg i.v. during anesthesia in gynecologic incontinence surgery effectively prevents vomiting but not nausea and retching, while 1.25 mg i.v. droperidol fails to prevent any of these emetic symptoms and results in adverse events.

Antiemetics↗
PubMed1997

Intravenous ondansetron for postsurgical opioid-induced nausea and vomiting. S3A-255 Study Group.

The use of opioids for postoperative analgesia may be limited by side effects such as nausea and vomiting. Because ondansetron, a selective serotonin type 3 (5-hydroxytryptamine [5-HT3]) antagonist, is effective for chemotherapy and general anesthesia-induced nausea and vomiting, we hypothesized that it may also be effective for opioid-induced nausea and vomiting. ASA physical status I-III patients undergoing regional anesthesia were eligible for the study. Those who requested an antiemetic after postsurgical opioid administration were randomized to receive a single dose of ondansetron (0.1 mg, 4 mg, or 16 mg intravenously [I.V.]) or placebo in a double-blind fashion. Emetic episodes, nausea and pain ratings, and adverse events were recorded for 24 h after study drug administration. Patient satisfaction scores were obtained 24 h after study drug infusion. A significantly (P < 0.05) larger proportion of patients treated with ondansetron 4 mg and 16 mg experienced no emetic episodes, received no rescue antiemetic, and completed the study compared with placebo. Nausea scores and patient satisfaction scores in the ondansetron 16-mg group were significantly (P < 0.05) more favorable than in the placebo group. Postsurgical pain scores did not differ among groups. The incidence of adverse events was similarly low across groups. The results of this study support our hypothesis that I.V. ondansetron is effective for postsurgical opioid-induced nausea and vomiting.

Adult↗
PubMed1997

Treatment of postoperative nausea and vomiting with single intravenous doses of dolasetron mesylate: a multicenter trial. Dolasetron Mesylate PONV Treatment Study Group.

UNLABELLED: This study was conducted to determine the efficacy and safety of four intravenous (I.V.) doses of dolasetron, an investigational 5-HT3 receptor antagonist, for the treatment of postoperative nausea and/or vomiting (PONV) after outpatient surgery under general anesthesia. This multicenter, randomized, double-blind trial compared the antiemetic efficacy of 12.5, 25, 50, or 100 mg I.V. dolasetron with placebo over 24 h using complete response (no emetic episodes and no rescue medication), time to first emetic episode or rescue medication, and patient nausea and satisfaction with antiemetic therapy as rated by visual analog scale (VAS). Of 1557 patients enrolled, 620 patients were eligible for treatment. Complete response rates for all dolasetron doses--12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)--were significantly more effective than placebo (11%, P < 0.05). There was a significant gender interaction for complete response (P < 0.01). Of the patients in the 25-mg and 100-mg dose groups, 12% and 13%, respectively, experienced no nausea (VAS score < 5 mm) versus 5% in the placebo group (P < 0.05). There were no clinically relevant changes in vital signs or laboratory values and no trends with dose for adverse events. Dolasetron is effective for treating PONV and has an adverse event profile similar to that of placebo. The 12.5-mg dose was as effective as larger doses for complete response. IMPLICATIONS: Nausea and vomiting are common problems for postsurgical patients. In this study of 620 patients undergoing surgery, a 12.5-mg dose of intravenous dolasetron, a new serotonin-receptor blocker, was significantly more effective than placebo in treating established postoperative nausea and vomiting. Dolasetron 12.5 mg was as safe as placebo.

Adult↗
PubMed1998

Factors affecting discharge time in adult outpatients.

UNLABELLED: Discharge time (total recovery time) is one determinant of the overall cost of outpatient surgery. We performed this study to determine what factors affect discharge time. Details regarding patients, anesthesia, surgery, and recovery were recorded prospectively for 1088 adult patients undergoing ambulatory surgery over an 8-mo period. The contribution of factors to variability in the discharge time was assessed by using multivariate linear regression analysis. In the last 4 mo of the study, nurses indicated the causes of discharge delays > or =50 min in Phase 1 or > or =70 min in Phase 2 recovery. When all anesthetic techniques were included, anesthetic technique was the most important determinant of discharge time (R2 = 0.10-0.15; P = 0.001), followed by the Phase 2 nurse. After general anesthesia, the Phase 2 nurse was the most important factor (R2 = 0.13; P = 0.01-0.001). In women, the choice of general anesthetic drugs was significant (R2 = 0.04; P = 0.002). The three most common medical causes of delay were pain, drowsiness, and nausea/vomiting. System factors were the foremost cause of Phase 2 delays (41%), with lack of immediate availability of an escort accounting for 53% of system-related delays. We conclude that efforts to shorten discharge time would best be directed at improving nursing efficiency; ensuring availability of an escort for the patient; and preventing postoperative pain, drowsiness, and emetic symptoms. The selection of anesthetic technique and anesthetic drug seems to be of selective importance in determining discharge time depending on patient gender and type of surgery. IMPLICATIONS: The relative importance of anesthetic and nonanesthetic factors were evaluated as determinants of discharge time after ambulatory surgery. Postoperative nursing care was the single most important factor after general anesthesia; anesthetic drugs, anesthetic technique, and prevention of pain and emetic symptoms were of selective importance depending on patient gender and type of surgery.

Adolescent↗
PubMed1999

Granisetron/dexamethasone combination for reducing nausea and vomiting during and after spinal anesthesia for cesarean section.

UNLABELLED: We compared the efficacy of granisetron plus dexamethasone with that of granisetron alone for preventing nausea and vomiting in parturients undergoing cesarean section under spinal anesthesia. In a randomized, double-blinded manner, 120 patients received either granisetron 3 mg (Group I, n = 60) or granisetron 3 mg plus dexamethasone 8 mg (Group II, n = 60) IV immediately after clamping of the fetal umbilical cord. A complete response, defined as no emetic symptoms and no need for another rescue antiemetic medication in the intraoperative, postdelivery period was 83% in Group I and 98% in Group II (P = 0.008); the corresponding rates during the first 24 h after surgery was 85% and 98% (P = 0.016). No clinically serious adverse events were observed in any of the groups. In conclusion, the prophylactic use of a granisetron/dexamethasone combination is more effective than granisetron alone for reducing nausea and vomiting in patients during and after spinal anesthesia for cesarean section. IMPLICATIONS: Intraoperative, postdelivery, and postoperative nausea and vomiting are distressing to patients undergoing cesarean section under spinal anesthesia. The combination of granisetron plus dexamethasone was evaluated and found to be effective for preventing these emetic symptoms.

Adult↗
PubMed2000

A comparison of the costs and efficacy of ondansetron versus dolasetron for antiemetic prophylaxis.

UNLABELLED: The optimal dose and timing of 5-HT(3) antagonist administration for prophylaxis against postoperative nausea and vomiting (PONV) remains controversial. Although 5-HT(3) antagonists seem to be most effective when administered near the end of surgery, there are no data on the comparative efficacy or costs associated with the 5-HT(3) antagonists dolasetron and ondansetron when administered at the end of the operation. In this double-blinded study, 200 outpatients undergoing otolaryngologic procedures with a standardized general anesthetic received 4 (O4) or 8 mg (O8) of ondansetron or 12.5 (D12.5) or 25 mg (D25) of dolasetron IV within 30 min before the end of surgery. A blinded observer recorded the emetic episodes, maximum nausea score, recovery room resource and drug use, nursing time spent managing PONV, times to achieve discharge criteria from the Phase 1 and 2 recovery units, postdischarge emesis, and patient satisfaction. Total costs were calculated by using the perspective of a free-standing surgicenter. There were no differences in patient demographics, incidence of PONV, need for rescue medications, time spent in the recovery areas, unanticipated hospital admissions, or patient satisfaction among the four treatment groups. The mean total costs (95% confidence intervals) to prevent PONV in one patient were lowest in the D12.5 group: $23.89 (17.18-28.79) vs $37.81 (30.29-45.32), $33.91 (28.92-39.35), and $75.18 (61.13-89.24) for D25, O4, and O8, respectively. Excluding nursing labor costs did not alter this finding: $18.51 (14.18-22.85), $34.77 (28.03-41.49), $31.77 (28. 92-39.35), and $71.76 (58.17-85.35) for D12.5, D25, O4, and O8, respectively. We conclude that 12.5 mg of dolasetron IV is more cost effective than 4 mg of ondansetron IV for preventing PONV after otolaryngologic surgery and is associated with similar patient satisfaction. IMPLICATIONS: When administered at the end of surgery, 12.5 mg of dolasetron IV is as effective as 25 mg of dolasetron IV, 4 mg of ondansetron IV, and 8 mg of ondansetron IV in preventing emetic symptoms after otolaryngologic surgery and was associated with similar patient satisfaction at a reduced cost. There were no differences in the antiemetic efficacy of the 4 and 8 mg doses of ondansetron.

Ambulatory Surgical Procedures↗
PubMed2000

Substance P (Neurokinin-1) antagonist prevents postoperative vomiting after abdominal hysterectomy procedures.

BACKGROUND: The safety and antiemetic efficacy of CP-122,721, a novel neurokinin-1 antagonist, was evaluated when administered alone or in combination with ondansetron. METHODS: Using a randomized, double-blind, placebo-controlled study design, CP-122,721 was initially compared with placebo and subsequently to ondansetron alone and in combination for prophylaxis against postoperative nausea and vomiting in 243 women undergoing abdominal hysterectomy. In the dose-ranging studies (n = 86), patients received either CP-122,721 100 mg (vs. placebo) or 200 mg (vs. placebo) orally 60-90 min before induction of anesthesia. In the interaction study (n = 157), patients received CP-122,721 200 mg or placebo 60-90 min before induction of anesthesia, and ondansetron 4 mg or saline 2 ml intravenously 15-30 min before the end of surgery. Patients assessed their level of nausea and pain on arrival in the postanesthesia care unit and at 0.5-, 1-, 1.5-, 2-, 4-, 8-, 12-, and 24-h intervals postoperatively. Emetic episodes, need for rescue antiemetic-antinausea medication, postoperative complications, and patient satisfaction were recorded. RESULTS: In the initial dose-ranging study, only 10% of the patients experienced emesis within the first 8 h after surgery with CP-122,721 200 mg compared with 50% in the placebo group. CP-122,721 200 mg also decreased the need for rescue medication (25% vs. 48%). CP-122,721 100 mg was less effective than 200 mg in decreasing the incidence of repeated episodes of emesis. In the interaction study, 6% of the patients receiving CP-122,721 200 mg orally experienced emesis less than 2 h after surgery compared with 17% with ondansetron alone. With combined therapy, only 2% experienced emesis. In addition, the median times for 75% of patients to remain free from postoperative nausea and vomiting were 82, 75, and 362 min in the ondansetron, CP-122,721, and combination groups, respectively. CONCLUSIONS: Oral CP-122,721 200 mg decreased emetic episodes compared with ondansetron (4 mg intravenously) during the first 24 h after gynecologic surgery; however, there was no difference in patient satisfaction.

Administration, Oral↗
PubMed2002

Comparison of acustimulation and ondansetron for the treatment of established postoperative nausea and vomiting.

BACKGROUND: This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand compared with ondansetron for the treatment of established postoperative nausea and vomiting (PONV) after outpatient laparoscopic surgery. METHODS: After the authors obtained institutional review board approval and written informed consent, 268 outpatients were enrolled in this randomized, double-blind, placebo- and sham-controlled study. All patients received antiemetic prophylaxis with metoclopramide, 10 mg intravenously, or droperidol, 0.625 mg intravenously, after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to one of three treatment groups: (1) the ondansetron group received 4 mg intravenous ondansetron and a sham ReliefBand; (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand; and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand. A rescue antiemetic (10 mg intravenous metoclopramide) was administered only if the PONV symptoms persisted for 15 min or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Postdischarge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 h after surgery. RESULTS: The combination group had a significantly higher complete response rate than the acustimulation group (73% vs.40%, P <0.01). In addition, fewer patients (8 vs. 18) in the combination (vs. acustimulation) group experienced subsequent emetic events (P < 0.03). However, there were no significant differences between the three groups with respect to patient satisfaction and quality of recovery scores. CONCLUSIONS: Acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV. However, the use of ondansetron (4 mg intravenously) in combination with the ReliefBand device improved the complete response rate to the acustimulation therapy.

Adult↗
PubMed2003

Difference in risk factors for postoperative nausea and vomiting.

BACKGROUND: It is commonly stated that risk factors for postoperative nausea are the same as for vomiting. The authors designed a prospective study to identify and differentiate the risk factors for postoperative nausea and vomiting in various surgical populations in a clinical audit setting. METHODS: The study included 671 consecutive surgical inpatients, aged 15 yr or more, undergoing various procedures. The study focused on postoperative nausea visual analog scale scores every 4 h and vomiting episodes within 72 h. Both vomiting and retching were considered as emetic events. Patient-, anesthesia-, and surgery-related variables that were considered to have a possible effect on the proportion of patients experiencing postoperative nausea and/or vomiting were examined. The bivariate Dale model for binary correlated outcomes was used to identify selectively the potential risk factors of postoperative nausea and vomiting. RESULTS: Among the 671 patients in the study, 126 (19%) reported one or more episodes of nausea, and 66 patients (10%) suffered one or more emetic episodes during the studied period. There was a highly significant association between the two outcomes. Some risk factors were predictive of both nausea and vomiting (female gender, nonsmoking status, and general anesthesia). History of migraine and type of surgery were mainly responsible for nausea but not for vomiting. The predictive effect of risk factors was controlled for postoperative pain and analgesic drugs. CONCLUSION: This study shows that differences exist in risk factors of postoperative nausea and vomiting. These could be explained by differences in the physiopathology of the two symptoms.

Adolescent↗