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PubMed1997

Intravenous dolasetron mesilate in the prevention of postoperative nausea and vomiting in females undergoing gynecological surgery.

STUDY OBJECTIVE: To evaluate a range of doses of intravenous (i.v.) dolasetron mesilate, in preventing postoperative nausea and vomiting (PONV). DESIGN: Double-blind, placebo-controlled, randomized, multicenter trial. SETTING: Ten hospitals and/or surgical centers. PATIENTS: 281 women undergoing gynecologic surgery with general anesthesia. INTERVENTIONS: Patients received one of four single, i.v. doses of dolasetron mesilate (12.5 mg, 25 mg, 50 mg, and 100 mg) or placebo administered following cessation of anesthesia. MEASUREMENTS AND MAIN RESULTS: Patients were monitored for 24 hours following study drug administration. The antiemetic efficacy of each dolasetron mesilate dose was evaluated by recording the number and timing of emetic episodes, and the effects on nausea were assessed by use of visual analog scales (VAS). Safety was assessed by adverse event reports, clinical laboratory tests, electrocardiographic (ECG) measurements, and monitoring vital signs. Complete responses (patients with no emetic episodes and no escape antiemetic medication requirements in 24 hours) were achieved by 54% in the 12.5-mg, 67% in the 25-mg, and 59% in both the 50-mg and 100-mg dolasetron mesilate dose groups, and by 43% in the placebo group. Nausea VAS assessments demonstrated that dolasetron-treated patients were significantly (p = 0.048) more likely to report no nausea (VAS score < 5 mm) than those in the placebo group. Adverse events reported generally were mild in intensity, and there were no clinically significant changes in laboratory tests, vital signs, or ECG parameters. CONCLUSIONS: Dolasetron was effective and well tolerated for the prevention of PONV in female patients undergoing gynecologic surgery with general anesthesia.

Adolescent↗
PubMed2006

Outcomes of octogenarians and nonagenarians in elective major gynecologic surgery.

OBJECTIVE: The purpose of this study was to determine whether age is a risk factor for perioperative and postoperative complications. STUDY DESIGN: This was a retrospective case-control study of 120 women over age 79 (group 1) compared with 1,497 younger patients 50-79 (group 2) undergoing major elective gynecologic surgery. RESULTS: Mean length of stay was 4.8 days for group 1, compared with 3.8 for group 2 (P = .018). Patients hospitalized longer than 1 week was higher (P < .01) among group 1. There were statistically significant increases in UTI, psychiatric events, pulmonary edema, respiratory failure, sepsis, and hypovolemic shock. No significant difference in mortality rate was noted (group 1: 0.83%, n = 1 vs group 2: 0.47%, n = 7). CONCLUSION: Although length of stay for the elderly is slightly increased, mortality and complication rates are comparable to younger patients with few exceptions. We conclude that age need not be the sole determinant in the decision to undergo major elective gynecologic surgery.

Aged↗
PubMed1996

[Combined spinal-epidural anesthesia for intra-abdominal gynecological surgeries].

Forty-five patients scheduled for intra-abdominal gynecological surgeries, ranging in age from 30 to 60 years, were anesthetized with combined spinal-epidural (CSE) method using combined spinal-epidural needles inserted at the L2-3 interspace. Ten minutes after intrathecal administration of 0.4% isobaric tetracaine solution (2.5 ml) the upper level of analgesia was examined by pin prick method and the patients were divided into the group A (N = 7; anesthetic level > or = Th7), B (N = 7; Th8-10) and C (N = 31; Th11-L1) according to their anesthetic levels. Target anesthetic level (Th4-7) was obtained in group B by peridural administration of 2% mepivacaine in a dose of 5 ml and the surgery was performed. However, in group C, mepivacaine 7 ml was insufficient to obtain the target anesthetic level and additional mepivacaine was necessary for the surgery. In group A, no mepivacaine was used in the first hour of the surgery. In all patients, except one in group C, in whom general anesthesia was used after insufficient segmental analgesia, anesthesia was maintained by the CSE technique. We concluded that adequate anesthetic level for the intra-abdominal surgery can be obtained by intrathecal isobaric tetracaine administration combined with peridural mepivacaine of a dose calculated according to the anesthetic level ten minutes after the spinal block.

Adult↗
PubMed2000

Low-dose intrathecal clonidine combined with sufentanil as analgesic drugs in abdominal gynecological surgery.

STUDY OBJECTIVES: To determine whether a low dose of spinal clonidine either alone or combined with sufentanil would provide effective analgesia following abdominal surgery, as a supplement to bupivacaine spinal anesthesia. DESIGN: Randomized double-blind study. SETTING: Gynecological surgery, teaching hospital. PATIENTS: 73 ASA physical status I and II patients undergoing gynecological abdominal surgery with spinal anesthesia. INTERVENTIONS: Patients were randomly assigned to one of four groups and prospectively studied to examine anesthesia, analgesia, and adverse effects. The control group received saline as the test drug; the sufentanil group received 10 microg of sufentanil; the clonidine group received 30 microg of clonidine; and the sufentanil/clonidine group received 5 microg of sufentanil plus 15 microg of clonidine. All groups received intrathecal 15 mg of bupivacaine (3 mL) plus the intrathecal test drug (2 mL). The concept of visual analog scale (VAS) was introduced. All patients were premedicated with intravenous midazolam. Rescue analgesics were available. MEASUREMENTS AND MAIN RESULTS: The groups were demographically the same. Sensory block to pinprick at 10 min was higher for clonidine and sufentanil/clonidine groups compared to the control group (p < 0.02). Anesthetic time (Bromage score 2) was also longer for clonidine and sufentanil/clonidine groups compared to the control and sufentanil groups (p < 0.05). Time to first rescue analgesics was shorter in the control group compared to the other groups (p < 0.02). The number of IM diclofenac dose injections in 24 hours was higher in the control group compared to all other groups (p < 0.05). The incidence of adverse effects and ephedrine consumption were similar among groups. CONCLUSIONS: Intrathecal 15- and 30-microg clonidine doses expanded the anesthesia sensory block and duration of motor block, and provided analgesia.

Abdomen↗
PubMed2003

Granisetron versus granisetron/dexamethasone combination for the treatment of nausea, retching, and vomiting after major gynecologic surgery: a randomized, double-blind study.

BACKGROUND: Granisetron, a selective 5-hydroxytryptamine3 antagonist, is effective for the treatment of patients with postoperative nausea and vomiting. Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. OBJECTIVE: This study compared the efficacy of granisetron alone with granisetron/dexamethasone combination for the treatment of nausea and vomiting after major gynecologic surgery. METHODS: In this randomized, double-blind study, patients who were experiencing emetic symptoms during 0 to 3 hours after the end of anesthesia administration received granisetron 40 microg/kg i.v. either alone or in combination with dexamethasone 8 mg. Patients then were observed for 24 hours after study drug administration, with emetic episodes recorded and tolerability assessments performed by nursing staff blinded to treatment. RESULTS: A total of 120 women were enrolled (n = 60 in each treatment group; mean [SD] age in the granisetron group, 44 [9] years [range, 23-63 years]; combination group, 45 [8] years [range, 21-65 years]). No significant differences in patient demographic characteristics were found between the 2 treatment groups. However, the percentage of patients free of emetic symptoms (nausea, retching, vomiting) was higher in the granisetron/dexamethasone combination group than in the granisetron group (95.0% and 80.0%, respectively; P = 0.012). No clinically serious adverse events attributed to the study drugs were observed in either group. CONCLUSION: In this study, the granisetron/dexamethasone combination was more effective than was granisetron alone for the management of nausea and vomiting during 0 to 3 hours after anesthesia in women undergoing major gynecologic surgery.

Adult↗
PubMed1987

Vascular injuries during gynecologic surgery.

Iatrogenic vascular injuries are common in the civilian western world. The frequency seen following gynecologic surgery is not known and a questionnaire was therefore sent to all gynecologic clinics in Sweden undertaking surgery, to establish the frequency during a 5-year period and to analyse the types of injury. Case reports in the literature were also analysed. The frequencies per 10,000 operations were: after laparoscopy, 0.93, after laparotomy, 0.76 and after major vaginal surgery, 0.33. All laparoscopic injuries were localized to the iliac arteries, caused bleeding, and were treated with arterial suture without complications or late sequelae. Injuries during laparotomy were most frequently venous and all patients had hemorrhage as the main symptom. In one case the external iliac vein was ligated, with immediate postoperative swelling, and in another case the external iliac artery was ligated, after which the patient developed postoperative ischemia. The internal iliac veins were ligated, and the other vessels reconstructed. There was no mortality, but a high rate of morbidity, also with late sequelae.

Adult↗
PubMed1995

A random trial comparing recovery after midazolam-alfentanil anesthesia with and without reversal with flumazenil, and standardized neurolept anesthesia for major gynecologic surgery.

STUDY OBJECTIVE: To compare the recovery characteristics of total intravenous anesthesia (TIVA) using midazolam-alfentanil, with or without reversal with flumazenil to a standardized neurolept anesthesia with nitrous oxide (N2O). DESIGN: Randomized, double-blinded clinical study. SETTING: University medical center. PATIENTS: 80 ASA physical status I and II women scheduled for major elective gynecologic surgery. INTERVENTIONS: Patients were anesthetized with one of three different anesthetic techniques. Patients in the TIVA group with reversal received midazolam-alfentanil reversed with flumazenil (Group 1), the TIVA group without reversal received midazolam-alfentanil reversed with placebo (Group 2), and patients in the neurolept group received anesthesia using thiopental sodium, droperidol, fentanyl, and N2O (Group 3). MEASUREMENTS AND MAIN RESULTS: Recovery was assessed by an observer blinded to the treatment allocation, using a Modified Steward Recovery Score and judgment of orientation and comprehension, collaboration and degree of sedation for the first 4 hours after extubation. Arterial blood gases were measured 30 minutes after extubation. A questionnaire regarding the degree of perioperative amnesia was presented to the patients 4 and 24 hours after surgery. The recovery scores were better in the TIVA group with reversal than in the other two groups from 0 to 30 minutes postoperatively. No difference between the groups could be found thereafter, although after 30 minutes some resedation occurred in the TIVA group with reversal. The median injected amount of flumazenil in Group 1 was 0.5 mg. Respiratory depression (breathing frequency below 10 breaths/min) was reversed with naloxone in one patient in the TIVA group with reversal, five patients in the TIVA group without reversal, and no patient in the neurolept group (p < 0.001). On blood gas analysis, there was no evidence of hypoxemia or carbon dioxide retention. No difference was seen between the groups regarding consumption of analgesics, degree of amnesia, or patient rating of the quality of anesthesia. One patient in Group 2, however, recorded awareness at skin incision when questioned 4 hours after the operation, but could not recall this 20 hours later. CONCLUSIONS: TIVA with midazolam and alfentanil can be used for major gynecologic surgery. Recovery in the neurolept group was equal to recovery in the TIVA group without reversal, and flumazenil improves the recovery after midazolam anesthesia. Overall, in comparison with the neurolept technique no major advantage could be demonstrated using TIVA with midazolam-alfentanil.

Adult↗
PubMed1999

Cost-effectiveness of prophylactic dolasetron or droperidol vs rescue therapy in the prevention of PONV in ambulatory gynecologic surgery.

PURPOSE: To assess the cost-effectiveness of prophylactic therapy (1.25 mg droperidol or 50 mg dolasetron i.v.) vs no prophylaxis (rescue therapy) for the prevention of post-operative nausea and vomiting (PONV) from a Canadian hospital perspective. METHODS DESIGN: A predictive decision analytic model using previously published clinical and economic evaluations, and costs of medical care in Canada. SUBJECTS: Ambulatory gynecology surgery patients. INTERVENTIONS: Three strategies administered prior to emergence from anesthesia were compared: 1.25 mg droperidol i.v., 50 mg dolasetron i.v.; and no prophylaxis (rescue therapy). RESULTS: The base case mean cost per patient receiving dolasetron prophylaxis was $28.08 CAN compared with $26.88 CAN per patient receiving droperidol prophylaxis, resulting in a marginal cost of $1.20 CAN. This difference translated in an additional cost of $12.00 CAN for the dolasetron strategy per adverse event avoided over the droperidol strategy. The base case mean cost per patient not receiving prophylaxis was $26.92 resulting in marginal costs of $1.16 CAN and $0.04 CAN when compared to dolasetron and droperidol, respectively. Compared with the no prophylaxis strategy, dolasetron prophylaxis resulted in an incremental cost-effectiveness ratio of $5.82 CAN per additional PONV-free patient. The mean costs incurred per PONV-free patient were calculated to be $48.41 for the dolasetron strategy, $46.34 for the droperidol strategy and $70.83 for the no prophylaxis strategy. CONCLUSIONS: Dolasetron and droperidol given intraoperatively were more cost-effective than no prophylaxis for PONV in patients undergoing ambulatory gynecologic surgery. The difference between the two agents was small and favoured droperidol. The model was robust to plausible changes through sensitivity analyses.

Ambulatory Surgical Procedures↗
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

Internal and external measures of quality assurance in gynecological surgery.

In the light of exploding costs in health care and increasing demands for public accountability, gynecological surgeons are forced to improve the effectiveness and efficiency of their care in order to increase the satisfaction of their 'clients'. To do so, the implementation of a structured quality management system in gynecological care units is strongly encouraged. Basic requirements for an efficient quality management system comprise developing appropriate structures for the system, training staff in management techniques and using tools to monitor the quality of care. An important part of a quality management system is structured data collection permitting regional benchmarking between hospitals. The study 'Quality assurance in gynecological surgery' of the German Society of Gynecology and Obstetrics is mentioned as an example of such an external measure. Profiles help gynecological care units to recognize problem areas of their care. A list of further structural characteristics of a quality-oriented gynecological care unit, such as second opinion techniques or the application of clinical practice guidelines, is given to enable the evaluation or certification of quality management systems in gynecological departments.

Accreditation↗
PubMed2002

Adequacy of oophorectomy at the time of gynecologic surgery.

OBJECTIVES: To determine the incidence of incomplete ovarian removal during gynecologic surgery and correlate the risk of inadequate removal with the procedure chosen. METHODS: This is a prospective observational study. Ovaries received during a 4-month period in the participating institutions were independently histologically evaluated. Gross inspection of the ovarian capsule, infundibulopelvic ligament, hilum and utero-ovarian ligament was assessed. Grossly close margins were confirmed histopathologically. Any margin with histologically confirmed ovarian tissue at the margin was interpreted as incompletely removed. Details of each surgical procedure were recorded for comparison. RESULTS: Ovaries (n=174) from 94 patients were collected and 155 were evaluable. The overall incidence of incomplete ovarian removal was 6.5%. Of the 125 ovaries removed abdominally, 23 were laparoscopically assisted and 7 were vaginal; inadequate removal was documented in 5%, 9% and 29%, respectively (P=0.04). There was no relationship of inadequate resection by underlying pathologic diagnosis (P=0.25) or by institution (4.6% university hospital vs. 8.8% community hospital; P=0.29). CONCLUSIONS: Incomplete ovarian removal occurs and is related to surgical approach. A larger study is warranted to evaluate the role of pelvic pathology or surgeon experience as a risk for incomplete oophorectomy.

Female↗
PubMed2006

[Study of analgestic efficacy of ropivacaine-fentanyl patient-controlled epidural analgesia after upper abdominal gynecological surgery].

BACKGROUND: Most of the patients who undergo radical or subradical hysterectomy with paraaortic lymphadenectomy suffer from postoperative pain for upper abdominal incision. They also complain of postoperative nausea and vomiting (PONV) frequently, which are increased by opioids. METHODS: Reducing total fentanyl dose to 0.6 mg, frequency of moving pain complaints increased gradually. Therefore, we introduced patient-controlled epidural analgesia (PCEA) for suppressing pain on moving. We investigated analgestic efficacy of 0.2% ropivacaine-fentanyl PCEA in twelve patients undergoing upper abdominal gynecological surgery. Postoperative analgesic effects were evaluated by visual analogue scale (VAS) at rest and on moving, times of bolus infusion, side effects, and degrees of satisfication by patient's self-assessments. Continuous epidural infusion of 0.6 mg fentanyl in 288 ml 0.2% ropivacaine was started at a rate of 4 ml x hr(-1) with a bolus dose of 2 ml. RESULTS: VAS was maintained below 20 mm at rest but was elevated to the maximum of 45 mm on moving with few bolus requests. Ninty-two percents of the patients answered satisfied but fifty percents of them had PONV. CONCLUSIONS: We conclude that ropivacaine-fentanyl PCEA is effective after upper abdominal gynecological surgery, and we can decrease the dose of fentanyl by explaining PCEA system more effectively to the patients for suppressing the pain on moving and PONV.

Adult↗
PubMed1992

Comparative study of single-dose cefotaxime and multiple doses of cefoxitin and cefazolin as prophylaxis in gynecologic surgery.

In this comparative, randomized, multicenter trial, 273 patients scheduled for gynecologic surgery were studied: 87 received a single 1-g dose of cefotaxime 30 minutes before surgery; 81 were given a 1-g dose of cefoxitin 30 minutes before surgery and 1 g every 6 hours for 24 hours after surgery (total dose 4 g); and 105 received a 1-g dose of cefazolin 30 minutes before surgery, followed by 1 g every 8 hours for 48 hours (total dose 6 g). Patients who received cefotaxime had a significantly lower incidence of postoperative fever compared with those treated with cefoxitin or cefazolin (p < 0.01). The incidence of positive urinary cultures was lower in the cefotaxime and cefazolin groups when compared with the cefoxitin group (p < 0.01 and p < 0.05, respectively). The results of this study confirm the efficacy of cefotaxime as prophylaxis in surgical infections and demonstrate that single-dose cefotaxime is more effective than a four-dose regimen of cefoxitin.

Adolescent↗
PubMed1990

Antibiotic prophylaxis in gynecological surgery.

A randomized prospective study was undertaken at the Obstetrics and Gynecology Clinic of the Catholic University of Rome in order to evaluate the effectiveness of two wide spectrum antibiotics: mezlocillin and cefotetan. Both drugs were administered 2 g i.v. 15 to 20 minutes preoperatively to allow optimal serum and tissue levels of antibiotic at the moment of bacterial innoculation. 184 patients undergoing elective gynecological surgery for nonmalignant disease were considered eligible for the study (124 pts abdominal hysterectomy, 58 pts vaginal hysterectomy). We found no statistically significant differences between the results obtained with the two drugs.

Adult↗
PubMed1992

[Preventive and therapeutic use of cefriaxon in gynecologic surgery].

The Authors have been investigating the behaviour of ceftriaxone in gynecological surgery employing 1 g of the drug through intravenous injection an hour before the operation, after executing a cutaneous pomphus the night before. They obtained satisfactory results since out of 25 cases analyzed nowhere had they to intervene with other antibiotics. The drug, despite the 15 cases of infectious pathology observed, has been showing great tolerance and an utmost ease and usefulness of usage.

Ceftriaxone↗
PubMed1989

Piperacillin for prophylaxis in gynecological surgery.

The effectiveness of perioperative Piperacillin for prevention of operative-site infection after gynaecological surgery was studied in a total of 100 patients. In an open randomized clinical trial of 52 women undergoing abdominal or vaginal hysterectomy Piperacillin was compared to the combination Gentamicin/Metronidazole. Piperacillin was well-tolerated. Surgical-site infection was diagnosed in the Piperacillin group in two patients and in the Gentamicin/Metronidazole group in one patient. The occurrence of postoperative febrile morbidity was also similar between the two group. In 48 patients undergoing complicated gynecological surgery of long duration, only Piperacillin was administered perioperatively. Thirty-five of these 48 women underwent oncological operations and the mean operative length was 3.3 h. One patient developed a transient rash after the administration of Piperacillin. No other adverse side-effects were observed. Nine of these 48 patients developed a surgical-site infection postoperatively, and this was found to be significantly more often than in the first group of 52 patients. It was concluded that Piperacillin seems to be a valuable alternative for perioperative prophylaxis in gynecological surgery. Its effectiveness in vaginal and abdominal hysterectomy is similar to the combination of Gentamicin/Metronidazole, but after complicated surgery of long duration a decreased effectiveness should be reckoned with.

Bacterial Infections↗
PubMed2003

Transvaginal ultrasound-assisted gynecologic surgery: evaluation of a new device to improve safety of intrauterine surgery.

OBJECTIVE: The purpose of this study was to evaluate a new device that couples any standard transvaginal ultrasound transducer to a special tenaculum by means of a specially designed adaptor that enables real-time ultrasound imaging and guidance of intrauterine surgical procedures. STUDY DESIGN: Forty-five patients who underwent intrauterine surgical interventions were evaluated. Forty of these patients had pregnancy terminations. Three patients had curettage for early pregnancy complications. One patient had a polyp removed, and one patient underwent hysteroscopic submucous myomectomy. Five attending physicians performed 26 procedures. Four residents in training performed 19 procedures. All operators were instructed in the assembly and use of the device before their first procedure. Evaluation of the device was done by means of a detailed questionnaire. RESULTS: The procedures were completed successfully and without complications. The time that was involved for the various components of the surgical procedures was recorded; 83% to 90% of the time the operators felt that the technique increased safety and accuracy for the parameters that were evaluated. They required fewer intrauterine instrument manipulations; in 85% of the cases, they could detect the exact end point of the procedure more accurately. In 12% of cases, the operators felt that the device interfered with the performance of the procedure. CONCLUSIONS: The transvaginal ultrasound-assisted gynecological surgery system provided high-resolution images of the cervical canal and the uterine cavity during all stages of the procedure and provided improved indication of the procedure's end point. The increased safety and accuracy that was reported by most users was encouraging. The transvaginal ultrasound-assisted gynecologic surgery system appears to provide an enhanced alternative to transabdominal ultrasound guidance for intrauterine surgical procedures.

Abortion, Induced↗