Dolasetron for the prevention of postoperative nausea and vomiting following outpatient surgery with general anaesthesia: a randomized, placebo-controlled study. The Dolasetron PONV Prevention Study Group.

In a multicentre, randomized, double-blind, placebo-controlled dose-ranging study, 1030 patients undergoing outpatient surgery with general anaesthesia received i.v. dolasetron mesylate (12.5, 25, 50, or 100 mg) or placebo. The principal outcome measure was the proportion of patients who were free of emesis or rescue medication for the 24-h period after the study drug was given; the subsidiary outcome measure was survival time without rescue medication. Effects on nausea were quantified using a visual analogue scale. Compared with placebo, a complete response was significantly higher when all four dolasetron doses were combined (49% vs. 58%, P =0.025). In females, dolasetron, 12.5-mg, dolasetron provided maximum clinical benefit (effectiveness compared with adverse events), with no additional benefit in complete response rates or nausea visual analogue scale scores at higher doses. No significant differences were observed in complete response for any dolasetron dose in males compared with placebo. The majority of adverse events reported were mild or moderate. Dolasetron provided well-tolerated, safe, and effective prophylaxis for post-operative nausea and vomiting with maximum effectiveness observed at a dose of 12.5 mg.

A comparison of the efficacy, safety, and patient satisfaction of ondansetron versus droperidol as antiemetics for elective outpatient surgical procedures. S3A-409 and S3A-410 Study Groups.

UNLABELLED: Two identical, randomized, double-blind, placebo-controlled studies enrolled 2061 adult surgical outpatients at high risk of postoperative nausea and vomiting (PONV) to compare i.v. ondansetron 4 mg with droperidol 0.625 mg and droperidol 1.25 mg for the prevention of PONV. The antiemetic drugs or placebo were administered i.v. 20 min before the induction of anesthesia with a barbiturate compound, followed by maintenance with N2O/isoflurane/enflurane. Nausea, emetic episodes, adverse events, and patient satisfaction were analyzed for the 0 to 2 h and 0 to 24 h postoperative periods. In the 0 to 2 h postoperative period, there was a complete response (no emesis or rescue antiemetic) in 46% of subjects given placebo (P < 0.05 versus antiemetic groups), in 62% given ondansetron, in 63% given droperidol 0.625 mg, and in 69% given droperidol 1.25 mg (P < 0.05 versus ondansetron). In the 0 to 24-h postoperative period, there were no significant differences in complete response between the ondansetron and droperidol 0.625 or 1.25 mg groups; all groups remained superior to placebo. The proportion of patients without nausea during the 0 to 24 h postoperative period was greater in the antiemetic groups compared with the placebo group; however, droperidol 1.25 mg was more effective than ondansetron 4 mg or droperidol 0.625 mg (43% vs 29% or 29%, respectively). Headache incidence was higher in the ondansetron group compared with either droperidol group. Patient satisfaction scores did not differ significantly among antiemetic treatment groups, although all were superior to placebo. In conclusion, all antiemetic treatment regimens were superior to placebo for the prevention of PONV in the immediate postoperative period; however, droperidol 1.25 mg was more efficacious than ondansetron during the early recovery period (0-2 h). There were no significant differences between ondansetron and either droperidol dose for emesis prevention during the 0 to 24 h postoperative period. IMPLICATIONS: More than 2000 patients at high risk of postoperative nausea and vomiting were given either placebo, ondansetron 4 mg, or droperidol 0.625 mg or 1.25 mg i.v. before the administration of general anesthesia. After surgery, the incidence of nausea, vomiting, medication side effects, and patient satisfaction were evaluated for 24 h. Droperidol 0.625 or 1.25 mg i.v. compared favorably with ondansetron 4 mg i.v. for the prevention of postoperative nausea and vomiting after ambulatory surgery.

A multicenter comparison of maintenance and recovery with sevoflurane or isoflurane for adult ambulatory anesthesia. The Sevoflurane Multicenter Ambulatory Group.

Sevoflurane was compared with isoflurane in 246 adult ASA class I-III patients undergoing ambulatory surgery. After administration of midazolam 1-2 mg and fentanyl 1 microgram/kg, anesthesia was induced with propofol 2 mg/kg and maintained with either sevoflurane or isoflurane in 60% nitrous oxide to maintain arterial blood pressure at +/- 20% of baseline. Fresh gas flows were 10 L/min during induction and 5 L/min during maintenance. Times to eye opening, command response, orientation, and ability to sit without nausea and/or dizziness were significantly faster after sevoflurane. Significantly more sevoflurane patients met Phase 1 of postanesthesia care unit (PACU) Aldrete recovery criteria (> or = 8) at arrival, 95% vs 81%. Also, significantly more sevoflurane patients were able to complete psychomotor recovery tests during the first 60 min postanesthesia. Discharge times were not different. Sevoflurane patients had significantly lower incidences of postoperative somnolence (15% vs 26%) and of nausea both in the PACU (36% vs 51%) and in the 24-h postdischarge period (9% vs 24%). Patient satisfaction was high overall (sevoflurane 97%, isoflurane 93%). We conclude that sevoflurane is a useful inhaled anesthetic for maintenance of ambulatory anesthesia.

Treatment of postoperative nausea and vomiting after outpatient surgery with the 5-HT3 antagonist ondansetron.

BACKGROUND: Postoperative nausea and vomiting following outpatient surgery can significantly delay discharge. This study evaluates the safety and efficacy of ondansetron (a new 5-HT3 antagonist) in the treatment of postoperative nausea and vomiting in patients following outpatient surgery. METHODS: Five hundred outpatient surgical patients (53 male and 447 female), receiving general endotracheal anesthesia, were studied at ten centers. Patients were stratified by gender and received, in a randomized, double-blind manner, 1, 4, or 8 mg ondansetron or placebo in response to nausea and/or vomiting postoperatively. Episodes of vomiting, nausea scores, adverse events, vital signs, and laboratory values were evaluated before and during the 24 h after study drug administration. RESULTS: Complete response to study medication (no vomiting and/or retching, and no rescue antiemetic over the initial 0-2-h period) was more frequent in the ondansetron groups (1 mg 57%, 4 mg 61%, and 8 mg 57%) than in the placebo group (30%, P < .001). For the 0-24-h study a complete response occurred in only 15% of the placebo group compared to 41%, 47%, and 47% of the 1-, 4-, and 8-mg ondansetron groups, respectively (P < .001 for all comparisons with placebo). Median nausea scores (range 0-10) during the initial observation period (0-2 h) were significantly lower for all doses of ondansetron (1.3, 0.8, 1.8 for 1, 4, and 8 mg, respectively) as compared with placebo (2.3). No significant differences occurred in hemodynamic stability, incidence of adverse events, or changes in laboratory values in the ondansetron groups compared to the placebo group. CONCLUSIONS: Ondansetron, in doses less than 8 mg, is a safe, effective antiemetic for treating postoperative nausea and vomiting.

A double-blind, placebo-controlled pilot study examining the effectiveness of intravenous ondansetron in the prevention of postoperative nausea and emesis.

STUDY OBJECTIVE: To compare the efficacy and safety profiles of ondansetron and a placebo when infused immediately prior to anesthesia induction for the prevention of postoperative nausea and emesis (vomiting or retching). DESIGN: Randomized, double-blind, placebo-controlled, parallel, multicenter pilot study. SETTING: Three U.S. ambulatory surgical facilities. PATIENTS: One hundred eighty ASA physical status I and II women scheduled to undergo ambulatory gynecologic surgical procedures while receiving general endotracheal anesthesia. INTERVENTIONS: Ondansetron 8 mg or a placebo (equivalent volume) was given intravenously (IV) prior to anesthesia induction to prevent postoperative nausea and vomiting. MEASUREMENTS AND MAIN RESULTS: For the first 24 hours following emergency from anesthesia, patients were monitored in the postanesthesia care unit by a research observer and at home via telephone contact and diary cards. More patients in the ondansetron group (62%) than in the placebo group (40%) were emesis-free over the 24-hour study period (p = 0.005). Ondansetron also was more efficacious than the placebo over the 24-hour study period when a surgery duration of more than 45 minutes was considered in the analyses. For all patients, regardless of surgery duration, there was a low degree of nausea during the course of the study. In all instances, the degree of nausea was slightly lower for ondansetron-treated patients than for placebo-treated patients; however, in no instances were the differences statistically significant. Ondansetron and placebo had similar safety profiles as established by laboratory test results, vital sign monitoring, and adverse event reporting. CONCLUSION: Ondansetron, infused IV before anesthesia induction, appears to be safe and effective when used in the prevention of postoperative nausea and emesis.

Ondansetron in the treatment of postoperative nausea and vomiting in ambulatory outpatients: a dose-comparative, stratified, multicentre study.

The safety and efficacy of ondansetron were evaluated in the treatment of postoperative nausea and vomiting. Five hundred patients who experienced nausea or vomiting in the Post-Anaesthesia Care Unit within the first 2 h of recovery were randomized to receive either 1, 4, or 8 mg of ondansetron, or placebo. All patients had undergone ambulatory surgery with general endotracheal anaesthesia. Episodes of emesis, nausea scores, adverse events, vital signs, and laboratory values were assessed before and during the 24 h after study drug administration. Patients were evaluated for the first 2 h in the Post-Anaesthesia Care Unit then followed up for the next 22 h. Complete response was defined as no emetic episodes, no nausea or no rescue anti-emetic medication. For the 0-24 h study period, complete response occurred in only 15% of the placebo group compared to 41%, 47%, and 47% in the 1, 4, and 8 mg ondansetron groups, respectively. Mean nausea scores (scale of 0-10) during the initial observation period (0-2 h) were significantly lower for all doses of ondansetron [2.2 (1 mg), 1.7 (4 mg), and 2.1 (8 mg)] compared to placebo (3.0). The optimal dose of ondansetron for the treatment of postoperative nausea and vomiting was found to be 4 mg. All doses of ondansetron were well tolerated. No clinically significant increases in laboratory parameters or alterations in haemodynamic stability occurred in the ondansetron groups compared to placebo.

Safety of outpatient cerclage.

One hundred one women who underwent scheduled McDonald cerclage were studied. Fifty outpatients were reviewed prospectively, and 51 inpatients were studied retrospectively and concurrently. Forty-five outpatients and 48 inpatients completed pregnancy. The fetal outcomes were similar for both groups, with no significant differences in the number of complications for newborn infants. The average cost of the procedure (exclusive of physician fees) for outpatient cerclage was $546 and for inpatient, $1,174. The difference clearly shows the cost-effectiveness of outpatient cerclage.

A comparison of recovery in outpatients receiving fentanyl versus those receiving butorphanol.

The frequency of postanesthesia side effects and times to reach "benchmarks" in the recovery process for IV preinduction doses of 20 micrograms/kg butorphanol, 40 micrograms/kg butorphanol, or a 2 micrograms/kg dose of fentanyl were compared in a double-blinded study involving ambulatory surgical patients. The authors hypothesized that all drugs would perform equally well in all study areas. Sixty ASA physical status I and II women undergoing laparoscopic tubal sterilization were randomly assigned to one of three groups: Group I (n = 20) received 20 micrograms/kg butorphanol as a preinduction agent; Group II (n = 20) received 40 micrograms/kg butorphanol; Group III (n = 20) received 2 micrograms/kg fentanyl. Anesthesia management for all groups was the same. Statistically significant variance was found in time to discharge-ready status and duration of nausea (p less than 0.05) between 40 micrograms/kg butorphanol and 2 micrograms/kg fentanyl, but no significant difference was found between 20 micrograms/kg butorphanol and 2 micrograms/kg fentanyl in these areas. Statistically significant variance was found in duration of dizziness and time to obtain a 10 on the Aldrete Post Anesthesia Recovery Score (APARS) between 40 micrograms/kg butorphanol and 20 micrograms/kg butorphanol and 40 micrograms/kg butorphanol and 2 micrograms/kg fentanyl. From the study, 20 micrograms/kg butorphanol appears to be as suitable as 2 micrograms/kg fentanyl for use as a preinduction narcotic analgesic, whereas 40 micrograms/kg butorphanol appears to be unsuitable due to increased duration of nausea, dizziness, and time to score 10 on APARS and reach discharge-ready status.

Bupivacaine infiltration of the mesosalpinx in ambulatory surgical laparoscopic tubal sterilization.

Bupivacaine infiltration of the mesosalpinx was compared to lidocaine, normal saline or no injection for pain relief in women having elective laparoscopic tubal sterilization by Yoon fallopian ring application. One hundred women were assigned randomly to four groups. In a double-blind study, the mesosalpinx was infiltrated in three groups: Group 1 - lidocaine one per cent; Group II - bupivacaine 0.5 per cent; Group III - normal saline. Group IV (control) received no injection. Pain intensity was reported at four study times by the patients on a self-assessment pain intensity scale. Responses were compared using the Kruskall-Wallis H-Test and Wilcoxen's Rank-Sum Test. Both tests indicated significant differences in pain intensity levels at various study times. The amount of supplemental fentanyl given was used as a secondary measure of effectiveness. One-way analysis of variance (ANOVA) and Duncan's Multiple-Range Test showed the bupivacaine group to receive significantly less fentanyl (p less than 0.05) in the postanaesthesia care unit.

Infiltration of the mesosalpinx for pain relief after laparoscopic tubal sterilization with Yoon rings.

Approximately 200 women of American Society of Anesthesiologists class I and II physical status electing outpatient laparoscopic tubal sterilization with Yoon rings were involved in a double-blind study to evaluate postoperative pain relief after intraoperative suprapubic infiltration of the fallopian mesosalpinx. The postoperative pain levels were lower after bilateral infiltration of 0.5% bupivacaine beneath the site of ring application. Postoperative, suprapubic infiltration provided safe, prolonged and effective pain relief, allowed prompt ambulation and early discharge, and reduced the need for narcotic analgesics and postoperative analgesia.

PIP: A double-blind study involving close to 200 American Society of Anesthesiologists physical status I or II women ranging from 21-40 years of age, all of whom were scheduled for elective outpatient laparoscopic tubal sterilization with Yoon rings, was carried out to evaluate postoperative pain relief after infiltration of mesosalpinx. 4 study groups were matched for age, weight, and general health status. The 1st 3 groups were infiltrated with lidocaine, bupivacaine, and normal saline solution, respectively. The 4th group was not infiltrated. Pain levels were recorded through use of a self-assessment intensive pain scale administered at 4 points up to 24 hours after surgery. At all 4 points of reference, group 2 patients--those infiltrated with 0.5% bupivacaine--had statistically significantly lower pain levels than those in groups 1, 3, and 4. Since women in group 2 demonstrated a significant reduction in narcotic analgesia requirements during recovery, there was less nausea and respiratory depression. There was also a decrease in postoperative pelvic distress.

Outpatient general and spinal anesthesia.

By the year 1990, it is projected that 50 per cent of all surgery in the United States will be performed on an outpatient basis. Both surgeons and anesthesiologists must understand patient and procedure prerequisites for outpatient surgery. The surgeon, prior to scheduling the operation, must evaluate the patient as to acceptability and provide that patient with complete information about the proposed outpatient experience. Anesthesia techniques (premedication, intravenous, inhalational, regional) must be modified and adapted to accomplish early patient ambulation and discharge to home on the same day as surgery. Patients must meet established clinical criteria prior to discharge and must be examined by a physician at the time these criteria have been met. The physician's clinical judgment is the single most important factor in determining the patient's home readiness.

Patient selection criteria for 1987.

Patient selection criteria provides an effective means for assessing the appropriateness of patients for surgery in an outpatient setting. Thorough evaluation in each of the five criteria areas helps ensure the acceptability of each patient for ambulatory surgery. Regardless of the development of new procedures, anesthetic agents, and equipment, the use of patient selection criteria is still one of the most important factors in determining the overall outcome and success of the patient's ambulatory surgery experience.