Ondansetron versus placebo for prophylaxis of nausea and vomiting in patients undergoing ambulatory laparoscopic cholecystectomy

BACKGROUND: Postoperative nausea and vomiting is a common problem in patients undergoing laparoscopic cholecystectomy (LC). The purpose of this study was to evaluate the efficacy of ondansetron given at the induction of anesthesia in patients scheduled for ambulatory LC. METHODS: A total of 84 patients undergoing ambulatory LC were enrolled in a randomized, prospective, double-blinded study in which the subjects received either placebo or 4 mg ondansetron intravenously at induction of anesthesia. A nausea scoring system was employed utilizing a 5-point linear scale, with 1 point given for no nausea and a maximum of 5 points for an episode of emesis. Each patient received a total of four scores postoperatively. RESULTS: The patients receiving placebo had significantly more episodes of nausea (53 versus 32; P <0.009) and emesis (11 versus 2; P <0.02), higher mean total nausea scores (7.2 versus 5.4; P <0.006), and need for additional postoperative antiemetics (23 versus 14; P <0.05) than those receiving ondansetron. CONCLUSIONS: In patients undergoing ambulatory laparoscopic cholecystectomy, ondansetron at induction was highly effective in decreasing postoperative nausea and vomiting and should become the standard.     

Metoclopramide versus ondansetron in prophylaxis of nausea and vomiting for laparoscopic cholecystectomy.

BACKGROUND: Postoperative nausea and vomiting are significant problems in laparoscopic surgery. This double-blind, randomized, prospective trial compares the prophylactic use of metoclopramide, ondansetron, and placebo for the treatment of postoperative nausea and vomiting in patients undergoing outpatient laparoscopic cholecystectomy. METHODS: Two hundred thirty-two patients aged 18 to 73 years were randomized into three groups. Patients received intravenously 10 mg of metoclopramide, 4 mg of ondansetron, or placebo in a double-blinded manner prior to surgery. RESULTS: The incidence of nausea was 32% for metoclopramide, 45% for ondansetron, and 44% for placebo in the postanesthesia care unit or day surgery, which was not statistically significant. The incidence of vomiting was 8% for metoclopramide, 4% for ondansetron, and 22% for placebo in the postanesthesia care unit or day surgery. These differences were statistically significant when comparing both drugs to placebo but not when comparing both drugs to each other. CONCLUSION: Prophylactic administration of metoclopramide or ondansetron significantly reduces the incidence of postoperative vomiting for laparoscopic cholecystectomy, but neither drug was found to be significantly more effective than the other. Metoclopramide is a more cost-effective treatment.     

枢复宁预防全麻腹部手术后恶心和呕吐的临床研究

全麻患者术后常易发生恶心、呕吐，枢复宁有抗呕吐作用。随机选择１００例腹部外科手术患者，分为枢复宁组（４ｍｇ，ｎ＝５０）和安慰剂组（生理盐水，ｎ＝５０），诱导前静注枢复宁或安慰剂，注速１分钟，双盲法观察术后２４小时抗恶心、呕吐效果及副作用。结果表明，用药组恶心、呕吐发生率（１８％，０）明显低于安慰剂组（５０％，４０％）（Ｐ＜０．０１），两组患者的平均动脉压、经皮血氧饱和度，呼吸频率和心率，血液成分，肝、肾功能无明显改变。因此，枢复宁适用于腹部外科患者术后恶心、呕吐的防治。     

Prophylaxis with oral granisetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a prospective randomized study

HYPOTHESIS: Laparoscopic cholecystectomy is associated with a relatively high incidence of postoperative nausea and vomiting when no prophylactic antiemetic is given. This study assesses the efficacy and safety of oral granisetron hydrochloride for the prevention of nausea and vomiting after laparoscopic cholecystectomy. DESIGN: A prospective, randomized, double-blind, placebo-controlled study. SETTING: University teaching hospital. PATIENTS: The study comprised 120 patients, 92 women and 28 men, undergoing laparoscopic cholecystectomy. INTERVENTIONS: Patients received orally either placebo or granisetron at 3 different doses (1 mg, 2 mg, and 4 mg; n = 30 of each) 60 minutes before surgery. A standard general anesthetic technique and postoperative analgesia were used. MAIN OUTCOME MEASURES: Emetic episodes were recorded during the first 24 hours after anesthesia. RESULTS: The incidence of patients who were emesis-free 24 hours after anesthesia was 60% with 1 mg of granisetron (P =.40), 83% with 2 mg of granisetron (P =.01), and 83% with 4 mg of granisetron (P =.01), compared with placebo (53%). No clinically important adverse effects were observed in any of the groups. CONCLUSION: Preoperative oral granisetron in doses higher than 2 mg is effective for the prevention of nausea and vomiting after laparoscopic cholecystectomy.     

Tropisetron vs ondansetron for prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy: a randomized double-blind,placebo-controlled study

Background: Postoperative nausea and vomiting are observed in increased frequency after laparoscopic surgery. This study was performed in order to compare the efficacy of two 5-hydroxytryptamine-3 (5-HT3) receptor antagonists, ondansetron and tropisetron, in preventing postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. Methods: Using a randomized, double-blind study design, 87 ASA I and II patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive 4 mg ondansetron (Group A, n = 29), 5 mg tropisetron (Group B, n = 31), or placebo (Group C, n = 27) intravenously (IV) before induction of anesthesia. The end points evaluated were frequency of nausea, nausea intensity rated on a scale from 1 (mild) to 5 (most severe), frequency of vomiting, and need for rescue antiemetics. These parameters were measured immediately after surgery (0 h), at 3 h, 6 h, and 12 h postoperatively. Results: The frequency of nausea was significantly higher in group A (31.2%) compared to group B (14%) at 12 h postoperatively (p <0.01). However, patients of group A had significantly lower nausea scores at 3 h postoperatively compared to group B. Postoperative vomiting occurred in 13.8% of patients in group A and 9.6% of patients in group B throughout the whole study period (p = n.s.). The need for rescue antiemetics was similar between groups A and B. Both groups were superior to placebo concerning all studied parameters. Conclusion: Our results show that ondansetron may be more effective in controlling nausea intensity during the first 3 h after laparoscopic cholecystectomy, while tropisetron has a longer-acting activity, with a major impact on nausea frequency at 12 h postoperatively.     

Ondansetron in the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy

Background: There is an increased incidence of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. The aim of the study was to evaluate the efficacy of intravenous ondansetron, a 5-HT anatagonist, for prevention from PONV after laparoscopic cholecystectomy. Methods: Sixty-eight patients were entered into the study. Thirty-six patients were randomized to receive a single intravenous dose of 4 mg of ondansetron before extubation. Thirty-two patients received no prophylaxis. There were no differences in terms of sex ratio, age, ASA status, and duration of operation between the two study groups. Patients were interviewed by an independent observer to assess the postoperative pain and nausea using visual analog score. Patients' satisfaction scores to the procedure were measured. Results: There was no complication in the series. Pain scores at 2 and 24 h after operation and analgesics consumption were not different between the two groups. For the patients who received ondansetron, the mean (SD) nausea score at 2 and 24 h was 1.5 (1.2) and 1.4 (1.4), respectively. The score for the control group was 1.4 (1.0) and 1.2 (0.5), respectively. There was also no difference in episodes of vomiting and usage of antiemetics between the two groups. Both groups were equally satisfied with the procedures. Conclusion: Routine use of ondansetron does not reduce the incidence of postoperative nausea and vomiting after laparoscopic cholecystectomy.     

Ondansetron, metoclopramid, dexamethason, and their combinations compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a prospective randomized study

Background A prospective randomized study was performed to assess the value of some individual risk factors for postoperative nausea and vomiting (PONV), and to compare the efficacy of ondansetron, metoclopramide, dexamethason, and combinations of these antiemetics in preventing PONV in patients after laparoscopic cholecystectomy. Methods The study enrolled 210 patients (157 women and 53 men) scheduled for laparoscopic cholecystectomy. The patients were randomly divided into seven groups. In groups 1 to 6, antiemetic drugs were administered. Group 7, the control group, received no antiemetic. For all the patients, individual risk factors for the incidence of nausea also were analyzed. Both nausea and vomiting were assessed separately 1, 4, 8, and 12 h after the procedure. Results Postoperative nausea and vomiting were significantly less frequent in menopausal women and more frequent in patients with a history of motion sickness. A comparison of mean values for the incidence of nausea and vomiting in groups 1 to 6 with the same values in group 7 showed that the mean PONV incidences were highest in groups 3 and 7, and the difference was significant. Conclusions Administration of antiemetic drugs significantly decreases the incidence of PONV in patients after laparoscopic cholecystectomy. The best decreases were achieved when ondansetron and dexamethason were applied together.     

Ondansetron versus dehydrobenzoperidol and metoclopramide for management of postoperative nausea in laparoscopic surgery patients.

BACKGROUND: In this prospective, randomized, double-blind study, we compared the efficacy of ondansetron versus dehydrobenzoperidol (droperidol) or metoclopramide in the treatment of established postoperative nausea and vomiting in 200 adult patients undergoing laparoscopic surgery under general anesthesia. METHODS: One hundred seventy-three American Society of Anesthesiologists (ASA) I and II patients satisfied inclusion criteria. Fifty-seven patients received ondansetron 4 mg (group O), 57 patients were given droperidol 1.25 mg (group D), and 59 patients received metoclopramide 10 mg (group M). Antiemetic efficacy was compared at 10 minutes and 30 minutes after the administration of the study drug. RESULTS: At 10 minutes, nausea scores in group O dropped from 8.3 to 3.7, in group D from 8.5 to 5, and in group M from 8.4 to 6.7; (P < 0.05 between the three groups). At 30 minutes, nausea scores were 1.3 in group O, 1.7 in group D, and 5 in group M; (P < 0.05 between group M and the other two groups). In the droperidol group, 25% of patients developed sedation. Patient satisfaction was best with ondansetron. CONCLUSIONS: Both ondansetron and droperidol were more effective in the treatment of established postoperative nausea and vomiting than was metoclopramide. However, patients were satisfied best with ondansetron, which acts faster and causes less sedation than droperidol.     

Ondansetron in the treatment of postoperative vomiting: a randomized, double-blind comparison with droperidol and metoclopramide.

The prophylactic antiemetic efficacy of ondansetron was evaluated in a randomized, double-blind comparison with droperidol and metoclopramide in 66 patients undergoing general anesthesia for dilatation and curettage. Ten minutes before induction of anesthesia, 22 patients received a single intravenous dose of 8 mg of ondansetron, 22 others received 1.25 mg of droperidol, and the remaining 22 received 10 mg of metoclopramide. Anesthesia was induced with 3.3-5 mg/kg of intravenous thiopental and maintained with 65% nitrous oxide in oxygen and 2%-3% enflurane. Postoperatively, the incidence of vomiting was 13% with ondansetron, 45% with droperidol, and 54% with metoclopramide (P less than 0.05; overall chi 2 test). There was no statistically significant difference in the incidence of nausea among the groups. Postoperative sedation and well-being scores were not significantly different among the groups. We conclude that preoperative prophylactic administration of ondansetron is superior to droperidol or metoclopramide in the prevention of emetic sequelae after general anesthesia for dilatation and curettage.     

Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study

Objective

This report describes the first prospective cohort study comparing transvaginal cholecystectomies (TVC) with single incision laparoscopic cholecystectomies (SILC) and four-port laparoscopic cholecystectomies (4PLC).

Methods

Between May 2009 and August 2010, 14 patients underwent a TVC. These patients were compared with patients who underwent SILC (22 patients) or 4PLC (11 patients) in a concurrent, randomized, controlled trial. Demographic data, operative time, numerical pain scales, complications, and return to work were recorded.

Results

Mean age (TVC: 33.5?±?3.0?year; SILC: 38.4?±?3.3?year; 4PLC: 35.5?±?4.1?year; p?=?0.58) and mean BMI (TVC: 28.8?±?1.5?kg/m²; SILC: 31.8?±?1?kg/m²; 4PLC: 31.4?±?2.2?kg/m²; p?=?0.35) were not statistically significant. However, mean operative time (TVC: 67?±?3.9?min; SILC: 48.9?±?2.6?min; 4PLC: 42.3?±?3.9?min; p?p?=?0.02) with equilibration of pain scores by days 14 and 30. Return to work (TVC: 6.4?±?1.5?days; SILC: 13.1?±?1.3?days; 4PLC: 14.1?±?1.4?days; p?Conclusions Transvaginal cholecystectomy is a safe and well-tolerated procedure with statistically significantly less pain at 1 and 3?days after surgery, with a faster return to work but longer operative times compared with single incision and four-port laparoscopic cholecystectomy.     

Efficacy of preoperative dexamethasone in patients with laparoscopic cholecystectomy: a prospective randomized double-blind study

Background/Purpose  Dexamethasone has been reported to reduce postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy (LC). However, its effect on other surgical outcomes such as pain and fatigue have been unclear. The purpose of this clinical study was to evaluate the efficacy of preoperative dexamethasone in ameliorating postoperative symptoms after LC. Methods  In this prospective, double-blind, placebo-controlled study, 80 patients scheduled for LC were analyzed after randomization to intravenous dexamethasone (8 mg) or placebo. All patients underwent standardized procedures for general anesthesia and surgery, and were recommended to remain in hospital for 3 postoperative days. Episodes of PONV, and pain and fatigue scores on a visual analogue scale (VAS) were recorded. Analgesic and antiemetic requirements were also recorded. Results  There were no apparent side effects of the study drug. Seven patients (18%) in the dexamethasone group reported nausea, compared with 16 (40%) in the placebo group (p = 0.026). One patient (3%) in the dexamethasone group and 7 (18%) in the placebo group reported vomiting (p = 0.025). Dexamethasone significantly reduced the postoperative VAS pain score (p = 0.030) and VAS fatigue score (p = 0.023). The mean number of patients requiring diclofenac sodium 50 mg was 0.9 ± 1.3 in the dexamethasone group and 2.2 ± 2.5 in the placebo group (p = 0.002). Conclusions  The regimen we employed is safe and without apparent side effects. These results suggest that preoperative dexamethasone (8 mg) significantly reduces the incidence of PONV, pain, and fatigue after LC.     

Quality-of-life measures after single-access versus conventional laparoscopic cholecystectomy: a prospective randomized study

Background

This study aimed to compare the short-term outcomes of single-access laparoscopic cholecystectomy (SALC) and conventional laparoscopic cholecystectomy (CLC).

Methods

In a prospective study, patients with symptomatic cholelithiasis were randomized to SALC or CLC with follow-up at 1 week, 1 and 6 months. The primary end point of this study was to assess the total outcomes of quality of life using the EuroQoL EQ-5D questionnaire. The secondary end points were postoperative pain, analgesia requirement and duration of use, operative time, perioperative complications, estimated blood loss, hospital stay, cosmesis outcome, and number of days required to return to normal activities.

Results

A total of 269 patients were prospectively randomized into two groups (125 in each group after excluding 19 patients for various reasons). The SALC procedure was done safely without intraoperative or major postoperative complications. In four SALC patients, an extra epigastric port was inserted to enhance exposure. There was no open conversion in either group. SALC patients reported better results among four of the EuroQoL EQ-5D dimensions (mobility, self-care, activity, and pain/discomfort) at 1 week after surgery, an improved pain profile at 4, 12, and 24 h, better cosmetic outcome at 1 and 6 months (P ≤ 0.01), shorter duration of need for analgesia (P ≤ 0.02), and earlier return to normal activities (P ≤ 0.026). Operative times, hospital stay, QOL at 1 and 6 months postoperatively, and estimated blood loss were similar for both procedures.

Conclusion

This study supports other studies that show that SALC is a feasible and promising alternative to traditional laparoscopic cholecystectomy in selected patients with better cosmesis, QOL, and improved postoperative pain results, and it can be performed with the existing laparoscopic instruments.     

RETRACTED ARTICLE: Dolasetron, but not metoclopramide prevents nausea and vomiting in patients undergoing laparoscopic cholecystectomy

PURPOSE: Postoperative nausea and vomiting (PONV) is one of the most frequent complications of general anesthesia. The aim of the study was to compare the antiemetic efficacy of dolasetron and metoclopramide after inhalational or i.v. anesthesia (IVA). METHODS: In a randomized, placebo-controlled, double-blinded trial we evaluated the efficacy of 12.5 mg dolasetron i.v. and 20 mg metoclopramide (MCP) i.v. in preventing PONV in 387 patients (ASA I-III) undergoing laparoscopic cholecystectomy. Patients were allocated randomly to one of three main groups: Group D (n = 129) received 12.5 mg dolasetron i.v., Group MCP (n = 129) 20 mg MCP i.v., and Group C (n = 129) saline as placebo i.v. Using a multifactorial study design, one third of each main group (n = 43) was further randomized to receive either general anesthesia with desflurane, isoflurane or IVA with propofol and remifentanil. PONV, postoperative piritramide and droperidol consumption were documented. RESULTS: Independent from the anesthesia regimen chosen, dolasetron reduced PONV (19%) significantly compared to MCP (45%) and placebo (46%). Furthermore we could show a significant difference in the incidence of PONV between IVA (28%) and isoflurane (46%), but not in comparison to desflurane (36%). Patients receiving IVA had a higher postoperative piritramide consumption compared to the two other groups. CONCLUSIONS: The results of our study suggest that dolasetron was more effective than MCP and placebo in preventing PONV. This action is independent of the anesthetic technique used.     

Ondansetron compared with metoclopramide in the treatment of established postoperative nausea and vomiting

We have studied 746 males and females undergoing general anaesthesia for any type of surgical procedure in a double-blind, controlled, randomized study. After experiencing at least one nausea and/or one emetic episode in the 6 h after recovery from anaesthesia, patients received either ondansetron 4 mg i.v. or metoclopramide 10 mg i.v. Patients were observed for postoperative nausea and vomiting (PONV) for 24 h after drug administration. Complete control of PONV was achieved more frequently in the ondansetron-treated patients compared with the metoclopramide-treated patients during the 24-h period (59% vs 41% (P < 0.001) and 44% vs 34% (P = 0.006) for emetic episodes and nausea, respectively). Furthermore, ondansetron was associated with greater patient satisfaction than metoclopramide (P < 0.001) with 49% and 32% of patients, respectively, very satisfied. The overall incidence of adverse events was similar in the ondansetron (7%) and metoclopramide (8%) groups. Ondansetron was as well tolerated and more effective than metoclopramide for all assessment criteria in the treatment of established PONV.      

Ondansetron or droperidol for prophylaxis of nausea and vomiting after intrathecal morphine

BACKGROUND AND OBJECTIVE: There is a controversy regarding the best drug for prevention of nausea and vomiting in patients receiving intrathecal morphine. The aim of this study was to examine efficacy and tolerability of droperidol compared with ondansetron for the prevention of morphine-induced nausea and vomiting. METHODS: In a randomized, placebo-controlled trial, 120 women undergoing Caesarean section under spinal anaesthesia with intrathecal morphine 0.1 mg received intravenous ondansetron 4 mg (n = 40), droperidol 1.25 mg (n = 40) or saline (n = 40) immediately after umbilical-cord clamping. Nausea and vomiting were graded according to intensity at 1, 2, 4, 6, 12 and 24 h. RESULTS: Nausea or vomiting occurred in 14 patients (35%) in the placebo group, 4 (10%) in the ondansetron group and 10 (25%) in the droperidol group; the difference between ondansetron and placebo was statistically significant (P = 0.007). Eleven of the 14 placebo patients (27.5%) vomited, compared with none of the 4 ondansetron patients (vs. placebo, P = 0.0004) and 5 of the droperidol patients (vs. placebo, P = 0.18). Three of the 14 placebo patients (7.5%) were nauseous, compared with 4 (10%) receiving ondansetron and 5 (12.5%) receiving droperidol. CONCLUSIONS: Ondansetron was effective in reducing the incidence of nausea and vomiting in patients receiving intrathecal morphine for Caesarean section.     

Prevention of postoperative nausea and vomiting by domperidone: A double-blind randomized study using domperidone, metoclopramide and a placebo.

One hundred and ninety-five female patients of child-bearing age were assessed for postoperative vomiting in a double-blind trial using domperidone, metoclopramide and placebo. Compared with placebo, both drugs were found to reduce vomiting in approximately half the patients who had undergone caesarean section. However, in the group of non-obstetric patients, no statistically significant difference as regards vomiting was shown.