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Prophylaxis with Oral Granisetron for the Prevention of Nausea and Vomiting After Laparoscopic Cholecystectomy a Prospective Randomized Study

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Prophylaxis with Oral Granisetron for the Prevention of Nausea and Vomiting After Laparoscopic Cholecystectomy a Prospective Randomized Study ORIGINAL ARTICLE Prophylaxis With Oral Granisetron for the Prevention of Nausea and Vomiting After Laparoscopic Cholecystectomy A Prospective Randomized Study Yoshitaka Fujii, MD; Hiroyoshi Tanaka, MD; Tsuneo Kawasaki, MD Hypothesis: Laparoscopic cholecystectomy is associ- dard general anesthetic technique and postoperative ated with a relatively high incidence of postoperative nau- analgesia were used. sea and vomiting when no prophylactic antiemetic is given. This study assesses the efficacy and safety of oral Main Outcome Measures: Emetic episodes were re- granisetron hydrochloride for the prevention of nausea corded during the first 24 hours after anesthesia. and vomiting after laparoscopic cholecystectomy. Results: The incidence of patients who were emesis- Design: A prospective, randomized, double-blind, pla- free 24 hours after anesthesia was 60% with 1 mg of granise- cebo-controlled study. tron (P=.40), 83% with 2 mg of granisetron (P=.01), and 83% with 4 mg of granisetron (P=.01), compared with Setting: University teaching hospital. placebo (53%). No clinically important adverse effects were observed in any of the groups. Patients: The study comprised 120 patients, 92 women and 28 men, undergoing laparoscopic cholecystectomy. Conclusion: Preoperative oral granisetron in doses higher than 2 mg is effective for the prevention of nausea and Interventions: Patients received orally either placebo vomiting after laparoscopic cholecystectomy. or granisetron at 3 different doses (1 mg, 2 mg, and 4 mg; n=30 of each) 60 minutes before surgery. A stan- Arch Surg. 2001;136:101-104 HE REPORTED incidence of tron reduces the incidence of postopera- nausea and vomiting after tive nausea and vomiting in patients un- laparoscopic cholecystec- dergoing laparoscopic cholecystectomy.7 tomy with no antiemetic However, granisetron ($33.40 for 1 mg) and treatment varies from 25% ondansetron ($33.43 for 1 mg) are much Tto 42%.1,2 A variety of pharmacological ap- more expensive than other commonly used proaches (antihistamines, butyrophe- well-established antiemetics, such as dro- nones, dopamine receptor antagonists) peridol ($1.80 for 2.5 mg) and metoclop- have been investigated for the preven- ramide hydrochloride ($0.60 for 10 mg). tion and treatment of postoperative nau- In our institution, this may delay wide- sea and vomiting, but adverse effects such spread use as an antiemetic. An oral granis- as excessive sedation, hypotension, dry etron preparation ($12.60 for 1 mg) that mouth, dysphoria, hallucinations, and ex- is less expensive and is effective for reduc- trapyramidal signs have been noted.3 On- ing emesis caused by cancer chemo- dansetron hydrochloride, a serotonin type therapy is now available.8 The purpose of 3 receptor antagonist, reduces the inci- this study was to evaluate the efficacy and dence of nausea and vomiting after gyne- safety of prophylaxis with oral granise- cologic surgery.4 Granisetron hydrochlo- tron for the prevention of nausea and vom- ride, another antagonist of serotonin iting after laparoscopic cholecystectomy. receptors, is effective for the treatment of From the Departments of emesis in patients receiving cytotoxic RESULTS Anesthesiology (Drs Fujii and 5 Tanaka) and Surgery drugs. Granisetron is more potent and has (Dr Kawasaki), Toride Kyodo longer-acting properties against cisplatin- Six women and 4 men were excluded from General Hospital, Toride City, induced emesis than ondansetron.6 We the study, according to the exclusion cri- Ibaraki, Japan. have recently demonstrated that granise- teria. Patient profile and information on (REPRINTED) ARCH SURG/ VOL 136, JAN 2001 WWW.ARCHSURG.COM 101 ©2001 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 PATIENTS, MATERIALS, isoflurane and nitrous oxide administration was stopped. Residual neuromuscular blockade was antagonized with AND METHODS IV atropine sulfate at 0.02 mg/kg and IV neostigmine methylsulfate at 0.04 mg/kg, and then the trachea was After obtaining institutional review board approval and extubated. Rectal temperature was monitored and main- informed consent from each patient, we studied 130 tained at 37°C±1°C using a heating pad throughout patients who were classified as physical status 1 according surgery. Postoperatively, all patients were admitted to the to the American Society of Anesthesiologists. The group hospital for 2 days. Postoperative analgesia was provided was composed of 98 women and 32 men, between 25 and rectally with indomethacin at 50 mg for moderate pain 63 years old, undergoing general anesthesia for elective and intramuscularly with pentazocine hydrochloride at 15 laparoscopic cholecystectomy. Indications for this surgi- mg for severe pain. cal procedure in the current clinical trial are symptomatic Postoperatively, emetic episodes during the first 24 cholelithiasis, chronic cholecystitis, and cholecystic hours after anesthesia were recorded by nursing staff polyp. Exclusion criteria were antiemetics given within 24 blind to which treatment the patients had received. The hours before surgery; active, acute cholecystitis in the 6 nurses asked the patients if retching or vomiting had months prior to admission; regular corticosteroid therapy; occurred and if they felt nauseated. These nurses observed serum g-glutamyltransferase, alkaline phosphatase, or the patients at various intervals according to the normal direct bilirubin levels twice normal; or laparoscopy ward routine. Nausea was defined as the subjectively replaced by laparotomy. Patients were randomly allo- unpleasant sensation associated with awareness of the cated via a computer-generated random numbers list to urge to vomit; retching was defined as the labored, spas- receive 1 of 4 treatment regimens (n=30 of each): modic, rhythmic contraction of the respiratory muscles granisetron at 3 different doses (1 mg, 2 mg, or 4 mg) or without the expulsion of gastric content; and vomiting placebo. These drugs were given orally 60 minutes was defined as the forceful expulsion of gastric contents before surgery. Identical-looking tablets containing from the mouth.3 The details of any adverse effects were either placebo, 1 mg of granisetron, 2 mg of granisetron, noted throughout the study, whether obtained through or 4 mg of granisetron were prepared according to ran- general questioning of the patients by follow-up nurses, domization. through observation by these nurses, or spontaneously No patients received preanesthetic medication. Anes- mentioned by the patients. thesia was induced intravenously (IV) with thiopentone Patient demographic data were determined by analy- sodium at 5 mg/kg and fentanyl citrate at 2 µg/kg, and IV sis of variance with the Bonferroni adjustment for mul- vecuronium bromide at 0.2 mg/kg was used to facilitate tiple comparison or x2 test. The number of patients who tracheal intubation. After intubation of the trachea, anes- were emesis-free or experiencing nausea, retching, or vom- thesia was maintained with isoflurane at 1.0% to 3.0% iting and the incidence of adverse effects were compared (inspired concentration) and nitrous oxide at 66% in oxy- with the Fisher exact probability test. A P value less than gen, with controlled ventilation adjusted to maintain an .05 was considered significant. All values were expressed end-tidal carbon dioxide concentration between 35 and as mean (SD) or number (percentage). Power analysis was 40 mm Hg using an anesthetic/respiratory gas analyzer used to determine the number of patients in the current (Ultima; Datex, Helsinki, Finland). A nasogastric tube study based on the assumptions that the incidence of an was inserted, and suction was applied to empty the stom- emetic-free period (which was regarded as the primary end- ach of air and other contents. Before extubation of the tra- point) in patients receiving placebo would be 50%, an im- chea, the nasogastric tube was again suctioned and then provement between 50% and 80% was considered of clini- removed. Neuromuscular block was achieved with cal importance, and a=.05 and 1 − b=.8. Based on these vecuronium. At the completion of the surgical procedure, assumptions, 30 patients per group were required. surgery and anesthesia are summarized in Table 1. There COMMENT were no differences in patient demographics among the treatment groups. No differences were observed with Patients undergoing elective laparoscopic cholecystec- regard to the number of patients with either nausea, tomy have a relatively high incidence of postoperative retching, or vomiting. The only difference was found in nausea and vomiting.1,2 This problem is multifactorial the incidence of patients who were emesis-free up to 24 in origin, including patient demographics, nature of hours after anesthesia, which occurred in 16 (53%), 18 the underlying disease, type of surgery, anesthetic (60%), 25 (83%), and 25 (83%) of 30 patients who had technique, and postoperative care.3 The main patient- received placebo, 1 mg of granisetron, 2 mg of granis- related factors are age, sex, obesity, menstrual cycle, etron, and 4 mg of granisetron, respectively. Thus, an and history of motion sickness and/or previous post- emesis-free period was more common in patients who operative nausea and vomiting. Surgical factors had received granisetron at either 2 mg or 4 mg than in include the effect of intraperitoneal carbon dioxide those who had received placebo (P,.05). However, insufflation on residual stretching and irritation of the there was no difference
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