Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery

Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery

Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Nausea, Postoperative; Vomiting, Postoperative; Patient Reported Outcomes; Antiemetics
• Intervention / Treatment: Procedure: Laparoscopic sleeve gastrectomy; Drug: Ondansetron 1 mg/kg, max dose 8 mg; Drug: Palonosetron 1mcg/kg

Detailed Description

Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bagcılar Training and Research Hospital
  • Istanbul, Turkey
    • Surp Pırgic Armenian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

obese patients underwent laparoscopic sleeve gastrectomy

Description

Inclusion Criteria:

• All morbidity obese patients underwent laparoscopic sleeve gastrectomy

Exclusion Criteria:

drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ondansetron; In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.	Procedure: Laparoscopic sleeve gastrectomy; Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape; Drug: Ondansetron 1 mg/kg, max dose 8 mg; Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.
Palonosetron; The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.	Procedure: Laparoscopic sleeve gastrectomy; Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape; Drug: Palonosetron 1mcg/kg; Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nause and vomiting 6hr	Visual Analog Scale score for nausea and vomiting	postoperative 6 hours
Nause and vomiting 24hr	Visual Analog Scale score for nausea and vomiting	postoperative 24 hours
Nause and vomiting 48hr	Visual Analog Scale score for nausea and vomiting	postoperative 48 hours
Nause and vomiting 72hr	Visual Analog Scale score for nausea and vomiting	postoperative 72 hours
amount of rescue anti-emetic drugs	Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.	postoperative seventh day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain 6hr	Visual Analog Scale score for pain	postoperative 6 hours
Pain 24hr	Visual Analog Scale score for pain	postoperative 24 hours
Pain 48hr	Visual Analog Scale score for pain	postoperative 48 hours
Pain 72hr	Visual Analog Scale score for pain	postoperative 72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional living index- Emesis	Quality of life after discharge about emesis using Functional living index- Emesis	postoperative seventh day

Collaborators and Investigators

• Sponsor: Bagcilar Training and Research Hospital
• Investigators: Study Director: Ali Solmaz, Ass. Prof., Private Camlıca Erdem Hospital/Istanbul-TURKEY

Publications and helpful links

General Publications

• Aydin A, Kacmaz M, Boyaci A. Comparison of ondansetron, tropisetron, and palonosetron for the prevention of postoperative nausea and vomiting after middle ear surgery. Curr Ther Res Clin Exp. 2019 Jun 22;91:17-21. doi: 10.1016/j.curtheres.2019.06.002. eCollection 2019.
• Lee S, Kim I, Pyeon T, Lee S, Song J, Rhee J, Jeong S. Population pharmacokinetics of palonosetron and model-based assessment of dosing strategies. J Anesth. 2019 Jun;33(3):381-389. doi: 10.1007/s00540-019-02641-5. Epub 2019 Apr 11.
• Rajnikant K, Bhukal I, Kaloria N, Soni SL, Kajal K. Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy. Anesth Essays Res. 2019 Apr-Jun;13(2):317-322. doi: 10.4103/aer.AER_21_19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2020
• Primary Completion (ACTUAL): December 15, 2020
• Study Completion (ACTUAL): January 1, 2021

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (ACTUAL): September 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Palonosetron; Ondansetron
• Other Study ID Numbers: Beren Hacım 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No