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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533867
• Other study ID #: Beren Hacim 3
• Status: Completed
• Start date: August 15, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2021
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: December 15, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antiemetics
• Nausea
• Nausea, Postoperative
• Pain, Postoperative
• Patient Reported Outcomes
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Bagcilar Training and Research Hospital	Istanbul
Turkey	Surp Pirgic Armenian Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Aydin A, Kaçmaz 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. eCo — View Citation

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. — View Citation

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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional living index- Emesis	Quality of life after discharge about emesis using Functional living index- Emesis	postoperative seventh day
Primary	Nause and vomiting 6hr	Visual Analog Scale score for nausea and vomiting	postoperative 6 hours
Primary	Nause and vomiting 24hr	Visual Analog Scale score for nausea and vomiting	postoperative 24 hours
Primary	Nause and vomiting 48hr	Visual Analog Scale score for nausea and vomiting	postoperative 48 hours
Primary	Nause and vomiting 72hr	Visual Analog Scale score for nausea and vomiting	postoperative 72 hours
Primary	amount of rescue anti-emetic drugs	Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.	postoperative seventh day
Secondary	Pain 6hr	Visual Analog Scale score for pain	postoperative 6 hours
Secondary	Pain 24hr	Visual Analog Scale score for pain	postoperative 24 hours
Secondary	Pain 48hr	Visual Analog Scale score for pain	postoperative 48 hours
Secondary	Pain 72hr	Visual Analog Scale score for pain	postoperative 72 hours