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

NCT04533867 | Completed FDA Drug

• 1 other identifier: Beren Hacım 3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nausea, Postoperative; Vomiting, Postoperative; Patient Reported Outcomes; Pain, Postoperative; Antiemetics

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Pain 6hr

  postoperative 6 hours

• Pain 24hr

  postoperative 24 hours

• Pain 48hr

  postoperative 48 hours

• Pain 72hr

  postoperative 72 hours

Other Outcomes (1)

• Functional living index- Emesis

  postoperative seventh day

Study Arms (2)

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; Drug: Ondansetron 1 mg/kg, max dose 8 mg

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; Drug: Palonosetron 1mcg/kg

Interventions

Laparoscopic sleeve gastrectomy PROCEDURE

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

Ondansetron; Palonosetron

Palonosetron 1mcg/kg DRUG

Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.

Palonosetron

Ondansetron 1 mg/kg, max dose 8 mg DRUG

Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.

Ondansetron

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: between 18-65 years
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

obese patients underwent laparoscopic sleeve gastrectomy

You may qualify if:

• All morbidity obese patients underwent laparoscopic sleeve gastrectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (2)

Bagcılar Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Surp Pırgic Armenian Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31384338 RESULT

• 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.

  PMID: 30976908 RESULT

• 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.

  PMID: 31198253 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Palonosetron; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Ali Solmaz, Ass. Prof.

  Private Camlıca Erdem Hospital/Istanbul-TURKEY

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pirincipal investigator Adnan

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: September 1, 2020
• Study Start: August 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 1, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

TU (2)