Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery

NCT05087615 | Completed Phase 3 DMC

• 1 other identifier: ManoochehrEbrahimian
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative nausea and vomiting (PONV) is one of the leading causes of patient morbidity after laparoscopic bariatric surgeries. A wide variety of complications related to PONV has been described, such as prolonged length of stay (LOS) in hospital, unnecessary readmissions, delay in oral intake, and bad experience for patients. Although several antiemetic regimens have been tried so far in different studies, the incidence of PONV is not significantly lowered, and it seems that it is impossible to totally eliminate it. On the other hand, the implementation of Enhanced Recovery After Surgery (ERAS) has greatly reduced the incidence of PONV and LOS. Therefore, a combination of ERAS and multiple antiemetic regimens is currently used to reduce the incidence of PONV. Nevertheless, the optimal regimen has not been found yet, and many trials are conducting to find out the best antiemetic regimen. In this randomized clinical trial, we compare four different combined and single regimens alongside the implementation of ERAS to show which regimen is more effective.

Conditions

Bariatric Surgery Candidate; Perioperative Complication; Nausea; Vomiting, Postoperative; Drug Effect

Keywords

Bariatric Surgery; Post-operative nausea or vomiting; Sleeve Gastrectomy; Ondansetron; Metoclopramide; Granisetron

Outcome Measures

Primary Outcomes (1)

• Change PONV

  reduction in the incidence of postoperative nausea/vomiting

  PONV has been measured in day one, and two of admission

Study Arms (5)

Control

NO INTERVENTION

Patients who did not receive any antiemetic during hospitalization (NA).

MA

EXPERIMENTAL

Patients receiving metoclopramide alone (MA).

Drug: Metoclopramide

OA

EXPERIMENTAL

Patients who received ondansetron only (OA).

Drug: Ondansetron

MO

EXPERIMENTAL

Patients receiving a combination of metoclopramide and ondansetron (MO).

Drug: Metoclopramide and Ondanteron

GA

EXPERIMENTAL

Patients who received granisetron alone (GA).

Drug: Granisetron

Interventions

Metoclopramide DRUG

This groups only received metoclopramide 0.2 mg/kg IV Bid as antiemetic in the postoperative period.

Also known as: Plasil

MA

Ondansetron DRUG

This groups only received ondansetron 8 mg IV Bid as antiemetic in the postoperative period.

OA

Metoclopramide and Ondanteron DRUG

This groups received both metoclopramide 0.2 mg IV Bid and ondansetron 8 mg IV/Bid as antiemetics in the postoperative period.

MO

Granisetron DRUG

This groups only received granisetron 2 mg IV Bid as antiemetic in the postoperative period.

GA

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI\>40
• Only bariatric operations
• mild or moderate surgical risk
• without any previous gastrointestinal problems
• no previous gastrointestinal surgery

You may not qualify if:

• Moderate or severe gastritis or duodenitis
• GERD
• lack of H. Pylori eradication
• concurrent cholecystectomy
• Dissatisfaction during study

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Loghman Hakim Hospital

Tehran, 0, Iran

Location

Related Publications (4)

• Naeem Z, Chen IL, Pryor AD, Docimo S, Gan TJ, Spaniolas K. Antiemetic Prophylaxis and Anesthetic Approaches to Reduce Postoperative Nausea and Vomiting in Bariatric Surgery Patients: a Systematic Review. Obes Surg. 2020 Aug;30(8):3188-3200. doi: 10.1007/s11695-020-04683-1.

  PMID: 32415635 BACKGROUND

• Therneau IW, Martin EE, Sprung J, Kellogg TA, Schroeder DR, Weingarten TN. The Role of Aprepitant in Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery. Obes Surg. 2018 Jan;28(1):37-43. doi: 10.1007/s11695-017-2797-0.

  PMID: 28674839 BACKGROUND

• Fathy M, Abdel-Razik MA, Elshobaky A, Emile SH, El-Rahmawy G, Farid A, Elbanna HG. Impact of Pyloric Injection of Magnesium Sulfate-Lidocaine Mixture on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy: a Randomized-Controlled Trial. Obes Surg. 2019 May;29(5):1614-1623. doi: 10.1007/s11695-019-03762-2.

  PMID: 30734195 BACKGROUND

• Moussa AA, Oregan PJ. Prevention of postoperative nausea and vomiting in patients undergoing laparoscopic bariatric surgery--granisetron alone vs granisetron combined with dexamethasone/droperidol. Middle East J Anaesthesiol. 2007 Jun;19(2):357-67.

  PMID: 17684876 BACKGROUND

MeSH Terms

Conditions

Nausea; Postoperative Nausea and Vomiting; Vomiting

Interventions

Metoclopramide; Ondansetron; Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Azabicyclo Compounds; Aza Compounds; Indazoles; Pyrazoles; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: After taking informed consent, patients enrolled in the groups. Each group had 26 members, and the subjects were unaware of which group they had been assigned. Also, the investigators weren't aware of the treatment assignment until the end of the trial.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: the patients were divided into five parallel groups including control and study groups. Group 1: Patients who did not receive any antiemetic during hospitalization (NA). Group 2: Patients receiving metoclopramide alone (MA). Group 3: Patients who received ondansetron only. (OA) Group 4: Patients receiving a combination of metoclopramide and ondansetron (MO). Group 5: Patients who received granisetron alone (GA).

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: March 1, 2021
• Primary Completion: August 21, 2021
• Study Completion: September 6, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from February 2022
• Access Criteria: Everyone with verified institutional email.

Locations

IR (1)