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

NCT ID: NCT05087615

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-09-06

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.

Detailed Description

After being approved by Iran National Committee for Ethics in Biomedical Research (IR.SBMU.MSP.REC.1399.784), a randomized clinical controlled trial was started with 130 patients in five groups. All the patients were proper candidates for laparoscopic bariatric surgeries, and structured informed consent was obtained from all participants.

All the operations were performed by board certified advanced laparoscopic surgeons in a minimally invasive educational center. All bariatric surgery was performed in our standardized institutional protocols as well as preoperative and postoperative care. Sleeve Gastrectomy (SG) surgeries were performed by using 44Fr Tubes.

To calculate the sample size in the clinical trial, we used the ANCOVA method with web-based tools. Twenty-six patients were estimated for each group. Patients were divided into five 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). All patients were undergone ERAS protocols. In cases where the patient had PONV (including Group 1), intravenous Metoclopramide 0.2mg (Stat and BiD) was used as a rescue antiemetic.

To reduce the incidence of bias and confounding factors, all anesthetics and antiemetics used were provided from the same brand for each drug (see Appendix).

Patients with severe or moderate gastritis or duodenitis on esophagogastroduodenoscopy were excluded from the study, but patients with mild gastritis or positive rapid urease test on endoscopy, were treated for two weeks with three drugs of pentazole, amoxicillin, and metronidazole, and if the respiratory urease test was negative, they were included in the study and in refractory cases of H. Pylori, they were excluded. According to the American Society of Anesthesiologists (ASA) classification, patients with severe respiratory or cardiovascular problems (ASA III or higher) or a history of gastric or small bowel surgery were also excluded. Patients who underwent simultaneous cholecystectomy with bariatric surgery were also excluded.

Conditions

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

MA

Patients receiving metoclopramide alone (MA).

Group Type: EXPERIMENTAL

Metoclopramide

Intervention Type: DRUG

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

OA

Patients who received ondansetron only (OA).

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

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

MO

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

Group Type: EXPERIMENTAL

Metoclopramide and Ondanteron

Intervention Type: DRUG

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

GA

Patients who received granisetron alone (GA).

Group Type: EXPERIMENTAL

Granisetron

Intervention Type: DRUG

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

Interventions

Metoclopramide

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

Intervention Type: DRUG

Ondansetron

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

Intervention Type: DRUG

Metoclopramide and Ondanteron

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

Intervention Type: DRUG

Granisetron

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

Intervention Type: DRUG

Other Intervention Names

Plasil

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Manoochehr Ebrahimian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Loghman Hakim Hospital

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: BACKGROUND

PMID: 32415635 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28674839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30734195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17684876 (View on PubMed)

Other Identifiers

ManoochehrEbrahimian

Identifier Type: -

Identifier Source: org_study_id