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

Bariatric Surgery Candidate Clinical Trial

— PONV  

Official title:

Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087615
• Other study ID #: ManoochehrEbrahimian
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2021
• Est. completion date: September 6, 2021

Study information

• Verified date: October 2021
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 6, 2021
• Est. primary completion date: August 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Drug Effect
• Nausea
• Perioperative Complication
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

Drug:
• Metoclopramide
This groups only received metoclopramide 0.2 mg/kg IV Bid as antiemetic in the postoperative period.
• Ondansetron
This groups only received ondansetron 8 mg IV Bid as antiemetic in the postoperative period.
• 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.
• Granisetron
This groups only received granisetron 2 mg IV Bid as antiemetic in the postoperative period.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Loghman Hakim Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Erratum in: Obes Surg. 2019 Feb 11;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change PONV	reduction in the incidence of postoperative nausea/vomiting	PONV has been measured in day one, and two of admission