Clinical trial NCT05087615: Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery
Official title: Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bariatric Surgery Candidate
Perioperative Complication
Nausea
Vomiting, Postoperative
Drug Effect
Keywords: Bariatric Surgery
Post-operative nausea or vomiting
Sleeve Gastrectomy
Ondansetron
Metoclopramide
Granisetron
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 130
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change PONV
timeFrame: PONV has been measured in day one, and two of admission
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Loghman Hakim Hospital
Study officials:
References:
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.
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.
citation: 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.
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.