Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery
Condition: Bariatric Surgery Candidate; Perioperative Complication; Nausea; Vomiting, Postoperative; Drug Effect
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Metoclopramide; Ondansetron; Metoclopramide and Ondanteron; Granisetron
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): This groups only received metoclopramide 0.2 mg/kg IV Bid as antiemetic in the postoperative period.; This groups only received ondansetron 8 mg IV Bid as antiemetic in the postoperative period.; This groups received both metoclopramide 0.2 mg IV Bid and ondansetron 8 mg IV/Bid as antiemetics in the postoperative period.; This groups only received granisetron 2 mg IV Bid as antiemetic in the postoperative period.
Other intervention name(s): Plasil
Intervention MeSH terms: Ondansetron; Metoclopramide; Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Bariatric Surgery; Post-operative nausea or vomiting; Sleeve Gastrectomy; Ondansetron; Metoclopramide; Granisetron