Antiemetic Efficacy for Laparoscopic Sleeve Gastrectomy
The CONSORT guidelines were followed in this study [9 (link)]. The Enrolled patients were randomized using permuted block randomization technique with software-generated blocks. According to the blocks, the patients were sequentially called for elective surgery (Fig. 1). After performing the operation, we randomly placed the pre-written order sheets in the patients' files. This action was performed by a research coordinator who was not involved in the study (usually PGY-1 residents). All the surgery team was unaware of the type of antiemetic used for the PONV. The conventional laparoscopic sleeve gastrectomy (LSG) was performed for all the patients using the above-mentioned guidelines.
The Enrollment Flow Chart of the Patients (CONSORT). GA Granisetron only group, MA Metoclopramide only group, OA Ondansetron only group, MO group received both ondansetron and metoclopramide
Every patient received intravenous (IV) proton-pump inhibitor (pantoprazole 20 mg) and subdermal Enoxaparin (weight-based dosage adjusted [10 (link)]) for each day postoperatively. After the surgery, PONV was measured within the first 2 days in the mornings and evenings using a simplified PONV impact scale questionnaire [11 (link)]. The episodes of both nausea and vomiting were recorded. Scores equal to or more than one were considered positive for both nausea and vomiting. Also, If the sum of the two scores was greater than 4, it would be regarded as clinically significant, and the rescue antiemetic was initiated for the patient (Fig. 2).
A copy of Simplified PONV impact scale used to measure the incidence of PONV. It should be noted that we used a persian copy of this questionnaire
All the patients underwent ERAS protocols (Fig. 3). Furthermore, In cases where the patient had developed PONV (including Group 1), IV Metoclopramide 0.2 mg (immediately, without delay [STAT], and twice a day [BiD]) was used as a rescue antiemetic (rescue regimen was only used in patients who failed to prevent PONV, and was not a usual part of ERAS).
Study stages showed as a flowchart. *Body Mass Index. **Patients who underwent concurrent intrabdominal operations were not included. ***Gastroesophageal Reflux Disease. †Sleeve Gastrectomy. ††Enhanced Recovery After Surgery (has been described in details below the methods section)
We only studied the rate of PONV during the admission days, and did not evaluate the incidence of nausea or vomiting after discharge. This is due to the high rate of PONV after the surgery within the first days. For the reduction of the incidence of bias and confounding factors, all used anesthetics and antiemetics were provided from the same brand for each drug (see Appendix).
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Ebrahimian M., Mirhashemi S.H., Oshidari B., Zamani A., Shadidi-Asil R., Kialashaki M, & Ghayebi N. (2023). Effects of ondansetron, metoclopramide and granisetron on perioperative nausea and vomiting in patients undergone bariatric surgery: a randomized clinical trial. Surgical Endoscopy, 37(6), 4495-4504.
Antiemetic used for PONV (Granisetron, Metoclopramide, Ondansetron, or Ondansetron and Metoclopramide)
dependent variables
Incidence of PONV (nausea and vomiting) within the first 2 days after surgery, measured using a simplified PONV impact scale questionnaire
control variables
All patients underwent the same surgical procedure (conventional laparoscopic sleeve gastrectomy)
All patients received the same postoperative treatments (intravenous proton-pump inhibitor, subdermal Enoxaparin)
All patients underwent ERAS protocols
All used anesthetics and antiemetics were provided from the same brand for each drug
positive controls
Patients who developed PONV (including Group 1) received intravenous Metoclopramide 0.2 mg as a rescue antiemetic
negative controls
Not applicable
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