Clinical trial NCT04533867: Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery
Official title: Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nausea, Postoperative
Vomiting, Postoperative
Patient Reported Outcomes
Pain, Postoperative
Antiemetics
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obese patients underwent laparoscopic sleeve gastrectomy

Brief summary: Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.

Detailed description: Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.

Eligibility criteria: Inclusion Criteria:

* All morbidity obese patients underwent laparoscopic sleeve gastrectomy

Exclusion Criteria:

drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.

Primary outcomes:
measure: Nause and vomiting 6hr
timeFrame: postoperative 6 hours
measure: Nause and vomiting 24hr
timeFrame: postoperative 24 hours
measure: Nause and vomiting 48hr
timeFrame: postoperative 48 hours
measure: Nause and vomiting 72hr
timeFrame: postoperative 72 hours
measure: amount of rescue anti-emetic drugs
timeFrame: postoperative seventh day
Secondary outcomes:
measure: Pain 6hr
timeFrame: postoperative 6 hours
measure: Pain 24hr
timeFrame: postoperative 24 hours
measure: Pain 48hr
timeFrame: postoperative 48 hours
measure: Pain 72hr
timeFrame: postoperative 72 hours
Other outcomes:
measure: Functional living index- Emesis
timeFrame: postoperative seventh day
Locations:
city: Istanbul
country: Turkey
facility: Bagcılar Training and Research Hospital
city: Istanbul
country: Turkey
facility: Surp Pırgic Armenian Hospital
Study officials:
affiliation: Private Camlıca Erdem Hospital/Istanbul-TURKEY
name: Ali Solmaz, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: Aydin A, Kacmaz M, Boyaci A. Comparison of ondansetron, tropisetron, and palonosetron for the prevention of postoperative nausea and vomiting after middle ear surgery. Curr Ther Res Clin Exp. 2019 Jun 22;91:17-21. doi: 10.1016/j.curtheres.2019.06.002. eCollection 2019.
citation: Lee S, Kim I, Pyeon T, Lee S, Song J, Rhee J, Jeong S. Population pharmacokinetics of palonosetron and model-based assessment of dosing strategies. J Anesth. 2019 Jun;33(3):381-389. doi: 10.1007/s00540-019-02641-5. Epub 2019 Apr 11.
citation: Rajnikant K, Bhukal I, Kaloria N, Soni SL, Kajal K. Comparison of Palonosetron and Dexamethasone with Ondansetron and Dexamethasone to Prevent Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy. Anesth Essays Res. 2019 Apr-Jun;13(2):317-322. doi: 10.4103/aer.AER_21_19.