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Palonosetron vs. Ondansetron for Postoperative Nausea and Vomiting in Bariatric Surgery

NCT04533867 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-01-22

No results posted yet for this study

Summary

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

Conditions

  • Nausea, Postoperative
  • Vomiting, Postoperative
  • Patient Reported Outcomes
  • Pain, Postoperative
  • Antiemetics

Interventions

PROCEDURE

Laparoscopic sleeve gastrectomy

Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape

DRUG

Palonosetron 1mcg/kg

Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.

DRUG

Ondansetron 1 mg/kg, max dose 8 mg

Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.

Sponsors & Collaborators

  • Bagcilar Training and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Ali Solmaz, Ass. Prof. · Private Camlıca Erdem Hospital/Istanbul-TURKEY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2020-12-15
Completion
2021-01-01
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533867 on ClinicalTrials.gov