Clinical Trial

Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering

Study acronym: OOPS
Not Yet Recruiting Phase 4
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Record status
This record was last updated July 30, 2025 (before its estimated December 29, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to investigate the efficacy of oral ondansetron film strips on the incidence of post-spinal shivering in patients undergoing surgeries using spinal anesthesia at Kasr Alainy hospitals, Cairo University. This prospective, double-blinded, randomized controlled study will be conducted on 50 patients aged from 18 to 65 years of both sexes with ASA I, II who are scheduled for elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries. Patients will be divided into two equal groups: Group (O) will receive oral ondansetron in the form of an oral soluble film 4 mg strip immediately before insertion of IV cannula and group (C) will receive a placebo in the form of an oral peppermint strip immediately before insertion of the IV cannula.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-19.
Trial Details
NCT Number NCT07088601
Lead Sponsor Cairo University
Conditions Post-Spinal Shivering
Enrollment 50 participants
Start Date 2025-08-10
Primary Completion 2025-12-29 (estimated)
Study Completion 2025-12-29 (estimated)
Updated on ClinicalTrials.gov 2025-07-30