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

Study acronym: OOPS
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Minor Secondary endpoints: details revised at 2 of 7 entries
    • Study title shortened, about 6 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07088601
Lead Sponsor Cairo University
Conditions
(from sponsor)
Post-Spinal Shivering
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov