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NOT YET RECRUITING
NCT07088601
PHASE4

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

Sponsor: Cairo University

View on ClinicalTrials.gov

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.

Official title: Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering; a Double Blinded, Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-08-10

Completion Date

2025-12-29

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DRUG

Oral ondansetron strips

In the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group O will receive oral ondansetron in the form of an oral soluble film 4 mg strip.

OTHER

Placebo (oral peppermint strip)

In the anesthesia preparation room and before the insertion of the peripheral IV cannula, patients in group C will receive a placebo in the form of an oral peppermint strip.