Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering (NCT07088601) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Efficacy of Oral Ondansetron Strips on Prevention of Post-Spinal Shivering
50 participantsStarted 2025-08-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* American Society of Anesthesiologists (ASA) physical status I, II.
* Patients underwent elective surgical procedures under spinal anesthesia in the lower half of the body such as orthopedic, urological, or general surgeries.
Exclusion Criteria:
* Patient refusal.
* Morbid obese patients or those who were not candidates for spinal anesthesia.
* Pregnant females.
* Patients with comorbidities such as severe cardiopulmonary, severe hepatic or renal diseases, thyroid disorders, and convulsions.
* Uncooperative patients and patients with psychological disorders.
* Patients on regular ondansetron or other antiemetics.
* Patients taking selective serotonin reuptake inhibitors.
* Patients with allergy to 5-HT3 receptor antagonist drugs.
* Patients receiving saddle spinal block.
* In surgeries less than 1 h or longer than 3 hours duration.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of shivering.
Timeframe: starting from 15 minutes after lumber puncture until 180 minutes following it and postoperative.