Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering (NCT07334223) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering
Pakistan180 participantsStarted 2020-01-01
Plain-language summary
This randomized controlled trial assessed whether intravenous ondansetron is more effective than low dose ketamine in preventing shivering after spinal anesthesia in adults undergoing elective surgery. Post spinal shivering is a frequent and uncomfortable complication of spinal anesthesia and may increase oxygen demand and interfere with routine monitoring. Adults aged 20 to 70 years (body weight 50 to 80 kg; American Society of Anesthesiologists class I to II) scheduled for elective procedures under standardized spinal anesthesia were randomly allocated in equal numbers to receive either ondansetron 8 mg intravenously or ketamine 0.25 mg/kg intravenously, administered 5 minutes after the spinal injection. Perioperative temperature management was standardized for all participants. The primary outcome was the occurrence of post spinal shivering during intraoperative monitoring. Among 180 participants, shivering occurred in 30.0% of those receiving ondansetron and 44.4% of those receiving ketamine, showing a statistically significant reduction with ondansetron.
Who can participate
Age range
20 Years – 70 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:
* Patients of either gender aged 20-60 years with ideal body
* weight of 50 to 80 kg.
* Patients meeting ASA classification I and II determined by
* anesthesiologist.
* Patients undergoing elective surgeries under spinal anesthesia.
* Duration of surgery should not be more than 3 hours.
Exclusion Criteria:
* Patients having a documented history of severe adverse reactions to ketamine or ondansetron.
* Patients with cardiovascular disease documented in history.
* Patients with hepatic disease documented in history and supported by lab results (AST 32-40U/L), ALT(10-40U/L).
* Patients with renal disease documented in history and supported by lab results. Urea (10-50mg/dl) S/Creatinine (0.3-1.5mg/dl).
* Patients with hyperthyroidism documented in history and supported by lab results.
* Patients with history of mental illness, seizures and glaucoma.
* Patients with known hypertension (BP greater than 140/90).
* Haemodynamically unstable patients (BP\<100mmHg).
* Patients with coagulopathy or other bleeding diathesis documented in history and supported by lab results.
* Complicated prolonged surgeries in spinal anesthesia.
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
Frequency of Post Spinal Shivering
Timeframe: From 5 minutes after administration of study drug until transfer of the patient to the post-anesthesia care unit