Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthes… (NCT07043049) | Clinical Trial Compass
CompletedPhase 3
Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering
Pakistan92 participantsStarted 2022-06-29
Plain-language summary
The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries.
The main questions it aims to answer are:
* Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia?
* Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine?
Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.
Participants will:
* Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia.
* Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale.
* Be monitored for sedation, nausea, and other possible side effects.
Who can participate
Age range
20 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
. Patients aged 20 to 65 years,
. American Society of Anesthesiologists (ASA) Physical Status I or II, and
. Scheduled for elective lower abdominal or inguinoscrotal surgeries
. Under spinal anesthesia were included
Exclusion criteria
. Thyroid or neuromuscular disorders,
. Pregnant
. History of chronic sedative or narcotic use,
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
Incidence and Severity of Post-Spinal Anesthesia Shivering
Timeframe: Up to 60 minutes post spinal anesthesia