Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering (NCT07327879) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering
Egypt120 participantsStarted 2026-01-28
Plain-language summary
Dexmedetomidine, a highly selective α2-adrenergic agonist, when used intrathecally as an adjuvant to local anesthetics, prolongs sensory/motor block and may blunt thermoregulatory shivering mechanisms. Several randomized controlled trials and meta-analyses have demonstrated decreased shivering incidence with intrathecal dexmedetomidine, but reported doses vary (commonly 2.5, 5, and 10 µg, and in some trials up to 15-20 µg), and the balance between efficacy and adverse effects (sedation, bradycardia, and hypotension) is not fully established. Hence, a head-to-head randomized comparison of several low-to-moderate intrathecal doses is warranted.
Objective: to compare the safety and efficacy of three intrathecal dexmedetomidine doses (2.5 µg, 5 µg, 10 µg) versus placebo for the prevention of post-spinal shivering.
Who can participate
Age range
18 Years – 75 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:
* Adult patients (age 18-75 years)
* Scheduled for ureteric stone removal surgery
* ASA(American Society of Anesthesiologists) physical status I, II, or III
* Able to provide informed consent
Exclusion Criteria:
* Known allergy to dexmedetomidine, bupivacaine, or other study medications
* Preexisting bradycardia (heart rate \<50 beats per minute)
* Second- or third-degree atrioventricular (AV) block without a pacemaker
* Severe hepatic dysfunction
* Uncontrolled hypotension
* Pregnancy
* Chronic use of α₂-agonists or antagonists (e.g., clonidine, tizanidine)
* Infection at the planned spinal puncture site
* Coagulopathy or bleeding disorder
* Inability to rate or communicate shivering (e.g., language barrier, cognitive impairment)
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 of clinically significant shivering
Timeframe: Throughout the intraoperative period until 60 minutes post-spinal.