Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering
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.
Timeline
- Start
- 2026-01-28
- Primary completion
- 2026-11-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 2.5 ug | Intrathecal |
| Subject | Dexmedetomidine | Other / unclassified | 5 ug | Intrathecal |
| Subject | Dexmedetomidine | Other / unclassified | 10 ug | Intrathecal |
| Background | Bupivacaine | Other / unclassified | 15 mg | Intrathecal |