drugset / Trial / NCT07327879

Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering

NCT07327879

Phase 3 Not yet recruiting 120 enrolled Al-Azhar University Benha University · collab
RandomizedParallel-groupDouble-blindPrevention

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

EvaluationDrugModalityDoseRoute
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