Overview

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

Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
Dexmedetomidine, a highly selective 2-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 g, and in some trials up to 15-20 g), 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 g, 5 g, 10 g) versus placebo for the prevention of post-spinal shivering.
Phase:
PHASE3
Details
Lead Sponsor:
Al-Azhar University
Collaborator:
Benha University