Trial intelligence / Profile preview

Intrathecal Dexmedetomidine for Post-Spinal Shivering

NCT07327879Phase 3

Key facts

Status: Not yet recruiting
Start: Jan 2026
Primary completion: Nov 2026
Countries: 1
Sponsor: Al-Azhar University
Modality: Small Molecules

Drugs: dexmedetomidine
Conditions: post-spinal shivering (PSS)

Overview

Phase 3, randomised, double-blind trial of dexmedetomidine in post-spinal shivering (PSS) (4 arms), sponsored by Al-Azhar University. Primary endpoint: Incidence of clinically significant shivering. Planned start Jan 2026; status: not yet recruiting.

Design

4 arms

Study design: RandomizedDouble-blind

Placebo Control
Bupivacaine + normal saline
Low-Dose Dexmedetomidine
Bupivacaine + dexmedetomidine 2.5 µg
Moderate-Dose Dexmedetomidine
Bupivacaine + dexmedetomidine 5 µg
Higher-Dose Dexmedetomidine
Bupivacaine + dexmedetomidine 10 µg

Who it enrols

Adults aged 18-75 scheduled for ureteric stone removal surgery with ASA physical status I-III, excluding those with preexisting bradycardia, AV block, severe hepatic dysfunction, uncontrolled hypotension, or chronic use of alpha-2 agonists/antagonists.

Endpoints

Primary

Incidence of clinically significant shivering60 minutes post-spinal

Secondary

Time to first shivering episode60 minutes post-spinal
Requirement of rescue anti-shivering drugintraoperative
Dose of rescue anti-shivering drugintraoperative
Sedation level24 hours postoperatively
Patient satisfactionprior to discharge from PACU
Time to first analgesic request24 hours postoperatively

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