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NOT YET RECRUITING
NCT07300826
PHASE4

Intravenous Dexmedetomidine Versus Midazolam in Preventing Shivering in Trauma Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Shivering is a common and significant complication following spinal anesthesia, with a reported incidence of 40-60% especially in trauma patients due to pain, stress response, blood loss, and disrupted thermoregulation. Shivering increases oxygen demand, impairs monitoring, and reduces patient comfort. Effective pharmacologic prevention of shivering is crucial in this population. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist. It is widely used as an adjunct to general as well as regional anesthesia for better hemodynamic stability, sedation, and prolonged duration of regional anesthesia and is effective in reducing shivering by centrally modulating thermoregulation. Midazolam, a GABA-A agonist, Intravenous midazolam premedication is commonly used for conscious sedation, anxiolysis, and amnesia with spinal anesthesia is also known to have anti-shivering properties attributed to its action on GABA-A receptors, promoting anxiolysis and possibly resetting the hypothalamic thermoregulatory threshold. There are limited clinical data comparing the effect of intravenous dexmedetomidine and midazolam and its effect on shivering

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01

Completion Date

2027-04

Last Updated

2025-12-24

Healthy Volunteers

No

Interventions

DRUG

Dexmedetomidine

Patients will receive i. v. dexmedetomidine 0.5 μg.kg-1 post-spinal anesthesia

DRUG

Midazolam

patients will receive i.v. midazolam 0.05 mg.kg-1 post-spinal anesthesia