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

NCT07300826 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-12-24

No results posted yet for this study

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

Conditions

  • Lower Limb Orthopedic Surgery

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-02-28
Completion
2027-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300826 on ClinicalTrials.gov