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

NCT07300826 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Dexmedetomidine VS Midazolam
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of shivering

  Incidence of shivering intraoperatively every 10 min and postoperatively every 15 min for 1 hour

  1 hours postoperative

Study Arms (2)

Group D

EXPERIMENTAL

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

Drug: Dexmedetomidine

Group M

EXPERIMENTAL

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

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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

Group D

Midazolam DRUG

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

Group M

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• : ASA I-II Adult trauma patients (age 18-60 years). Undergoing lower limb orthopedic surgery with tourniquet under spinal anesthesia

You may not qualify if:

• \- Allergy to study drugs. Severe cardiovascular, hepatic, or renal disease Hypovolemic shock. History of psychiatric illness or chronic sedative use. Bradycardia (\<50 bpm), heart block, or uncontrolled hypotension. Febrile illness or use of active warming devices

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12