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

NCT ID: NCT07300826

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Lower Limb Orthopedic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group D

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Group M

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Mohamed Gad

residant doctor at Assiut university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Dexmedetomidine VS Midazolam

Identifier Type: -

Identifier Source: org_study_id