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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07300826

Enrollment

100

Registered

2025-12-24

Start date

2026-01-31

Completion date

2027-04-30

Last updated

2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Orthopedic Surgery

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

Interventions

DRUGDexmedetomidine

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

DRUGMidazolam

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of shivering	1 hours postoperative	Incidence of shivering intraoperatively every 10 min and postoperatively every 15 min for 1 hour

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026