Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury

Summary

This randomized controlled clinical trial aims to evaluate the effectiveness of dexmedetomidine compared with sufentanil on cerebral oxygen saturation in patients with traumatic brain injury (TBI) undergoing surgery under general anesthesia. Cerebral oxygen saturation (rSO₂) will be monitored using Near-Infrared Spectroscopy (NIRS) to assess the impact of both anesthetic regimens on cerebral oxygenation and hemodynamic stability.

Patients meeting the inclusion criteria will be randomly assigned into two groups (1:1 ratio) using a simple random draw method.

Group A will receive dexmedetomidine 1 µg/kg for induction, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by maintenance with dexmedetomidine 0.3 µg/kg/hour and sevoflurane 1-1.5 vol%.

Group B will receive sufentanil 0.2 µg/kg for induction, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by maintenance with sufentanil 0.2 µg/kg/hour and sevoflurane 1-1.5 vol%. Both groups will receive intravenous paracetamol 1 g for analgesia at the end of surgery.

All patients will remain intubated postoperatively and will be transferred to the Intensive Care Unit (ICU) for monitoring. NIRS probes will be placed bilaterally on the cleaned frontal regions to measure rSO₂ values preoperatively, intraoperatively, and postoperatively at 60 and 120 minutes after intervention.

Postoperative analgesia will consist of dexmedetomidine 0.3 µg/kg/hour with paracetamol 1 g every 8 hours in the dexmedetomidine group, and sufentanil 0.1 µg/kg/hour with paracetamol 1 g every 8 hours in the sufentanil group.

Clinical and hemodynamic parameters will be recorded throughout the perioperative period.

Data will be analyzed to compare cerebral oxygen saturation changes between the two groups, aiming to determine whether dexmedetomidine provides superior cerebral oxygenation compared with sufentanil in patients with traumatic brain injury undergoing neurosurgical procedures.

Conditions

• Traumatic Brain Injury
• Cerebral Oxygen Saturation
• NIR Spectroscopy

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine administered as a 1 µg/kg IV bolus over 10 minutes before induction, followed by continuous infusion at 0.3 µg/kg/h during surgery. Used for anesthesia maintenance in patients with traumatic brain injury.

DRUG

Sufentanil

Sufentanil administered as a 0.2 µg/kg IV bolus before induction, followed by continuous infusion at 0.2 µg/kg/h during surgery. Used for anesthesia maintenance in patients with traumatic brain injury.

Sponsors & Collaborators

• RS Prof. Dr. Margono Soekardjo Purwokerto

  collaborator UNKNOWN

• Universitas Jenderal Soedirman

  lead OTHER

Principal Investigators

• Rudi Prihatno, Sp.An-Ti-KNA · Universitas Jenderal Soedirman

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2025-07-31

Completion

2025-08-31

Countries

• Indonesia

Study Locations