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

NCT07244822 | Completed DMC

• 2 other identifiers: Jenderal Soedirman University079/KEPK/PE/VI/2025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Traumatic Brain Injury; RSO2; NIRS; Dexmedetomidine; Sufentanil

Outcome Measures

Primary Outcomes (1)

• Cerebral oxygen saturation (rSO₂) measured by Near-Infrared Spectroscopy (NIRS)

  Measurement of regional cerebral oxygen saturation (rSO₂) using Near-Infrared Spectroscopy (NIRS) placed bilaterally on the forehead. The mean rSO₂ values during and after anesthesia will be compared between the dexmedetomidine and sufentanil groups to assess cerebral oxygenation before and after surgery in traumatic brain injury patients.

  Baseline (before induction), 60 minutes after surgery, and 120 minutes after surgery.

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

Patients receive dexmedetomidine 1 µg/kg IV bolus for induction, followed by maintenance infusion at 0.3 µg/kg/h, combined with thiopental 5 mg/kg, rocuronium 0.6 mg/kg, and sevoflurane 1-1.5 vol% for maintenance anesthesia.

Drug: Dexmedetomidine

Sufentanil group

ACTIVE COMPARATOR

Patients receive sufentanil 0.2 µg/kg IV bolus for induction, followed by maintenance infusion at 0.2 µg/kg/h, combined with thiopental 5 mg/kg, rocuronium 0.6 mg/kg, and sevoflurane 1-1.5 vol% for maintenance anesthesia.

Drug: Sufentanil

Interventions

Dexmedetomidine DRUG

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.

Also known as: Neodex, Dexmeto

Dexmedetomidine group

Sufentanil DRUG

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.

Also known as: Sufenta

Sufentanil group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-65 years diagnosed with traumatic brain injury (TBI) requiring surgical intervention under general anesthesia.
• Classified as ASA Physical Status I-III.
• Undergoing elective or emergency craniotomy at RSUD Prof. Dr. Margono Soekarjo Purwokerto.
• Provide informed consent (patient or legal representative).

You may not qualify if:

• Patients with severe cardiovascular instability (e.g., shock, uncontrolled arrhythmia).
• History of allergy or hypersensitivity to dexmedetomidine or sufentanil.
• Severe hepatic or renal impairment.
• Pregnant or lactating women.
• Glasgow Coma Scale ≤ 8 before induction.
• Refusal of participation or incomplete consent.

Sponsors & Collaborators

• Universitas Jenderal Soedirman: lead
• RS Prof. Dr. Margono Soekardjo Purwokerto: collaborator

Study Sites (1)

RSUD Prof. Margono Soekarjo

Purwokerto, Central Java, 53122, Indonesia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Dexmedetomidine; Sufentanil

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Rudi Prihatno, Sp.An-Ti-KNA

  Universitas Jenderal Soedirman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study uses a double-blind design. Both the participants and the principal investigator are blinded to group allocation. Randomization is performed using a simple draw method assigning subjects to Group A or Group B. The anesthetic drugs (dexmedetomidine or sufentanil) are prepared and administered by an anesthesia team member who is not involved in data collection or outcome assessment. The study drugs are provided in identical, unlabeled syringes to ensure blinding. Neither the patients nor the investigator responsible for data recording and analysis will know which drug is administered until the study is completed and unblinding is authorized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neuroanesthesiologist and Dean, Faculty of Medicine, Universitas Jenderal Soedirman

Model Details: This is a randomized, controlled, parallel-group clinical trial designed to compare the effectiveness of dexmedetomidine versus sufentanil on cerebral oxygen saturation in patients with traumatic brain injury (TBI) undergoing surgery under general anesthesia. Participants will be randomly assigned in a 1:1 ratio into two intervention groups. The dexmedetomidine group will receive an induction dose of 1 µg/kg followed by maintenance at 0.3 µg/kg/hour, while the sufentanil group will receive an induction dose of 0.2 µg/kg followed by maintenance at 0.2 µg/kg/hour. Cerebral oxygen saturation will be continuously monitored using NIRS at baseline and postoperatively. The study aims to determine whether dexmedetomidine provides superior preservation of cerebral oxygenation compared to sufentanil. Randomization will be performed performed using simple random allocation (drawing method). Data will be analyzed based on intention-to-treat principles to compare changes in rSO₂ between two groups.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: June 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)