NCT07244822

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

A Randomized Controlled Trial Comparing the Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury (DESTIN Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Universitas Jenderal Soedirman · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Traumatic brain injury (TBI) is a major cause of morbidity and mortality worldwide, often leading to secondary brain injury caused by hypoxia, ischemia, and impaired cerebral autoregulation. During anesthesia and surgery, maintaining adequate cerebral oxygenation is critical to prevent secondary neuronal damage. Cerebral oxygen saturation, measured by Near-Infrared Spectroscopy (NIRS), provides a continuous and noninvasive assessment of regional cerebral oxygenation (rSO₂), reflecting the balance between oxygen delivery and consumption in brain tissue. Opioids such as sufentanil have traditionally been used to provide analgesia and hemodynamic stability during anesthesia in neurosurgical patients. However, opioid-related adverse effects, including respiratory depression, hypercapnia, and potential increases in intracranial pressure, raise concerns in patients with brain injury. Dexmedetomidine, a selective α₂-adrenergic receptor agonist, has sedative, analgesic, and sympatholytic properties without significant respiratory depression. It is known to reduce cerebral metabolic rate and intracranial pressure while maintaining cerebral perfusion, making it a potentially advantageous agent in neuroanesthesia. This randomized controlled clinical trial aims to compare the effectiveness of dexmedetomidine versus sufentanil on cerebral oxygen saturation in patients with traumatic brain injury undergoing surgery. The hypothesis is that dexmedetomidine provides better maintenance of cerebral oxygenation, as measured by NIRS, compared to sufentanil under equivalent anesthetic conditions. Eligible participants will be randomly allocated into two groups (1:1 ratio). The dexmedetomidine group will receive an induction dose of dexmedetomidine 1 µg/kg, 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%. The sufentanil group will receive sufentanil 0.2 µg/kg, thiopental 5 mg/kg, and rocuronium 0.6 mg/kg, followed by sufentanil 0.2 µg/kg/hour and sevoflurane 1-1.5 vol%. All patients will receive intravenous paracetamol 1 g at the end of surgery for postoperative analgesia. Postoperatively, patients will remain intubated and monitored in the Intensive Care Unit (ICU). Cerebral oxygen saturation (rSO₂) will be recorded using NIRS probes placed bilaterally on the frontal region before induction, during surgery, and at 60 and 120 minutes post-intervention in the ICU. Additional hemodynamic parameters including heart rate, mean arterial pressure, and oxygen saturation will also be recorded. The primary outcome of this study is the change in cerebral oxygen saturation (rSO₂) between the two groups. Data obtained will be analyzed statistically to determine the comparative effectiveness of dexmedetomidine and sufentanil in maintaining optimal cerebral oxygenation during neurosurgical anesthesia in patients with traumatic brain injury. Findings from this study are expected to provide evidence-based recommendations for optimizing anesthetic management in neurotrauma cases, minimizing secondary brain injury, and improving patient outcomes.

Conditions

• Traumatic Brain Injury
• Cerebral Oxygen Saturation
• NIR Spectroscopy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-07-31
• Completion: 2025-08-31
• First posted: 2025-11-24
• Last updated: 2025-11-28

Locations

1 site across 1 country: Indonesia