Traumatic Brain InjuryDESTINNCT07244822
Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury
A study testing Dexmedetomidine and Sufentanil in people with Traumatic Brain Injury and Cerebral Oxygen Saturation, run by Universitas Jenderal Soedirman at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Oxygen Saturation, NIR Spectroscopy
- What is being tested?
- Dexmedetomidine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury (DESTIN Trial)
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.
Read more
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.
Read the 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.
- Being tested
- Dexmedetomidine, Sufentanil
- Keywords
- Traumatic Brain Injury, RSO2, NIRS, Dexmedetomidine, Sufentanil
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Neodex, Dexmeto
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.
SufentanilDrug
Also called Sufenta
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before induction), 60 minutes after surgery, and 120 minutes after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jun 2025
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Jenderal Soedirman
- Sponsor type
- University, hospital or other
- Collaborators
- RS Prof. Dr. Margono Soekardjo Purwokerto
- Responsible party
- Principal investigator, MM Rudi Prihatno, Universitas Jenderal Soedirman
- Investigators
- Rudi Prihatno, Sp.An-Ti-KNA, Principal investigator, Universitas Jenderal Soedirman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244822
- Sponsor's protocol ID
- Jenderal Soedirman University
- Other IDs
- 079/KEPK/PE/VI/2025
- Acronym
- DESTIN
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared because of institutional privacy policy and ethical considerations involving patient data from RSUD Prof. Dr. Margono Soekarjo Purwokerto.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effectiveness of Dexmedetomidine Versus Sufentanil on Cerebral Oxygen Saturation in Patients With Traumatic Brain Injury (DESTIN Trial)
- ClinicalTrials.gov ID
- NCT07244822
- Acronym / sponsor ID
- DESTIN / Jenderal Soedirman University
- Keywords
- Traumatic Brain Injury, RSO2, NIRS, Dexmedetomidine, Sufentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitas Jenderal SoedirmanUniversity, hospital or other
- Collaborators
- RS Prof. Dr. Margono Soekardjo Purwokerto
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Active comparator | Drug: DexmedetomidinePatients 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. |
| Sufentanil group | Active comparator | Drug: SufentanilPatients 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Neodex, DexmetoDexmedetomidine 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 | Dexmedetomidine group |
| SufentanilAlso: SufentaSufentanil 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. | Drug | Sufentanil group |
Primary outcome
Cerebral oxygen saturation (rSO₂) measured by Near-Infrared Spectroscopy (NIRS)
Time frame: Baseline (before induction), 60 minutes after surgery, and 120 minutes after surgery.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared because of institutional privacy policy and ethical considerations involving patient data from RSUD Prof. Dr. Margono Soekarjo Purwokerto.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudi Prihatno, Sp.An-Ti-KNA principal investigator
Universitas Jenderal Soedirman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Sufentanil in people with Traumatic Brain Injury and Cerebral Oxygen Saturation, run by Universitas Jenderal Soedirman at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral oxygen saturation (rSO₂) measured by Near-Infrared Spectroscopy (NIRS) (time frame: Baseline (before induction), 60 minutes after surgery, and 120 minutes after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.