NeurosurgeryDEX-NEURONCT07398066
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
A study testing Dexmedetomidine and Normal Saline (0.9% NaCl) in people with Neurosurgery and Brain Cancer, run by University of Malaya.
Trial summary
Post-craniotomy pain is common and often undertreated. Inadequate analgesia can lead to patient discomfort and higher opioid consumption, which may result in respiratory depression, sedation risks and impaired neurological assessment in the early postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neurosurgery, Brain Cancer, Meningioma
- What is being tested?
- Dexmedetomidine and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult (American Society of Anaesthesiologists (ASA 1-2) who >18 years old and <65 years old undergoing elective craniotomy
Who cannot join
- Patients who are ASA 3-5 or BMI <18/ >40 or allergic to dexmedetomidine will be excluded. Patients with high-grade heart block or uncontrolled bradyarrhythmia will also be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery: A Double-blinded Randomised Placebo-controlled Trial (DEX-NEURO Trial)
Post-craniotomy pain is common and often undertreated. Inadequate analgesia can lead to patient discomfort and higher opioid consumption, which may result in respiratory depression, sedation risks and impaired neurological assessment in the early postoperative period. The incidence of post-operative delirium after intracranial surgery was 19%, ranging from 12 to 26% caused by variation in clinical features and delirium assessment methods1. It is associated with increased morbidity, longer length of hospital stay, and harm to self or staffs.
Dexmedetomidine (Precedex) is a highly selective α2-adrenergic agonist with the properties of analgesia, sedative, anxiolytic and neuroprotection without significant respiratory depression. Most of the trials administered a loading dose of 0.5-1.0 μg/kg intravenous dexmedetomidine over 10 minutes followed by infusion dose 0.2-0.7 μg/kg/hour. The use of intraoperative dexmedetomidine is believed to reduce the usage of postoperative opioids where frequent neurological assessment is often required in neurosurgical patients. Beyond the benefit of analgesia, perioperative dexmedetomidine has been studied for prevention of postoperative delirium. Randomized trials in mixed noncardiac surgical populations reported that low-dose perioperative dexmedetomidine may reduce the incidence of delirium. Dexmedetomidine produces dose-dependent bradycardia and hypotension, which should be carefully monitored to maintain the cerebral perfusion pressure in brain surgery. However, most trials and meta-analyses have focused on general surgical or cardiac cohorts; the evidence remains limited in neurosurgical (craniotomy) patients.
Although it showed promising benefits of analgesia and neuroprotection in non-neurosurgical patients, recent meta-analyses of intraoperative dexmedetomidine reported high degree of heterogeneity due to the inclusion of varied procedures (elective vs emergent craniotomy), dosing regimes (loading dose only versus loading dose + infusion versus infusion only) and varied primary endpoints (postoperative pain scores, cumulative opioid consumption or incidence of delirium). Therefore, this randomized, double-blind, placebo-controlled trial is designed to examine the use of intravenous dexmedetomidine in the reduction of postoperative pain score and delirium in neurosurgical patients. We hypothesised that intravenous dexmedetomidine reduces postoperative pain score and delirium with lower need of rescue analgesia and amount of morphine consumption in patients undergoing craniotomy.
Read the detailed description
There are several similar studies been conducted in the literature search. However, the majority of the studies focus on the intensive care unit patient or non-neurosurgery patients. It is believed that intravenous dexmedetomidine can reduce the postoperative pain score with lesser need for rescue analgesia and morphine consumption to facilitate postoperative neurological assessment.
- Conditions
- Neurosurgery, Brain Cancer, Meningioma
- Being tested
- Dexmedetomidine, Normal Saline (0.9% NaCl)
- Keywords
- dexmedetomidine, precedex, neurosurgery, delirium, pain
- Medical subject headings
- Brain Neoplasms, Meningioma, Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour
Normal Saline (0.9% NaCl)Drug
Intravenous normal saline loading and infusion dose of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dexmedetomidine | Active comparator | Intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour Receives: Drug: Dexmedetomidine |
| Intravenous normal saline | Placebo comparator | intravenous normal saline loading and infusion dose Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score at recovery area
Numerical Rating Scale (0 no pain-10 most pain)
Measured: In the recovery area after pushing out from the operation theatre (Post-operative 1-hour, Day 1, Day 2)
Secondary outcomes (6)
Need of rescue analgesia
Need to receive additional analgesia (bolus of ketamine, fentanyl, morphine) in the recovery area
Measured: In the recovery area after pushing out from operation theatre (Post-operative 1-hour)
Total usage of postoperative morphine use in the first 24-hour
The amount of morphine usage in milligram
Measured: In the first 24-hour after surgery in neurointensive care unit
Postoperative nausea or vomiting
Incidence of nausea or vomiting in the first 24-hour in neurointensive care unit
Measured: Within the first 24-hour in neurointensive care unit
Incidence of delirium
Assessed by CAM-ICU scoring test
Measured: Day-1 and Day-2 in neurointensive care unit
Patient satisfaction scale of analgesia control
Numerical rating scale (0 not satisfy - 10 very satisfy)
Measured: Day-1 in neurointensive care unit
Adverse events of dexmedetomidine (hypotension and bradycardia).
systolic blood pressure < 90, heart rate <60
Measured: During surgery when intravenous dexmedetomidine is started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jan 2027 (estimated)
- Primary completion22 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Ting Ng, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398066
- Sponsor's protocol ID
- 16023
- Acronym
- DEX-NEURO
- Status last verified
- Nov 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
PubMed 27542303Zhao LH, Shi ZH, Chen GQ, Yin NN, Chen H, Yuan Y, Cao W, Xu M, Hao JJ, Zhou JX. Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients With Delayed Extubation After Craniotomy: A Randomized Controlled Trial. J Neurosurg Anesthesiol. 2017 Apr;29(2):132-139. doi: 10.1097/ANA.0000000000000260.
PubMed 26641648Bielka K, Kuchyn I, Babych V, Martycshenko K, Inozemtsev O. Dexmedetomidine infusion as an analgesic adjuvant during laparoscopic small es, Cyrillicholecystectomy: a randomized controlled study. BMC Anesthesiol. 2018 Apr 20;18(1):44. doi: 10.1186/s12871-018-0508-6.
PubMed 29678158Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial. PLoS One. 2017 Feb 9;12(2):e0170757. doi: 10.1371/journal.pone.0170757. eCollection 2017.
PubMed 28182690
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery: A Double-blinded Randomised Placebo-controlled Trial (DEX-NEURO Trial)
- ClinicalTrials.gov ID
- NCT07398066
- Acronym / sponsor ID
- DEX-NEURO / 16023
- Conditions
- Neurosurgery, Brain Cancer, Meningioma
- Keywords
- dexmedetomidine, precedex, neurosurgery, delirium, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 22 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2026 (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.
Post-craniotomy pain is common and often undertreated. Inadequate analgesia can lead to patient discomfort and higher opioid consumption, which may result in respiratory depression, sedation risks and impaired neurological assessment in the early postoperative period. The incidence of post-operative delirium after intracranial surgery was 19%, ranging from 12 to 26% caused by variation in clinical features and delirium assessment methods1. It is associated with increased morbidity, longer length of hospital stay, and harm to self or staffs.
Dexmedetomidine (Precedex) is a highly selective α2-adrenergic agonist with the properties of analgesia, sedative, anxiolytic and neuroprotection without significant respiratory depression. Most of the trials administered a loading dose of 0.5-1.0 μg/kg intravenous dexmedetomidine over 10 minutes followed by infusion dose 0.2-0.7 μg/kg/hour. The use of intraoperative dexmedetomidine is believed to reduce the usage of postoperative opioids where frequent neurological assessment is often required in neurosurgical patients. Beyond the benefit of analgesia, perioperative dexmedetomidine has been studied for prevention of postoperative delirium. Randomized trials in mixed noncardiac surgical populations reported that low-dose perioperative dexmedetomidine may reduce the incidence of delirium. Dexmedetomidine produces dose-dependent bradycardia and hypotension, which should be carefully monitored to maintain the cerebral perfusion pressure in brain surgery. However, most trials and meta-analyses have focused on general surgical or cardiac cohorts; the evidence remains limited in neurosurgical (craniotomy) patients.
Although it showed promising benefits of analgesia and neuroprotection in non-neurosurgical patients, recent meta-analyses of intraoperative dexmedetomidine reported high degree of heterogeneity due to the inclusion of varied procedures (elective vs emergent craniotomy), dosing regimes (loading dose only versus loading dose + infusion versus infusion only) and varied primary endpoints (postoperative pain scores, cumulative opioid consumption or incidence of delirium). Therefore, this randomized, double-blind, placebo-controlled trial is designed to examine the use of intravenous dexmedetomidine in the reduction of postoperative pain score and delirium in neurosurgical patients. We hypothesised that intravenous dexmedetomidine reduces postoperative pain score and delirium with lower need of rescue analgesia and amount of morphine consumption in patients undergoing craniotomy.
Detailed description
There are several similar studies been conducted in the literature search. However, the majority of the studies focus on the intensive care unit patient or non-neurosurgery patients. It is believed that intravenous dexmedetomidine can reduce the postoperative pain score with lesser need for rescue analgesia and morphine consumption to facilitate postoperative neurological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexmedetomidine | Active comparator | Drug: DexmedetomidineIntravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour |
| Intravenous normal saline | Placebo comparator | Drug: Normal Saline (0.9% NaCl)intravenous normal saline loading and infusion dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult (American Society of Anaesthesiologists (ASA 1-2) who >18 years old and <65 years old undergoing elective craniotomy
Key exclusion criteria (1 listed)
- Patients who are ASA 3-5 or BMI <18/ >40 or allergic to dexmedetomidine will be excluded. Patients with high-grade heart block or uncontrolled bradyarrhythmia will also be excluded.
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: Precedexintravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour | Drug | Intravenous dexmedetomidine |
| Normal Saline (0.9% NaCl)Intravenous normal saline loading and infusion dose of normal saline | Drug | Intravenous normal saline |
Primary outcome
Postoperative pain score at recovery area
Time frame: In the recovery area after pushing out from the operation theatre (Post-operative 1-hour, Day 1, Day 2)
Numerical Rating Scale (0 no pain-10 most pain)
6 secondary outcomes
Need of rescue analgesia
Time frame: In the recovery area after pushing out from operation theatre (Post-operative 1-hour)
Total usage of postoperative morphine use in the first 24-hour
Time frame: In the first 24-hour after surgery in neurointensive care unit
Postoperative nausea or vomiting
Time frame: Within the first 24-hour in neurointensive care unit
Incidence of delirium
Time frame: Day-1 and Day-2 in neurointensive care unit
Patient satisfaction scale of analgesia control
Time frame: Day-1 in neurointensive care unit
Adverse events of dexmedetomidine (hypotension and bradycardia).
Time frame: During surgery when intravenous dexmedetomidine is started
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 27542303Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
- Background: PubMed 26641648Zhao LH, Shi ZH, Chen GQ, Yin NN, Chen H, Yuan Y, Cao W, Xu M, Hao JJ, Zhou JX. Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients With Delayed Extubation After Craniotomy: A Randomized Controlled Trial. J Neurosurg Anesthesiol. 2017 Apr;29(2):132-139. doi: 10.1097/ANA.0000000000000260.
- Background: PubMed 29678158Bielka K, Kuchyn I, Babych V, Martycshenko K, Inozemtsev O. Dexmedetomidine infusion as an analgesic adjuvant during laparoscopic small es, Cyrillicholecystectomy: a randomized controlled study. BMC Anesthesiol. 2018 Apr 20;18(1):44. doi: 10.1186/s12871-018-0508-6.
- Background: PubMed 28182690Li X, Yang J, Nie XL, Zhang Y, Li XY, Li LH, Wang DX, Ma D. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial. PLoS One. 2017 Feb 9;12(2):e0170757. doi: 10.1371/journal.pone.0170757. eCollection 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal Saline (0.9% NaCl) in people with Neurosurgery and Brain Cancer, run by University of Malaya.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Ting Dr Ng, MBChB (+60379492411, katingng1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score at recovery area (time frame: In the recovery area after pushing out from the operation theatre (Post-operative 1-hour, Day 1, Day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07398066, which also lists 4 linked publications.
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 5 Nov 2026.