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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)

DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery: A Double-blinded Randomised Placebo-controlled Trial (DEX-NEURO Trial)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07398066
Acronym
DEX-NEURO
Enrollment
60
Registered
2026-02-09
Start date
2026-07-22
Completion date
2027-08-22
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Cancer, Meningioma, Neurosurgery

Keywords

dexmedetomidine, precedex, neurosurgery, delirium, pain

Brief 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. 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.

Interventions

DRUGDexmedetomidine

intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour

DRUGNormal Saline (0.9% NaCl)

Intravenous normal saline loading and infusion dose of normal saline

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* All adult (American Society of Anaesthesiologists (ASA 1-2) who \>18 years old and \<65 years old undergoing elective craniotomy

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain score at recovery areaIn 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)

Secondary

MeasureTime frameDescription
Patient satisfaction scale of analgesia controlDay-1 in neurointensive care unitNumerical rating scale (0 not satisfy - 10 very satisfy)
Incidence of deliriumDay-1 and Day-2 in neurointensive care unitAssessed by CAM-ICU scoring test
Total usage of postoperative morphine use in the first 24-hourIn the first 24-hour after surgery in neurointensive care unitThe amount of morphine usage in milligram
Postoperative nausea or vomitingWithin the first 24-hour in neurointensive care unitIncidence of nausea or vomiting in the first 24-hour in neurointensive care unit
Adverse events of dexmedetomidine (hypotension and bradycardia).During surgery when intravenous dexmedetomidine is startedsystolic blood pressure \< 90, heart rate \<60
Need of rescue analgesiaIn the recovery area after pushing out from operation theatre (Post-operative 1-hour)Need to receive additional analgesia (bolus of ketamine, fentanyl, morphine) in the recovery area

Contacts

CONTACTKa Ting Dr Ng, MBChB
katingng1@gmail.com+60379492411

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026