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

NCT07398066 | Not Yet Recruiting DMC

• 1 other identifier: 16023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurosurgery; Brain Cancer; Meningioma

Keywords

dexmedetomidine; precedex; neurosurgery; delirium; pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score at recovery area

  Numerical Rating Scale (0 no pain-10 most pain)

  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

  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

  In the first 24-hour after surgery in neurointensive care unit

• Postoperative nausea or vomiting

  Within the first 24-hour in neurointensive care unit

• Incidence of delirium

  Day-1 and Day-2 in neurointensive care unit

• Patient satisfaction scale of analgesia control

  Day-1 in neurointensive care unit

Study Arms (2)

Intravenous dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Intravenous normal saline

PLACEBO COMPARATOR

intravenous normal saline loading and infusion dose

Drug: Normal Saline (0.9% NaCl)

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Intravenous dexmedetomidine

Normal Saline (0.9% NaCl) DRUG

Intravenous normal saline loading and infusion dose of normal saline

Intravenous normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (4)

• Su X, Meng ZT, Wu XH et al. Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery : a randomised , double-blind , placebo-controlled trial. The Lancet 2016;388:1893-902

  BACKGROUND

• Zhao LH, Shi ZH, Chen GQ, et al. Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients With Delayed Extubation After Craniotomy: A Randomized Controlled Trial. J Neurosurg Anesthesiol 2017;29:132-9

  BACKGROUND

• Bielka K, Kuchyn L, Babych V, Martycshenko K, Innozemtsev O. Dexmedetomidine infusion as an analgesic adjuvant during laparoscopic сholecystectomy : a randomized controlled study. BMC Anesthesiology 2018;18:1-6

  BACKGROUND

• Li X, Yang J, Nie XL et al. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery : A randomized controlled trial. PLoS ONE 2017;12:1-15.

  BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Meningioma; Delirium; Pain

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ka Ting Dr Ng, MBChB

CONTACT

+60379492411; katingng1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 9, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): August 22, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-01