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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Cancer; Meningioma; Neurosurgery
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal Saline (0.9% NaCl)

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Ting Dr Ng, MBChB; Phone Number: +60379492411; Email: katingng1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous dexmedetomidine; Intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour	Drug: Dexmedetomidine; intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour; Other Names: Precedex
Placebo Comparator: Intravenous normal saline; intravenous normal saline loading and infusion dose	Drug: Normal Saline (0.9% NaCl); Intravenous normal saline loading and infusion dose of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of rescue analgesia	Need to receive additional analgesia (bolus of ketamine, fentanyl, morphine) in the recovery area	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	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	Within the first 24-hour in neurointensive care unit
Incidence of delirium	Assessed by CAM-ICU scoring test	Day-1 and Day-2 in neurointensive care unit
Patient satisfaction scale of analgesia control	Numerical rating scale (0 not satisfy - 10 very satisfy)	Day-1 in neurointensive care unit
Adverse events of dexmedetomidine (hypotension and bradycardia).	systolic blood pressure < 90, heart rate <60	During surgery when intravenous dexmedetomidine is started

Collaborators and Investigators

• Sponsor: University of Malaya

Publications and helpful links

General Publications

• 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
• 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
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 22, 2026
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): August 22, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pain; delirium; dexmedetomidine; neurosurgery; precedex
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Delirium; Meningioma; Brain Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Imidazoles; Crystalloid Solutions; Isotonic Solutions; Solutions; Dexmedetomidine; Saline Solution
• Other Study ID Numbers: 16023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No