An interventional study of Dexmedetomidine and Normal Saline (0.9% NaCl) in Neurosurgery, Brain Cancer and Meningioma, sponsored by University of Malaya. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 60 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
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Intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour
Drug: Dexmedetomidine
intravenous normal saline loading and infusion dose
Drug: Normal Saline (0.9% NaCl)
intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour
Also known as: Precedex
Intravenous normal saline loading and infusion dose of normal saline
Postoperative pain score at recovery area
Numerical Rating Scale (0 no pain-10 most pain)
Time frame: In the recovery area after pushing out from the operation theatre (Post-operative 1-hour, Day 1, Day 2)
Need of rescue analgesia
Need to receive additional analgesia (bolus of ketamine, fentanyl, morphine) in the recovery area
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
The amount of morphine usage in milligram
Time frame: 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
Time frame: Within the first 24-hour in neurointensive care unit
Incidence of delirium
Assessed by CAM-ICU scoring test
Time frame: Day-1 and Day-2 in neurointensive care unit
Patient satisfaction scale of analgesia control
Numerical rating scale (0 not satisfy - 10 very satisfy)
Time frame: Day-1 in neurointensive care unit
Adverse events of dexmedetomidine (hypotension and bradycardia).
systolic blood pressure \< 90, heart rate \<60
Time frame: During surgery when intravenous dexmedetomidine is started
No study locations are listed for this record.
Plan to share: Undecided
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University of Malaya