Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07398066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-08-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score at recovery area', 'timeFrame': 'In the recovery area after pushing out from the operation theatre (Post-operative 1-hour, Day 1, Day 2)', 'description': 'Numerical Rating Scale (0 no pain-10 most pain)'}], 'secondaryOutcomes': [{'measure': 'Need of rescue analgesia', 'timeFrame': 'In the recovery area after pushing out from operation theatre (Post-operative 1-hour)', 'description': 'Need to receive additional analgesia (bolus of ketamine, fentanyl, morphine) in the recovery area'}, {'measure': 'Total usage of postoperative morphine use in the first 24-hour', 'timeFrame': 'In the first 24-hour after surgery in neurointensive care unit', 'description': 'The amount of morphine usage in milligram'}, {'measure': 'Postoperative nausea or vomiting', 'timeFrame': 'Within the first 24-hour in neurointensive care unit', 'description': 'Incidence of nausea or vomiting in the first 24-hour in neurointensive care unit'}, {'measure': 'Incidence of delirium', 'timeFrame': 'Day-1 and Day-2 in neurointensive care unit', 'description': 'Assessed by CAM-ICU scoring test'}, {'measure': 'Patient satisfaction scale of analgesia control', 'timeFrame': 'Day-1 in neurointensive care unit', 'description': 'Numerical rating scale (0 not satisfy - 10 very satisfy)'}, {'measure': 'Adverse events of dexmedetomidine (hypotension and bradycardia).', 'timeFrame': 'During surgery when intravenous dexmedetomidine is started', 'description': 'systolic blood pressure \\< 90, heart rate \\<60'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'precedex', 'neurosurgery', 'delirium', 'pain'], 'conditions': ['Neurosurgery', 'Brain Cancer', 'Meningioma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nDexmedetomidine (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.\n\nAlthough 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult (American Society of Anaesthesiologists (ASA 1-2) who \\>18 years old and \\<65 years old undergoing elective craniotomy\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT07398066', 'acronym': 'DEX-NEURO', 'briefTitle': 'DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery: A Double-blinded Randomised Placebo-controlled Trial (DEX-NEURO Trial)', 'orgStudyIdInfo': {'id': '16023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous dexmedetomidine', 'description': 'Intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intravenous normal saline', 'description': 'intravenous normal saline loading and infusion dose', 'interventionNames': ['Drug: Normal Saline (0.9% NaCl)']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'intravenous dexmedetomidine loading dose 0.5mcg/kg followed by 0.5mcg/kg/hour', 'armGroupLabels': ['Intravenous dexmedetomidine']}, {'name': 'Normal Saline (0.9% NaCl)', 'type': 'DRUG', 'description': 'Intravenous normal saline loading and infusion dose of normal saline', 'armGroupLabels': ['Intravenous normal saline']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ka Ting Dr Ng, MBChB', 'role': 'CONTACT', 'email': 'katingng1@gmail.com', 'phone': '+60379492411'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ka Ting Ng', 'investigatorAffiliation': 'University of Malaya'}}}}