Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-02 @ 3:49 AM
Study NCT ID:
NCT04691128
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2020-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desflurane and Brain Relaxation in Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015173', 'term': 'Supratentorial Neoplasms'}], 'ancestors': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077335', 'term': 'Desflurane'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2020-12-12', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of satisfactory brain relaxation', 'timeFrame': 'during surgery', 'description': 'Assessed by the neurosurgeon using a 4-point scale (1= perfectly relaxed, 2= satisfactorily relaxed, 3= firm brain, 4=bulging brain) at the opening of the dura mater, score 1 and 2 represent satisfactory brain relaxation'}], 'secondaryOutcomes': [{'measure': 'Emergence time', 'timeFrame': 'from drug discontinuation to eye opening, assessed up to 1 hours', 'description': 'from drug discontinuation to eye opening'}, {'measure': 'Extubation time', 'timeFrame': 'from drug discontinuation to tracheal extubation, assessed up to 1 hours', 'description': 'from drug discontinuation to tracheal extubation'}, {'measure': 'Postoperative complications', 'timeFrame': 'from drug discontinuation to discharge from PACU (Postanesthesia care unit), assessed up to 3 hours', 'description': 'incidence of hypoxemia, hypotension, hypertension, tachycardia, bradycardia, agitation, shivering.'}, {'measure': 'Postoperative pain and postoperative nausea and vomiting (PONV)', 'timeFrame': 'during the PACU stay and postoperative day 1.', 'description': 'evaluated by Visual Analogue Score(VAS).'}, {'measure': 'Duration in PACU (Postanesthesia care unit)', 'timeFrame': 'from entering PACU to exiting PACU, an expected average of 1 hour', 'description': 'time from entering PACU to exiting PACU'}, {'measure': 'Early postanesthesia cognitive recovery', 'timeFrame': 'at 15, 30min after tracheal extubation', 'description': 'evaluated by Short Orientation Memory Concentration Test (SOMCT)'}, {'measure': 'Dural tension', 'timeFrame': 'during surgery', 'description': 'evaluated using a 4-point scale after bone flap removal.'}, {'measure': 'Quality of anesthesia recovery', 'timeFrame': 'at postoperative day 1', 'description': 'assessed by quality of recovery-15 scale (QoR-15)'}, {'measure': 'Anesthesia expenses', 'timeFrame': 'at postoperative day 1', 'description': 'Total cost of anesthesia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Supratentorial Tumor']}, 'referencesModule': {'references': [{'pmid': '36624384', 'type': 'DERIVED', 'citation': 'Jiang Z, Wu Y, Liang F, Jian M, Liu H, Mei H, Han R. Brain relaxation using desflurane anesthesia and total intravenous anesthesia in patients undergoing craniotomy for supratentorial tumors: a randomized controlled study. BMC Anesthesiol. 2023 Jan 10;23(1):15. doi: 10.1186/s12871-023-01970-z.'}]}, 'descriptionModule': {'briefSummary': "Optional brain relaxation improves the surgeon's operating conditions and is likely to minimize the degree of retraction injury ,with the potential for providing patients with a better outcome. The choice of anesthetic drugs can affect intraoperative brain relaxation. Propofol suppresses brain metabolism, reduces cerebral blood flow, and provides satisfactory brain relaxation. Desflurane is often criticized in neurosurgery due to its cerebral vasodilation and potential to increase intracranial pressure, however, it has been found to have a little clinical significance. This study intends to compare the effects of desflurane with propofol on brain relaxation in patients with supratentorial tumors under mild hyperventilation, and to provide new clinical evidence for the use of desflurane in neurosurgical anesthesia.", 'detailedDescription': 'To compare the effect of desflurane versus propofol combined with remifentanil anesthesia on brain relaxation in patients undergoing supratentorial tumor surgery with mild hyperventilation, and compare the emergence time and common complications during recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-60 years\n* Scheduled for elective craniotomy for supratentorial cerebral tumors\n* ASA status I-III\n* Glasgow score of 15\n* No clinical signs of intracranial hypertension\n* Preoperative brain imaging (CT or MRI) with midline shift less than 5mm\n* Informed consent signed by patients\n\nExclusion Criteria:\n\n* Scheduled intraoperative motor evoked potential monitoring\n* Patients with cerebral vascular diseases\n* Uncontrolled cardiopulmonary disease\n* Schedule to retain tracheal intubation after surgery\n* Unable to comprehend and cooperate with the examination\n* BMI \\> 30 Kg/m-2\n* Emergency surgery\n* History of related anesthetic allergy'}, 'identificationModule': {'nctId': 'NCT04691128', 'briefTitle': 'Desflurane and Brain Relaxation in Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Comparison of Desflurane and Propofol for Brain Relaxation in Patients Undergoing Supratentorial Craniotomy：a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'H199510180629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desflurane inhalational anesthesia', 'interventionNames': ['Drug: Desflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol total intravenous anesthesia', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Desflurane', 'type': 'DRUG', 'otherNames': ['inhalational anesthesia'], 'description': 'After induction, anesthesia will be maintained with 0.8-1.3 MAC desflurane and 0.05-0.2 μg/kg/min remifentanil.', 'armGroupLabels': ['Desflurane inhalational anesthesia']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['TIVA', 'total intravenous anesthesia'], 'description': 'After induction, anesthesia will be maintained with 6-8 mg/kg/h propofol and 0.05- 0.2 μg/kg/min remifentanil', 'armGroupLabels': ['Propofol total intravenous anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruquan Han', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}