Clinical trial

Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation

Name
CRANIO-UDINE
Description
Awake craniotomy require a cooperative patient during resection neurosurgery phase. Anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters. Neurosurgeon could be help by Intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. Propofol and remifentanyl have been largely used. Dexmedetomidine represents an alternative. However little is known about the role of dexmedetomidine on Intraoperative electrocorticography.
Trial arms
Trial start
2021-09-15
Estimated PCD
2021-10-10
Trial end
2021-10-11
Status
Completed
Treatment
Propofol
awake neurosurgery under propofol-remifentanil sedation
Arms:
PROPOFOL-REMIFENTANYL
Other names:
Remifentanil, Dexmedetomidine
Size
170
Primary endpoint
SEIZURE ACTIVITY
DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY
Eligibility criteria
Inclusion Criteria: * PATIENTS UNDERGOING AWAKE CRANIOTOMY FOR TUMOR RESECTION (EXCLUDED E.G. SURGERY OF EPILEPSIA) * INTRAOPERATIVE MONITORING (IOM) WITH ELECTROCORTICOGRAPHY * AWAKE-AWAKE-AWAKE TECHNIQUE Exclusion Criteria: * AGE \<18 YEARS OLD * NON AWAKE-AWAKE-AWAKE TECHNIQUE * ABSENCE OF IOM
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 170, 'type': 'ACTUAL'}}
Updated at
2023-01-31

1 organization

1 product

7 indications

Product
Propofol
Indication
Craniotomy
Indication
Seizure
Indication
Dexmedetomidine
Indication
Propofol
Indication
Remifentanil
Indication
Brain Tumor
Indication
Neurophysiology