Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity

Completed

• Conditions: Seizures; Craniotomy; Dexmedetomidine; Propofol; Remifentanil; Cerebral Tumor; Neurophysiology
• Interventions: Drug: Propofol

• Registration Number: NCT05103735
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-15
• Primary Completion: 2021-10-10
• Study Completion: 2021-10-11
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-02
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PROPOFOL-REMIFENTANYL	Propofol	Awake craniotomy under propofol-remifentanil sedation. Propofol and remifentanyl was administered through continuous intravenous infusion, starting 30 minutes prior to surgery. The end of the infusion was at the end of the surgical procedure. Propofol dosage: 0.2-2 mk/kg/h Remifentanyl dosage: 0.01-0.1 mcg/kg/min

Primary Outcome Measures

Name	Time	Method
SEIZURE ACTIVITY	DURING TUMOR RESECTION PHASE OF THE AWAKE CRANIOTOMY	INCIDENCE OF ELECTRO-CLINICAL SEIZURE ACTIVITY IN THE TWO GROUPS DURING RESECTIVE PHASE OF AWAKE CRANIOTOMY EVALUATED WITH ELECTROCORTICOGRAPHY.

Trial Locations

Locations (1)

Cristian Deana; 🇮🇹 Udine, Italy