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Clinical Trials/NCT05103735
NCT05103735
Completed
Not Applicable

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

Azienda Sanitaria-Universitaria Integrata di Udine1 site in 1 country170 target enrollmentStarted: September 15, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
170
Locations
1
Primary Endpoint
SEIZURE ACTIVITY

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

PROPOFOL-REMIFENTANYL

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

Intervention: Propofol (Drug)

Outcomes

Primary Outcomes

SEIZURE ACTIVITY

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cristian Deana

Principal Investigator

Azienda Sanitaria-Universitaria Integrata di Udine

Study Sites (1)

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