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

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine (Other)
• Overall Status: Completed
• CT.gov ID: NCT05103735
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Actual Duration (Days): 26
• Patients Per Site Per Month: 199

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy; Seizures; Dexmedetomidine; Propofol; Remifentanil; Cerebral Tumor; Neurophysiology	Drug: Propofol

Study Design

• Study Type: Observational
• Actual Enrollment: 170 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Propofol-remifentanil Versus Dexmedetomidine in Awake Craniotomy: an Intraoperative Neurophysiological Evaluation
• Actual Study Start Date: Sep 15, 2021
• Actual Primary Completion Date: Oct 10, 2021
• Actual Study Completion Date: Oct 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Propofol; awake neurosurgery under propofol-remifentanil sedation; Other Names: Remifentanil Dexmedetomidine
DEXMEDETOMIDINE Awake craniotomy under dexmedetomidine sedation. Dexmedetomidine 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. Dexmedetomidine dosage: 0.2-1 mcg/kg/h In this group, remifentanyl administration was allowed.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cristian Deana	Udine		Italy	33100

Sponsors and Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cristian Deana, Principal Investigator, Azienda Sanitaria-Universitaria Integrata di Udine
• ClinicalTrials.gov Identifier: NCT05103735
• Other Study ID Numbers: CRANIO-UDINE
• First Posted: Nov 2, 2021
• Last Update Posted: Nov 8, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Seizures; Dexmedetomidine; Remifentanil; Propofol

Study Results

No Results Posted as of Nov 8, 2021