Awake vs. Asleep Craniotomy for Non-eloquent Gliomas

Not Applicable

Completed

• Conditions: Intracranial Glioma
• Interventions: Procedure: Non-awake Anesthesia Protocol; Procedure: Awake Anesthesia Protocol

• Registration Number: NCT03621748
• Lead Sponsor: Mayo Clinic

Brief Summary

This study protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).

Detailed Description

This is a single-center, prospective randomized open or non-blinded end-point (PROBE) clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups utilizing a dynamic minimization approach. The experimental group with randomization of patients who will undergo awake craniotomy for both high and low grade gliomas in non-eloquent areas or a control group of patients who will have asleep craniotomy for both high and low grade gliomas in non-eloquent regions.

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-08
• Study Start: 2019-06-01
• Status Verified: 2023-05
• Primary Completion: 2023-05-21
• Study Completion: 2023-05-21
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Awake Cohort	Non-awake Anesthesia Protocol	Cohort undergoing craniotomy utilizing general anesthesia protocol
Awake Cohort	Awake Anesthesia Protocol	Cohort undergoing craniotomy utilizing awake anesthesia protocol

Primary Outcome Measures

Name	Time	Method
Extent of resection	up to 48 hrs post operation	Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI

Secondary Outcome Measures

Name	Time	Method
Length of Surgery	Intraoperative	defined as time entering OR and leaving OR
VAS Postoperative anxiety	Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth	Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)
Percentage of baseline tumor volume resected	up to 48 hrs post operation	Measured by MRI

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States