Anaesthesia for Supratentorial Tumor Resection

Phase 3

Completed

• Conditions: Supratentorial Neoplasms
• Interventions: Drug: Comparison of two anesthetics protocol

• Registration Number: NCT00389883
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This is a double center, multidisciplinary, prospective, randomized, double-blind, with a superiority hypothesis, trial including 100 patients scheduled for resection of a supratentorial brain tumour under general anesthesia.

Detailed Description

On the morning of surgery, patients will be randomly allocated to one of the two following groups : target concentration-delivered propofol-remifentanil versus sufentanil-sevoflurane. The primary judgement criterion will be the rapidity of awakening, defined as the time between the cessation of administration of the last anesthetic until extubation. Several secondary judgement criteria related to quality of postoperative recovery and complications will be collected. The hypothesis tested is a 30% reduction of the time necessary to extubate patients after cessation of anesthetic delivery in the propofol-remifentanil group. Based on previous works, using an risk of 20 % and an of 5 %, 100 patients must be included in this study (50 or each group). Statistical analysis will be performed by WILCOXON MANN, WHITNEY and X2 tests based on the type of variables.

The results of this study should provide a first choice anaesthetic regimen to optimize postoperative recovery of neurosurgical patients undergoing resection of supratentorial brain tumours. They will contribute to the improvement in the management of patients suffering from cancer.

Study Timeline

• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Study Start: 2006-11
• Primary Completion: 2010-01
• Study Completion: 2011-11
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Patient scheduled for supratentorial brain tumors remove.
• Age : 18 to 75.
• ASA 1 or 2.

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Exclusion Criteria

• Disagree of patient to participate
• Intubation required in the postoperative care unit
• Contraindication of one of the anesthetics used in the study
• Pregnancy
• Craniotomy in the frontal area (no depth of anesthesia monitoring)
• Patient's inability to quantified its pain.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Comparison of two anesthetics protocol	propofol et remifentanil
2	Comparison of two anesthetics protocol	sevoflurane et sufentanil

Primary Outcome Measures

Name	Time	Method
Time from discontinuing anesthesia and extubation.	during 24 hours

Secondary Outcome Measures

Name	Time	Method
Speed of emergence from anesthesia : time from discontinuing anesthesia to spontaneous breathing, opening the eyes, response to simple order and discharge from postoperative care unit.	during 24 hours
Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.	during 24 hours
Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.	during 24 hours

Trial Locations

Locations (2)

Centre Hospitalier Universitaire.; 🇫🇷 Besancon, France

Hopital BEAUJON ASSISTANCE PUBLIQUE; 🇫🇷 Clichy, France