Anaesthesia for Supratentorial Tumor Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil

Conditions
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Supratentorial Neoplasms

Intervention / Treatment
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* Drug: Comparison of two anesthetics protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for supratentorial brain tumors remove. Age : 18 to 75. ASA 1 or 2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>propofol et remifentanil | Drug: Comparison of two anesthetics protocol<br>* Comparison of two anesthetics protocol<br>|
| Experimental: 2<br>sevoflurane et sufentanil | Drug: Comparison of two anesthetics protocol<br>* Comparison of two anesthetics protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from discontinuing anesthesia and extubation. |  | during 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supratentorial brain tumors, propofol, sevoflurane, remifentanil, sufentanil.