Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time from discontinuing anesthesia and extubation.
during 24 hours
Souhayl DAHMANI, MD,PhD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health