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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00389883 |
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.
Condition | Intervention | Phase |
---|---|---|
Supratentorial Brain Tumors |
Drug: Comparison of two anesthetics protocol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Anaesthesia for Supratentorial Tumor Resection : a Double-Blind Comparison of Target Plasma Concentration of Propofol-Remifentanil and Sevoflurane-Sufentanil |
Estimated Enrollment: | 100 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
propofol et remifentanil
|
Drug: Comparison of two anesthetics protocol
Comparison of two anesthetics protocol
|
2: Experimental
sevoflurane et sufentanil
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Drug: Comparison of two anesthetics protocol
Comparison of two anesthetics protocol
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Souhayl DAHMANI, MD | +33 (0)-1 40 87 59 11 | souhayl.dahmani@bjn.aphp.fr |
France | |
Centre Hospitalier Universitaire. | Recruiting |
BESANCON, France, 25030 CEDEX | |
Contact: Souhayl DAHMANI, MD,PhD +33 (0)-1 40 87 59 11 souhayl.dahmani@bjn.aphp.fr | |
Principal Investigator: Souhayl DAHMANI, MD | |
Hopital BEAUJON ASSISTANCE PUBLIQUE | Recruiting |
Clichy, France, 92110 | |
Contact: Souhayl DAHMANI, MD +33 (0)-1 40 87 59 11 souhayl.dahmani@bjn.aphp.fr | |
Principal Investigator: Souhayl DAHMANI, MD |
Principal Investigator: | Souhayl DAHMANI, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Reseach of Developpement ( Zakia IDIR ) |
Study ID Numbers: | P050320 |
Study First Received: | October 18, 2006 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00389883 |
Health Authority: | France: Ministry of Health |
supratentorial brain tumors propofol sevoflurane remifentanil sufentanil. |
Brain Neoplasms Remifentanil Central Nervous System Diseases Sufentanil Central Nervous System Neoplasms |
Propofol Brain Diseases Supratentorial Neoplasms Nervous System Neoplasms Sevoflurane |
Anesthetics, Intravenous Nervous System Diseases Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Neoplasms Neoplasms by Site |
Anesthetics, General Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |