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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | propofol et remifentanil |
|
| 2 | Experimental | sevoflurane et sufentanil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of two anesthetics protocol | Drug | Comparison of two anesthetics protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from discontinuing anesthesia and extubation. | during 24 hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Souhayl DAHMANI, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire. | Besançon | 25030 CEDEX | France | |||
| Hopital BEAUJON ASSISTANCE PUBLIQUE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8512094 | Result | Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002. | |
| 23774117 |
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| ID | Term |
|---|---|
| D015173 | Supratentorial Neoplasms |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| during 24 hours |
| Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties. | during 24 hours |
| Clichy |
| 92110 |
| France |
| Necib S, Tubach F, Peuch C, LeBihan E, Samain E, Mantz J, Dahmani S; PROMIFLUNIL trial group. Recovery from anesthesia after craniotomy for supratentorial tumors: comparison of propofol-remifentanil and sevoflurane-sufentanil (the PROMIFLUNIL trial). J Neurosurg Anesthesiol. 2014 Jan;26(1):37-44. doi: 10.1097/ANA.0b013e31829cc2d6. |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |