Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389883
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2006-10-18
Brief Title:
Anaesthesia for Supratentorial Tumor Resection
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Anaesthesia for Supratentorial Tumor Resection a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None