Anaesthesia for Supratentorial Tumor Resection - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00389883

Purpose

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

MedlinePlus related topics: Anesthesia Brain Cancer Cancer Nausea and Vomiting

Drug Information available for: Propofol Sufentanil Sufentanil citrate Sevoflurane Remifentanil Remifentanil hydrochloride

U.S. FDA Resources

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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Time from discontinuing anesthesia and extubation. [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]
Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions. [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]
Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties. [ Time Frame: during 24 hours ] [ Designated as safety issue: Yes ]

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	Drug: Comparison of two anesthetics protocol Comparison of two anesthetics protocol

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389883

Contacts

Contact: Souhayl DAHMANI, MD

+33 (0)-1 40 87 59 11

souhayl.dahmani@bjn.aphp.fr

Locations

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

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Souhayl DAHMANI, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

Publications of Results:

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.

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:

supratentorial brain tumors
propofol
sevoflurane
remifentanil
sufentanil.

Study placed in the following topic categories:

Brain Neoplasms
Remifentanil
Central Nervous System Diseases
Sufentanil
Central Nervous System Neoplasms

Propofol
Brain Diseases
Supratentorial Neoplasms
Nervous System Neoplasms
Sevoflurane

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009