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Anaesthesia for Supratentorial Tumor Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00389883
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Supratentorial Neoplasms Drug: Comparison of two anesthetics protocol Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil
Study Start Date : November 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : November 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
propofol et remifentanil
 Drug: Comparison of two anesthetics protocol
Comparison of two anesthetics protocol
Experimental: 2
sevoflurane et sufentanil
 Drug: Comparison of two anesthetics protocol
Comparison of two anesthetics protocol


Outcome Measures
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Primary Outcome Measures :
  1. Time from discontinuing anesthesia and extubation. [ Time Frame: during 24 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions. [ Time Frame: during 24 hours ]
  3. Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties. [ Time Frame: during 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389883


Locations
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France
Centre Hospitalier Universitaire.
Besancon, France, 25030 CEDEX
Hopital BEAUJON ASSISTANCE PUBLIQUE
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Souhayl DAHMANI, MD,PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00389883    
Other Study ID Numbers: P050320
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
supratentorial brain tumors
propofol
sevoflurane
remifentanil
sufentanil.
Additional relevant MeSH terms:
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Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs