Anaesthesia for Supratentorial Tumor Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00389883
First received: October 18, 2006
Last updated: July 6, 2012
Last verified: July 2012
  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 Neoplasms
Drug: Comparison of two anesthetics protocol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ]

Enrollment: 69
Study Start Date: November 2006
Study Completion Date: November 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
propofol et remifentanil
Drug: Comparison of two anesthetics protocol
Comparison of two anesthetics protocol
Other Name: Comparison of two anesthetics protocol
Experimental: 2
sevoflurane et sufentanil
Drug: Comparison of two anesthetics protocol
Comparison of two anesthetics protocol
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00389883     History of Changes
Other Study ID Numbers: P050320
Study First Received: October 18, 2006
Last Updated: July 6, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
supratentorial brain tumors
propofol
sevoflurane
remifentanil
sufentanil.

Additional relevant MeSH terms:
Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anesthetics
Propofol
Sevoflurane
Remifentanil
Sufentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014