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Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil


Phase 3
18 Years
75 Years
Not Enrolling
Both
Supratentorial Neoplasms

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Trial Information

Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time from discontinuing anesthesia and extubation.

Outcome Time Frame:

during 24 hours

Safety Issue:

Yes

Principal Investigator

Souhayl DAHMANI, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P050320

NCT ID:

NCT00389883

Start Date:

November 2006

Completion Date:

November 2011

Related Keywords:

  • Supratentorial Neoplasms
  • supratentorial brain tumors
  • propofol
  • sevoflurane
  • remifentanil
  • sufentanil.
  • Neoplasms
  • Supratentorial Neoplasms

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