Anaesthesia for Supratentorial Tumor Resection

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Supratentorial Neoplasms

Treatments: Drug: Comparison of two anesthetics protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00389883

P050320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

69 participants in 2 patient groups

1

Active Comparator group

Description:

propofol et remifentanil

Treatment:

Drug: Comparison of two anesthetics protocol

2

Experimental group

Description:

sevoflurane et sufentanil

Treatment:

Drug: Comparison of two anesthetics protocol