Anaesthesia for Supratentorial Tumor Resection

Supratentorial Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389883
• Other study ID #: P050320
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2006
• Last updated: July 6, 2012
• Start date: November 2006
• Est. completion date: November 2011

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Supratentorial Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire.	Besancon
France	Hopital BEAUJON ASSISTANCE PUBLIQUE	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Anesthes — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from discontinuing anesthesia and extubation.		during 24 hours	Yes
Secondary	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.		during 24 hours	Yes
Secondary	Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.		during 24 hours	Yes
Secondary	Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.		during 24 hours	Yes