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Anaesthesia for Supratentorial Tumor Resection

NCT ID: NCT00389883

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Supratentorial Neoplasms

Keywords

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supratentorial brain tumors propofol sevoflurane remifentanil sufentanil.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

propofol et remifentanil

Group Type ACTIVE_COMPARATOR

Comparison of two anesthetics protocol

Intervention Type DRUG

Comparison of two anesthetics protocol

2

sevoflurane et sufentanil

Group Type EXPERIMENTAL

Comparison of two anesthetics protocol

Intervention Type DRUG

Comparison of two anesthetics protocol

Interventions

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Comparison of two anesthetics protocol

Comparison of two anesthetics protocol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Souhayl DAHMANI, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Centre Hospitalier Universitaire.

Besançon, , France

Site Status

Hopital BEAUJON ASSISTANCE PUBLIQUE

Clichy, , France

Site Status

Countries

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France

References

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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. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.

Reference Type RESULT
PMID: 8512094 (View on PubMed)

Necib S, Tubach F, Peuch C, LeBihan E, Samain E, Mantz J, Dahmani S; PROMIFLUNIL trial group. Recovery from anesthesia after craniotomy for supratentorial tumors: comparison of propofol-remifentanil and sevoflurane-sufentanil (the PROMIFLUNIL trial). J Neurosurg Anesthesiol. 2014 Jan;26(1):37-44. doi: 10.1097/ANA.0b013e31829cc2d6.

Reference Type DERIVED
PMID: 23774117 (View on PubMed)

Other Identifiers

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P050320

Identifier Type: -

Identifier Source: org_study_id