NCT00389883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

October 18, 2006

Last Update Submit

July 6, 2012

Conditions

Supratentorial Neoplasms

Keywords

supratentorial brain tumorspropofolsevofluraneremifentanilsufentanil.

Outcome Measures

Primary Outcomes (1)

  • Time from discontinuing anesthesia and extubation.

    during 24 hours

Secondary Outcomes (3)

  • 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

  • Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.

    during 24 hours

  • Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.

    during 24 hours

Study Arms (2)

1

ACTIVE COMPARATOR

propofol et remifentanil

Drug: Comparison of two anesthetics protocol

2

EXPERIMENTAL

sevoflurane et sufentanil

Drug: Comparison of two anesthetics protocol

Interventions

Comparison of two anesthetics protocolDRUG

Comparison of two anesthetics protocol

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient scheduled for supratentorial brain tumors remove.
  • Age : 18 to 75.
  • ASA 1 or 2.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire.

Besançon, 25030 CEDEX, France

Location

Hopital BEAUJON ASSISTANCE PUBLIQUE

Clichy, 92110, France

Location

Related Publications (2)

  • 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.

    PMID: 8512094RESULT

  • 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.

    PMID: 23774117DERIVED

MeSH Terms

Conditions

Supratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Souhayl DAHMANI, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

November 1, 2006

Primary Completion

January 1, 2010

Study Completion

November 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

FR(2)