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Anaesthesia for Supratentorial Tumor Resection

Primary Purpose

Supratentorial Neoplasms

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Comparison of two anesthetics protocol
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supratentorial Neoplasms focused on measuring supratentorial brain tumors, propofol, sevoflurane, remifentanil, sufentanil.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Hospitalier Universitaire.
  • Hopital BEAUJON ASSISTANCE PUBLIQUE

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

propofol et remifentanil

sevoflurane et sufentanil

Outcomes

Primary Outcome Measures

Time from discontinuing anesthesia and extubation.

Secondary Outcome Measures

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.
Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.
Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.

Full Information

First Posted
October 18, 2006
Last Updated
July 6, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00389883
Brief Title
Anaesthesia for Supratentorial Tumor Resection
Official Title
Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Neoplasms
Keywords
supratentorial brain tumors, propofol, sevoflurane, remifentanil, sufentanil.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
propofol et remifentanil
Arm Title
2
Arm Type
Experimental
Arm Description
sevoflurane et sufentanil
Intervention Type
Drug
Intervention Name(s)
Comparison of two anesthetics protocol
Intervention Description
Comparison of two anesthetics protocol
Primary Outcome Measure Information:
Title
Time from discontinuing anesthesia and extubation.
Time Frame
during 24 hours
Secondary Outcome Measure Information:
Title
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.
Time Frame
during 24 hours
Title
Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.
Time Frame
during 24 hours
Title
Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.
Time Frame
during 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Souhayl DAHMANI, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire.
City
Besancon
ZIP/Postal Code
25030 CEDEX
Country
France
Facility Name
Hopital BEAUJON ASSISTANCE PUBLIQUE
City
Clichy
ZIP/Postal Code
92110
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
8512094
Citation
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.
Results Reference
result
PubMed Identifier
23774117
Citation
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.
Results Reference
derived

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Anaesthesia for Supratentorial Tumor Resection

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