NCT00571181

Brief Summary

The purpose of this study is to compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during rigid bronchoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

December 9, 2007

Last Update Submit

September 22, 2016

Conditions

Anesthesia, General

Keywords

AlgorithmsAnesthesia, General/*methodsAnesthetics, Intravenous/*administration & dosageDrug Delivery Systems/*methods/statistics & numerical dataElectroencephalography/drug effects/*methods/Feasibility StudiesPropofol/*administration & dosageRemifentanil/*administration & dosageBronchoscopy/*methodsProspective StudiesSoftware

Outcome Measures

Primary Outcomes (1)

  • Percentage of time with BIS in the desired range

    During the procedure

Secondary Outcomes (3)

  • consumption of propofol and remifentanil

    during the procedure

  • extubation time

    during the procedure

  • explicit memorisation

    postoperative day 2

Study Arms (2)

1

EXPERIMENTAL
Device: Closed-loop system

2

ACTIVE COMPARATOR
Device: TCI (Infusion Toolbox)

Interventions

Closed-loop systemDEVICE

Automatic delivery of propofol and remifentanil

1
TCI (Infusion Toolbox)DEVICE

TCI administration of propofol and remifentanil

2

Eligibility Criteria

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

You may qualify if:

  • patients undergoing rigid bronchoscopy under general anesthesia

You may not qualify if:

  • pregnant women
  • allergy to propofol or remifentanil
  • neurological disorder
  • psychotrop treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie, Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (3)

  • Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9. doi: 10.1017/S0265021506000196.

    PMID: 16672092BACKGROUND

  • Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

    PMID: 16571963BACKGROUND

  • Liu N, Pruszkowski O, Leroy JE, Chazot T, Trillat B, Colchen A, Gonin F, Fischler M. Automatic administration of propofol and remifentanil guided by the bispectral index during rigid bronchoscopic procedures: a randomized trial. Can J Anaesth. 2013 Sep;60(9):881-7. doi: 10.1007/s12630-013-9986-7. Epub 2013 Jul 16.

    PMID: 23857041DERIVED

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2007

First Posted

December 11, 2007

Study Start

December 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)