NCT01041872

Brief Summary

The objective of this study is to evaluate the influence of different propofol formulations(plain or with lidocaine)on anesthetic induction. Propofol plain or with lidocaine is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
212

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

December 31, 2009

Last Update Submit

September 23, 2016

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50)

    end of anesthetic induction

Secondary Outcomes (7)

  • calculated concentrations of propofol at the end of the anesthetic induction

    end of the anesthetic induction

  • measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients)

    3 months after the end of patient's recruitment

  • pain at injection

    during the PACU (post-anaesthesia care unit) stay

  • heart rate and arterial pressure modifications induced by anesthetic induction

    end of anesthetic induction

  • patients satisfaction

    during the PACU stay

  • +2 more secondary outcomes

Study Arms (6)

Propofol Astrazeneca

ACTIVE COMPARATOR

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Drug: Propofol Astrazeneca plain

Propofol Astrazeneca plus lidocaine

EXPERIMENTAL

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Drug: Propofol Astrazeneca plus lidocaine

Propofol-lipuro B. Braun plain

EXPERIMENTAL

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Drug: Propofol-lipuro B. Braun plain

Propofol-lipuro B. Braun plus lidocaine

EXPERIMENTAL

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Drug: Propofol-lipuro B. Braun plus lidocaine

Propofol Fresenius plain

EXPERIMENTAL

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Drug: Propofol Fresenius plain

Propofol Fresenius plus lidocaine

EXPERIMENTAL

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Drug: Propofol Fresenius plus lidocaine

Interventions

Propofol Astrazeneca plainDRUG

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Also known as: Propofol Astrazeneca
Propofol Astrazeneca
Propofol Astrazeneca plus lidocaineDRUG

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Also known as: Propofol Astrazeneca, Lidocaine
Propofol Astrazeneca plus lidocaine
Propofol-lipuro B. Braun plainDRUG

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Also known as: Propofol-lipuro B. Braun
Propofol-lipuro B. Braun plain
Propofol-lipuro B. Braun plus lidocaineDRUG

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Also known as: Propofol-lipuro B. Braun, lidocaine
Propofol-lipuro B. Braun plus lidocaine
Propofol Fresenius plainDRUG

Propofol with saline is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of saline.

Also known as: Propofol Fresenius
Propofol Fresenius plain
Propofol Fresenius plus lidocaineDRUG

Propofol with lidocaine 1¨% is administered using a closed-loop algorithm which permits to reach a Bispectral Index target of 50. The blinded syringe contains 45 ml of propofol and 5 ml of lidocaine.

Also known as: Propofol Fresenius, lidocaine
Propofol Fresenius plus lidocaine

Eligibility Criteria

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

You may qualify if:

  • patients scheduled for an intravenous induction of anesthesia with propofol

You may not qualify if:

  • Age under 18
  • Pregnancy or breastfeeding
  • Allergy to propofol, soya or peanuts,
  • Allergy to lidocaine,
  • History of central neurological disorder or brain injury,
  • Patients receiving psychotropic drugs,
  • Patient with a pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinique Saint Augustin

Bordeaux, 33000, France

Location

Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré

Garches, 92380, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

Related Publications (1)

  • 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

MeSH Terms

Interventions

LidocainePropofol

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Morgan LeGuen, MD

    Hôpital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2009

First Posted

January 1, 2010

Study Start

December 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 26, 2016

Record last verified: 2016-09

Locations

FR(3)