NCT01592162

Brief Summary

The objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil 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
409

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2013

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

April 17, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1.5 years

First QC Date

April 17, 2012

Last Update Submit

November 2, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)

    one hour after anesthesia

Secondary Outcomes (6)

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

    one hour after anesthesia

  • pain at injection

    one hour after anesthesia

  • heart rate modifications induced by anesthetic induction

    one hour after anesthesia

  • patient's satisfaction

    one day after anesthesia

  • arterial pressure modifications induced by anesthetic induction

    one hour after anesthesia

  • +1 more secondary outcomes

Study Arms (9)

propofol 1% (Astra-Zeneca) - remi 0

ACTIVE COMPARATOR

propofol 1% (Astra-Zeneca)plus remifentanil 0 ng/ml

Drug: Propofol (Astra-Zeneca), NaCl 0.9%

propofol 1% (Astra-Zeneca) - remi 2

ACTIVE COMPARATOR

propofol 1% (Astra-Zeneca)plus remifentanil 2 ng/ml

Drug: propofol 1% (Astra-Zeneca) and remifentanil

propofol 1% (Astra-Zeneca) - remi 4

ACTIVE COMPARATOR

propofol 1% (Astra-Zeneca)plus remifentanil 4 ng/ml

Drug: propofol 1% (Astra-Zeneca) and remifentanil

propofol 1% (Fresenius) - remi 0

ACTIVE COMPARATOR

propofol 1% (Fresenius) plus remifentanil 0 ng/ml

Drug: Propofol (Astra-Zeneca), NaCl 0.9%

propofol 1% (Fresenius) - remi 2

ACTIVE COMPARATOR

propofol 1% (Fresenius) plus remifentanil 2 ng/ml

Drug: Propofol (Astra-Zeneca) and remifentanil

propofol 1% (Fresenius) - remi 4

ACTIVE COMPARATOR

propofol 1% (Fresenius) plus remifentanil 4 ng/ml

Drug: Propofol (Astra-Zeneca) and remifentanil

propofol 1% (B-Braun) - remi 0

ACTIVE COMPARATOR

propofol 1% (B-Braun) plus remifentanil 0 ng/ml

Drug: Propofol (B-Braun) and NaCl 0.9%

propofol 1% (B-Braun) - remi 2

ACTIVE COMPARATOR

propofol 1% (B-Braun) plus remifentanil 2 ng/ml

Drug: Propofol (B-Braun) and remifentanil

propofol 1% (B-Braun) - remi 4

ACTIVE COMPARATOR

propofol 1% (B-Braun) plus remifentanil 4 ng/ml

Drug: Propofol (B-Braun) and remifentanil

Interventions

Propofol (Astra-Zeneca), NaCl 0.9%DRUG

propofol administered by a closed-loop system and saline

propofol 1% (Astra-Zeneca) - remi 0
propofol 1% (Astra-Zeneca) and remifentanilDRUG

propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)

propofol 1% (Astra-Zeneca) - remi 2
Propofol (Astra-Zeneca) and remifentanilDRUG

propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)

propofol 1% (Fresenius) - remi 2
Propofol (B-Braun) and NaCl 0.9%DRUG

propofol administered by a closed-loop system and saline

propofol 1% (B-Braun) - remi 0
Propofol (B-Braun) and remifentanilDRUG

propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)

propofol 1% (B-Braun) - remi 2

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 remifentanil,
  • 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 (2)

CHU Besançon

Besançon, 25034, France

Location

Hopital Foch

Suresnes, Île-de-France Region, 92151, France

Location

MeSH Terms

Interventions

PropofolSodium ChlorideRemifentanilSaline Solution

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 17, 2012

First Posted

May 7, 2012

Study Start

May 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(2)