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Comparison of Different Propofol Formulations With or Without Remifentanil

Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01592162
Acronym
PropofolRemi
Enrollment
409
Registered
2012-05-07
Start date
2013-05-31
Completion date
2014-11-30
Last updated
2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

Interventions

DRUGPropofol (Astra-Zeneca), NaCl 0.9%

propofol administered by a closed-loop system and saline

DRUGpropofol 1% (Astra-Zeneca) and remifentanil

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

DRUGPropofol (Astra-Zeneca) and remifentanil

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

DRUGPropofol (B-Braun) and NaCl 0.9%

propofol administered by a closed-loop system and saline

DRUGPropofol (B-Braun) and remifentanil

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

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for an intravenous induction of anesthesia with propofol

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Disappearance of the eyelash reflexOne hour after anesthesia
pain at injectionone hour after anesthesia
calculated concentrations of propofol at the end of the anesthetic inductionone hour after anesthesia
patient's satisfactionone day after anesthesia
arterial pressure modifications induced by anesthetic inductionone hour after anesthesia
heart rate modifications induced by anesthetic inductionone hour after anesthesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026