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Comparison of Different Propofol Formulations With or Without Remifentanil

Information source: Hopital Foch
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia

Intervention: Propofol (Astra-Zeneca), NaCl 0.9% (Drug); propofol 1% (Astra-Zeneca) and remifentanil (Drug); propofol 1% (Astra-Zeneca) and remifentanil (Drug); Propofol (Astra-Zeneca), NaCl 0.9% (Drug); Propofol (Astra-Zeneca) and remifentanil (Drug); Propofol (Astra-Zeneca) and remifentanil (Drug); Propofol (B-Braun) and NaCl 0.9% (Drug); Propofol (B-Braun) and remifentanil (Drug); Propofol (B-Braun) and remifentanil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hopital Foch

Official(s) and/or principal investigator(s):
Marc Fischler, MD, Study Chair, Affiliation: Hopital Foch

Overall contact:
Morgan Le Guen, MD, Phone: 46252442, Ext: 00331, Email: m.leguen@hopital-foch.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

calculated concentrations of propofol at the end of the anesthetic induction

pain at injection

heart rate modifications induced by anesthetic induction

patient's satisfaction

arterial pressure modifications induced by anesthetic induction

Disappearance of the eyelash reflex

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Morgan Le Guen, MD, Phone: 46252442, Ext: 00331, Email: m.leguen@hopital-foch.org

CHU Besançon, Besançon 25034, France; Recruiting
Nathalie Boichut, MD, Phone: 81 21 83 78, Ext: 00333, Email: nboichut@chu-besancon.fr
Nathalie Boichut, MD, Principal Investigator

Hopital Foch, Suresnes, Ile de France 92151, France; Recruiting
Morgan Le Guen, MD, Phone: 46252442, Ext: 00331, Email: m.leguen@hopital-foch.org
Morgan LeGuen, MD, Principal Investigator
Kerstin Sievert, MD, Sub-Investigator

Additional Information

Starting date: May 2013
Last updated: April 14, 2015

Page last updated: August 23, 2015

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