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 inductionpain 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
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