Comparison of Different Propofol Formulations (Propofols)

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01041872
First received: December 31, 2009
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
General Anesthesia
Drug: Propofol Astrazeneca plain
Drug: Propofol Astrazeneca plus lidocaine
Drug: Propofol-lipuro B. Braun plain
Drug: Propofol-lipuro B. Braun plus lidocaine
Drug: Propofol Fresenius plain
Drug: Propofol Fresenius plus lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Lidocaine

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index of 50) [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • calculated concentrations of propofol at the end of the anesthetic induction [ Time Frame: end of the anesthetic induction ] [ Designated as safety issue: No ]
  • measured plasma propofol concentrations at the end of anesthetic induction (in 20% of patients) [ Time Frame: 3 months after the end of patient's recrutement ] [ Designated as safety issue: No ]
  • pain at injection [ Time Frame: during the PACU stay ] [ Designated as safety issue: No ]
  • heart rate and arterial pressure modifications induced by anesthetic induction [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]
  • patients satisfaction [ Time Frame: during the PACU stay ] [ Designated as safety issue: No ]
  • necessary dose of propofol to obtain loss of consciousness [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]
  • calculated concentrations of propofol at loss of consciousness [ Time Frame: end of anesthetic induction ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: December 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol Astrazeneca
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 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.
Other Name: Propofol Astrazeneca
Experimental: Propofol Astrazeneca plus lidocaine
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 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.
Other Name: Propofol Astrazeneca, Lidocaine
Experimental: Propofol-lipuro B. Braun plain
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 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.
Other Name: Propofol-lipuro B. Braun
Experimental: Propofol-lipuro B. Braun plus lidocaine
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 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.
Other Name: Propofol-lipuro B. Braun, lidocaine
Experimental: Propofol Fresenius plain
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 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.
Other Name: Propofol Fresenius
Experimental: Propofol Fresenius plus lidocaine
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
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.
Other Name: Propofol Fresenius, lidocaine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 lidocaine,
  • History of central neurological disorder or brain injury,
  • Patients receiving psychotropic drugs,
  • Patient with a pacemaker.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041872

Locations
France
Clinique Saint Augustin
Bordeaux, France, 33000
Laboratoire de Pharmacologie Toxicologie, hôpital Raymond Poincaré
Garches, France, 92380
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan LeGuen, MD Hôpital Foch
  More Information

Publications:
Responsible Party: Dr Marc Fischler, Hôpital Foch
ClinicalTrials.gov Identifier: NCT01041872     History of Changes
Other Study ID Numbers: 2009/22
Study First Received: December 31, 2009
Last Updated: July 18, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lidocaine
Propofol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on October 16, 2014