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Factors Influencing Anesthetic Drug Requirement (PosoAnes)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00896714
First received: May 8, 2009
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
The main objective of the study is to analyze the influence of several environmental (i.e., timing: seasonal, circadian) and demographic conditions (i.e., age, gender, menstrual cycle) on anesthetic drug requirements (hypnotic and opiate).

Condition Intervention Phase
Anesthesia, General
Device: Closed loop anesthesia
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Environmental and Demographic Factors on Pre-operative Doses of Anesthetic Agents (Prospective Multicenter Study)

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • The dose of propofol required to maintain BIS (bispectral index) between 40 and 60 during maintenance of anesthesia [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Propofol dose required for anesthesia induction [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
  • Remifentanil dose required for anesthesia induction [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
  • Remifentanil dose requirements for maintenance of anesthesia [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
  • Wake up time [ Time Frame: intraoperative period ] [ Designated as safety issue: No ]
  • Explicit memorisation [ Time Frame: post-operative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: May 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closed loop anesthesia Device: Closed loop anesthesia
Propofol and Remifentanil are administered automatically using a closed-loop system

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing scheduled surgery under general anesthesia, agreeing to participate in the study

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy, breastfeeding woman
  • Allergy to propofol, soybeans or peanuts
  • Allergy to sufentanil, remifentanil, morphine,
  • Allergy to a muscle relaxant or to any of its excipients
  • Known hypersensitivity to sufentanil, remifentanil, or to other derivates of fentanyl
  • History of central neurological disorder or brain injury
  • Patient with dementia
  • Patient with pacemaker
  • Patient receiving psychotropic drugs or morphine agonist-antagonists
  • Surgery on the skull and/or operating position preventing the use of a bispectral index sensor in suitable conditions
  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: NCT00896714

Locations
France
Clinique de la Baie des Citrons
Nouméa, Nouvelle Calédonie, France, 98800
CHU Besançon
Besançon, France, 25000
Centre Hospitalier de Dreux
Dreux, France, 28102
Hôpital Tenon
Paris, France, 75020
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT00896714     History of Changes
Other Study ID Numbers: 2008/44 
Study First Received: May 8, 2009
Last Updated: September 22, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 28, 2016