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Ketamine and Closed-Loop Anesthesia System (LoopKeta)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02011347
Recruitment Status : Terminated
First Posted : December 13, 2013
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Tracking Information
First Submitted Date  ICMJE December 3, 2013
First Posted Date  ICMJE December 13, 2013
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE July 2013
Actual Primary Completion Date October 7, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2013)
  • bispectral index measurement [ Time Frame: 1 day ]
    bispectral index modification due to ketamine infusion before induction of anesthesia
  • administered dose of propofol during induction of anesthesia [ Time Frame: day 1 ]
  • administered doses of remifentanil during induction and maintenance of anesthesia [ Time Frame: day 1 ]
  • delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [ Time Frame: day 1 ]
  • hemodynamic abnormalities requiring treatment [ Time Frame: day 1 ]
  • % of time with a bispectral index between 40 and 60 [ Time Frame: day 1 ]
  • postoperative morphine requirement [ Time Frame: day 1 ]
  • incidence of postoperative nausea and vomiting [ Time Frame: day 1 ]
  • White and Song score [ Time Frame: day 1 ]
  • % of patients with an explicit memorisation of the intraoperative period [ Time Frame: second postoperative day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine and Closed-Loop Anesthesia System
Official Title  ICMJE Influence of Ketamine on a Closed-Loop Anesthesia System
Brief Summary The objective is to evaluate the sparing effect of ketamine on the dose of propofol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: Ketamine
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Ketamine
    Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Ketamine (bolus dose of Ketamine (0.15 mg.kg-1) followed by an infusion of Ketamine (0.15 mg.kg-1 h-1) until the end of anesthesia)
    Intervention: Drug: Ketamine
  • Experimental: Placebo
    patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo (NaCl 9/00 (same volume as in the Ketamine group)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
67
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2013)
90
Actual Study Completion Date  ICMJE October 7, 2015
Actual Primary Completion Date October 7, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with an American Society of Anesthesiology score 1, 2 or 3
  • scheduled for a surgical procedure lasting more than 2 hours under general anesthesia

Exclusion Criteria:

  • pregnancy
  • chronic pain
  • simultaneous general and loco-regional anesthesia
  • contra-indication to to nonsteroidal anti-inflammatory drug
  • contra-indication to Ketamine
  • contra-indication to propofol, to remifentanil, to morphine
  • history of central nervous system disease
  • patients receiving a psychotropic treatment
  • patients with a pace-maker
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02011347
Other Study ID Numbers  ICMJE 2012/26
2012-003001-97 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hopital Foch
Study Sponsor  ICMJE Hopital Foch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marc Fischler, MD Hôpital Foch
PRS Account Hopital Foch
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP