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Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass (OFACAR 1)

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: NCT03816592
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date January 22, 2019
First Posted Date January 25, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date January 1, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2019)
  • Morphine consumption [ Time Frame: Day 2 ]
    Total morphine consumption over the first 48 post operative hours in milligrammes
  • Complications [ Time Frame: Day 7 ]
    composite end point of post operative complications (cardiac, neurological, renal, respiratory)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
Official Title Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
Brief Summary Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cardiac surgical
Condition
  • Opioid Free Anaesthesia
  • Opioid Anaesthesia
Intervention
  • Procedure: Opioid free anaesthesia
    patient anesthtesized with lidocaine, ketamine and dexamethasone
  • Procedure: Opioid anaesthesia
    patients anesthetized with sufentanil ketamine and dexamethasone
Study Groups/Cohorts
  • Opioid free anaesthesia
    patient anesthtesized with lidocaine, ketamine and dexamethasone
    Intervention: Procedure: Opioid free anaesthesia
  • Opioid anaesthesia
    patients anesthetized with sufentanil ketamine and dexamethasone
    Intervention: Procedure: Opioid anaesthesia
Publications * Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 22, 2019)
110
Original Estimated Enrollment Same as current
Actual Study Completion Date March 31, 2019
Actual Primary Completion Date March 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age over 18 years
  • cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • patient with chronic analgesia treatment
  • patient on antidepressive therapy
  • gabapentin use
  • preoperative cognitive dysfunction
  • patient treated with zyvoxid
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03816592
Other Study ID Numbers GUINOT 2019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date January 2019