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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

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).

Condition or disease Intervention/treatment
Opioid Free Anaesthesia Opioid Anaesthesia Procedure: Opioid free anaesthesia Procedure: Opioid anaesthesia

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Opioid free anaesthesia
patient anesthtesized with lidocaine, ketamine and dexamethasone
Procedure: Opioid free anaesthesia
patient anesthtesized with lidocaine, ketamine and dexamethasone

Opioid anaesthesia
patients anesthetized with sufentanil ketamine and dexamethasone
Procedure: Opioid anaesthesia
patients anesthetized with sufentanil ketamine and dexamethasone




Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: Day 2 ]
    Total morphine consumption over the first 48 post operative hours in milligrammes

  2. Complications [ Time Frame: Day 7 ]
    composite end point of post operative complications (cardiac, neurological, renal, respiratory)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac surgical
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816592


Locations
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France
Chu Dijon Bourogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03816592    
Other Study ID Numbers: GUINOT 2019
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Analgesics, Opioid
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents