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

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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

Study Description

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

Study Design

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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

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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)

Eligibility Criteria

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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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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

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