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

• ClinicalTrials.gov Identifier: NCT03816592
• Recruitment Status: Completed
• First Posted: January 25, 2019
• Last Update Posted: May 21, 2019
• Sponsor: Centre Hospitalier Universitaire Dijon
• 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
• 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.

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

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