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Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03816592
Acronym
OFACAR 1
Enrollment
110
Registered
2019-01-25
Start date
2019-01-01
Completion date
2019-03-31
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Free Anaesthesia, Opioid Anaesthesia

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).

Interventions

patient anesthtesized with lidocaine, ketamine and dexamethasone

patients anesthetized with sufentanil ketamine and dexamethasone

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumptionDay 2Total morphine consumption over the first 48 post operative hours in milligrammes
ComplicationsDay 7composite end point of post operative complications (cardiac, neurological, renal, respiratory)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026