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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03816592
Other study ID # GUINOT 2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 31, 2019

Study information

Verified date January 2019
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Opioid free anaesthesia
patient anesthtesized with lidocaine, ketamine and dexamethasone
Opioid anaesthesia
patients anesthetized with sufentanil ketamine and dexamethasone

Locations

Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Morphine consumption Total morphine consumption over the first 48 post operative hours in milligrammes Day 2
Primary Complications composite end point of post operative complications (cardiac, neurological, renal, respiratory) Day 7
See also
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Completed NCT05136794 - LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass