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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05136794
Other study ID # GUINOT 2021-4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date January 15, 2022

Study information

Verified date February 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.


Recruitment information / eligibility

Status Completed
Enrollment 1772
Est. completion date January 15, 2022
Est. primary completion date January 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021 Exclusion Criteria: LVAD Heart transplantation Incomplete data in relation to outcomes

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay

Locations

Country Name City State
France Chu Dijon Bourgogne 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 ICU stays (days) Total stay in ICU in day Day 30
Secondary Complications cardiac, neurological, renal, respiratory, red blood transfusion Day 30
Secondary Hospital stays (days) hospital stay Day 30
See also
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Completed NCT03120234 - Comparison of Opioid Based and Opioid Free Anaesthesia in Transsphenoidal Surgery N/A
Completed NCT03816592 - Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
Recruiting NCT06404983 - Opioid-free Anaesthesia in Breast Cancer Surgery N/A