Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass (LISRACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05136794
Recruitment Status : Not yet recruiting
First Posted : November 29, 2021
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.

Condition or disease Intervention/treatment
Opioid Free Anaesthesia Opioid Anaesthesia Other: Data collection

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1800 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Opioid free anaesthesia
patient anesthtesized with lidocaine
Other: Data collection
complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay

Opioid anaesthesia
patients anesthetized with sufentanil
Other: Data collection
complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay




Primary Outcome Measures :
  1. ICU stays (days) [ Time Frame: Day 30 ]
    Total stay in ICU in day


Secondary Outcome Measures :
  1. Complications [ Time Frame: Day 30 ]
    cardiac, neurological, renal, respiratory, red blood transfusion

  2. Hospital stays (days) [ Time Frame: Day 30 ]
    hospital stay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 performed between January 2019 and June 2021

Exclusion Criteria:

LVAD Heart transplantation Incomplete data in relation to outcomes


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): NCT05136794


Contacts
Layout table for location contacts
Contact: Pierre-Grégoire Guinot 03.80.28.13. 09 guinotpierregregoire@gmail.com

Locations
Layout table for location information
France
Chu Dijon Bourgogne
Dijon, France
Contact: Pierre-Grégoire GUINOT    03.80.28.13. 09    guinotpierregregoire@gmail.com   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT05136794    
Other Study ID Numbers: GUINOT 2021-4
First Posted: November 29, 2021    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No