NCT05136794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,772

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

November 16, 2021

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • ICU stays (days)

    Total stay in ICU in day

    Day 30

Secondary Outcomes (2)

  • Complications

    Day 30

  • Hospital stays (days)

    Day 30

Study Arms (2)

Opioid free anaesthesia

patient anesthtesized with lidocaine

Other: Data collection

Opioid anaesthesia

patients anesthetized with sufentanil

Other: Data collection

Interventions

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

Opioid anaesthesiaOpioid free anaesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac surgical

You may qualify if:

  • age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021

You may not qualify if:

  • LVAD Heart transplantation Incomplete data in relation to outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

Related Publications (1)

  • Guinot PG, Andrei S, Durand B, Martin A, Duclos V, Spitz A, Berthoud V, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Nguyen M, Bouhemad B. Balanced Nonopioid General Anesthesia With Lidocaine Is Associated With Lower Postoperative Complications Compared With Balanced Opioid General Anesthesia With Sufentanil for Cardiac Surgery With Cardiopulmonary Bypass: A Propensity Matched Cohort Study. Anesth Analg. 2023 May 1;136(5):965-974. doi: 10.1213/ANE.0000000000006383. Epub 2023 Feb 10.

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 29, 2021

Study Start

December 1, 2021

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations