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Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

NCT04886453 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2024-05-17

No results posted yet for this study

Summary

Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:

* better analgesia and decreased postoperative morphine consumption,
* better respiratory function,
* better hemodynamic stability,
* better postoperative cognitive function.

The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:

* Improved intraoperative hemodynamic stability
* A decrease in the incidence of postoperative complications
* A reduction in intensive care and hospital length of stay

Conditions

  • Opioid-free Anesthesia
  • Cardiac Surgery

Interventions

DRUG

Balanced general anesthesia without morphine

Balanced general anesthesia without morphine

DRUG

Standard general anesthesia balanced with morphine

Standard general anesthesia balanced with morphine

OTHER

Data collection

Data collection

OTHER

Assessment of pain

visual analog scale

OTHER

Recovery quality score

QoR15 questionnaire

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2024-03-21
Completion
2024-03-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04886453 on ClinicalTrials.gov