---
title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
nct_id: NCT03816592
overall_status: COMPLETED
sponsor: Centre Hospitalier Universitaire Dijon
study_type: OBSERVATIONAL
primary_condition: Opioid Free Anaesthesia
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03816592.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03816592"
ct_last_update_post_date: 2026-02-04
last_seen_at: "2026-05-12T07:20:39.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

**Official Title:** Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

**NCT ID:** [NCT03816592](https://clinicaltrials.gov/study/NCT03816592)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** Centre Hospitalier Universitaire Dijon
- **Conditions:** Opioid Free Anaesthesia, Opioid Anaesthesia
- **Start Date:** 2019-01-01
- **Completion Date:** 2019-03-31
- **CT.gov Last Update:** 2026-02-04

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Opioid free anaesthesia** — patient anesthtesized with lidocaine, ketamine and dexamethasone
- **Opioid anaesthesia** — patients anesthetized with sufentanil ketamine and dexamethasone

## Interventions

- **Opioid free anaesthesia** (PROCEDURE) — patient anesthtesized with lidocaine, ketamine and dexamethasone
- **Opioid anaesthesia** (PROCEDURE) — patients anesthetized with sufentanil ketamine and dexamethasone

## Primary Outcomes

- **Morphine consumption** _(time frame: Day 2)_ — Total morphine consumption over the first 48 post operative hours in milligrammes
- **Complications** _(time frame: Day 7)_ — composite end point of post operative complications (cardiac, neurological, renal, respiratory)

## Locations (1)

- Chu Dijon Bourogne, Dijon, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu dijon bourogne|dijon||france` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03816592*  
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