Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002126-90 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The use of morphine derivatives is widespread for performing general anesthesia. However, opioids have their own side effects: respiratory depression, digestive ileus, cognitive dysfunction, postoperative hyperalgesia, nausea-vomiting or even negative effects on inflammation or adrenal function. The advent of new molecules, with analgesic properties that do not pass through opioid receptors, has allowed the emergence of the concept of anesthesia without morphine (opioid free anesthesia OFA). These molecules are essentially: dexmedetomidine, ketamine, lidocaine. Thus, the use of ketamine is currently recommended in the event of major surgery in order to limit postoperative pain and hyperalgesia. Likewise, the use of dexmedetomidine in place of an opioid during bariatric surgeries has been shown to reduce postoperative pain and intraoperative hemodynamic manifestations. In addition, it would also reduce the incidence of postoperative cognitive dysfunction. A recent meta-analysis even suggested a decrease in length of stay, mechanical ventilation, atrial fibrillation and mortality with the use of dexmedetomidine in the perioperative period. The combined use of various non-morphine analgesic molecules therefore opens the way to anesthesia without morphine, and a French multicenter study on this strategy in general non-cardiac surgery is currently underway. Cardiac surgery is characterized by significant postoperative pain, a high incidence of cognitive dysfunction, and frequent and sometimes significant respiratory complications. An OFA strategy could therefore be beneficial to these patients, but no study has yet addressed the subject.
The objective of our work is therefore to assess the beneficial effects of OFA versus strategy with intraoperative opioids on postoperative complications related to opioids.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm | Active Comparator | General anesthesia strategy with morphine:
|
|
| OFA arm | Experimental | General anesthesia strategy without morphine
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg | Drug | The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of general anesthesia strategy without the use of opioids (OFA) on the incidence of major postoperative complications related to opioids compared to the reference strategy using opioids. | Composite criterion consisting of the appearance 48 hours after the surgery of an intestinal ileus, and / or of an alteration of the neurological state, and / or of an acute respiratory failure, and / or of a death | 48 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of OFA on the incidence of postoperative nausea and vomiting. | Existence of post-surgery nausea | 48 hours post-surgery |
| To assess the impact of OFA on the incidence of postsurgery pain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rouen University Hospital | Rouen | France, Normandy | 76031 | France | ||
| Amiens Univesrity Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38830745 | Derived | Besnier E, Moussa MD, Thill C, Vallin F, Donnadieu N, Ruault S, Lorne E, Scherrer V, Lanoiselee J, Lefebvre T, Sentenac P, Abou-Arab O. Opioid-free anaesthesia with dexmedetomidine and lidocaine versus remifentanil-based anaesthesia in cardiac surgery: study protocol of a French randomised, multicentre and single-blinded OFACS trial. BMJ Open. 2024 Jun 3;14(6):e079984. doi: 10.1136/bmjopen-2023-079984. |
Not provided
Not provided
Data generated by this trial will not be publicly available but upon reasonable request to the corresponding author (Emmanuel Besnier, emmanuel.besnier@chu-rouen.fr). In this case, data will be totally deidentified. Requesters should provide a structured and detailed protocol for the proposed study and the reasons for reusing data.
From results publication to 10 years
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Remifentanil | Drug | The patient will be anesthetized with morphin. |
|
|
Number of post-surgery pain episodes at rest (VAS ≥ 3) and total morphine consumption
| 48 hours post-surgery |
| To assess the impact of OFA on the incidence of atrial rhythm disturbances and / or ventricular postsurgery shock states. | Appearance of non-preexisting atrial fibrillation and/or of postsurgery ventricular rhythm disturbances and/or high degree cardiac conduction disorders | 48 hours post-surgery |
| To assess the impact of OFA on the incidence of acute post-surgery renal failure, | Onset of acute renal failure defined by a KDIGO score ≥ 1 | 48 hours post-surgery |
| To assess the impact of the OFA on the incidence of post-surgery adrenal insufficiency, | Incidence of relative adrenal insufficiency 24 hours postoperatively by performing a synacthene test. An increase in cortisol levels <250 nmol / L within one hour of the injection of 250 µg of tetracosactide is a diagnosis | 24 hours post-surgery |
| Evaluate the impact of the OFA on the impact of the length of ICU and hospital stay Evaluate the impact of the OFA on the impact of the length of post-surgeryhospital stay | Number of days in the hospital | Within 2 months after surgery |
| Evaluate the impact of the OFA on the incidence of postoperative mortality | Number of deaths | Within 2 months after surgery |
| Persistence of chronic pain evaluated during a telephone call | simple numerical scale, from 0 to 10 | 3 months after surgery |
| Persistence of chronic pain evaluated during a telephone call | neuropatic pain questionnaire (DN4), from 0 to 10 | 3 months after surgery |
| To assess the impact of OFA on the incidence of shock | Presence of cardiogenic shock and vasoplegic syndrome | 48 hours post-surgery |
| To assess the myocardial pain | maximum troponin plasma level | 48 hours post-surgery |
| To assess the intraoperative safety | Existence of bradycardia requiring atropine adminitsrtation and/or appearance of arterial hypotension or hypertension | intraoperative periode |
| Amiens |
| France |
| CAEN university Hospital | Caen | France |
| Lille Hopistal University | Lille | France |
| Montpellier University Hospital | Montpellier | France |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |