Opioid-Free Anesthesia in Cardiac Surgery

Anesthesia Clinical Trial

— OFACS  

Official title:

Opioid-Free Anesthesia in Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940689
• Other study ID #: 2019/0399/HP
• Status: Recruiting
• Phase: Phase 3
• Start date: July 22, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Rouen
• Contact: Emmanuel Besnier, MD, PhD
• Phone: +3323288
• Email: emmanuel.besnier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients having planned cardiac surgery under cardiopulmonary bypass, with at least one coronary artery bypass grafting and rf at least one internal mammary artery as graft; possible association with aortic valve replacement

• Patient having red and understood the information letter and signed the consent form

• For women : of childbearing age, need to confirm the absence of an active pregnancy by a negative blood pregnancy test within 48 hours prior to inclusion / menopausal (amenorrhea not medically induced for at least 12 months before the inclusion visit)

• Patient affiliated to a social security scheme

Exclusion Criteria:

• Preoperative treatment with morphine or its derivatives (including tramadol) in the 15 days preceding the inclusion visit

• Pre-existing high-degree conduction disorder

• Bradycardia < 50 bpm

• Oxygen therapy prior to inclusion

• Heart failure with LVEF <40%

• BMI = 35 kg/m²

• Myocardial suffering in the 5 days preceding inclusion

• Patient in shock

• Known adrenal insufficiency and / or long-term systemic corticosteroid treatment (equivalent to hydrocortisone hemisuccinate = 20 mg / day)

• Combined surgery other than aortic valve

• Long-term non-invasive ventilation (including for obstructive sleep apnea syndrome)

• Any antecedent or active practice (s) of drug addiction;

• Contraindication to one of the experimental and / or non-experimental treatments:

dexmedetomidine, lidocaine, dexamethasone, ketamine, remifentanil or morphine

• Acute cerebrovascular pathology,

• Severe hepatic insufficiency (factor V level <50%),

• Pre-existing cognitive disorders,

• Patient for whom the CAM-ICU questionnaire cannot be carried out (deaf patients for example),

• Pregnant or parturient or breastfeeding woman

• Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / under guardianship or guardianship

• Patient participating in another drug trial or having participated in another drug trial within 1 month before randomization

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg
The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin.
• Remifentanil
The patient will be anesthetized with morphin.

Locations

Country	Name	City	State
France	Amiens Univesrity Hospital	Amiens
France	CAEN university Hospital	Caen
France	Lille Hopistal University	Lille
France	Montpellier University Hospital	Montpellier
France	Rouen University Hospital	Rouen	France, Normandy

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To assess the impact of OFA on the incidence of postoperative nausea and vomiting.	Existence of post-surgery nausea	48 hours post-surgery
Secondary	To assess the impact of OFA on the incidence of postsurgery pain.	Number of post-surgery pain episodes at rest (VAS = 3) and total morphine consumption	48 hours post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the impact of the OFA on the incidence of postoperative mortality	Number of deaths	Within 2 months after surgery
Secondary	Persistence of chronic pain evaluated during a telephone call	simple numerical scale, from 0 to 10	3 months after surgery
Secondary	Persistence of chronic pain evaluated during a telephone call	neuropatic pain questionnaire (DN4), from 0 to 10	3 months after surgery
Secondary	To assess the impact of OFA on the incidence of shock	Presence of cardiogenic shock and vasoplegic syndrome	48 hours post-surgery
Secondary	To assess the myocardial pain	maximum troponin plasma level	48 hours post-surgery
Secondary	To assess the intraoperative safety	Existence of bradycardia requiring atropine adminitsrtation and/or appearance of arterial hypotension or hypertension	intraoperative periode