Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Their Superior Efficacy in Analgesia, Due to Adverse Effects. we Aimed to Compare the Effects of Opioid-based Anesthesia and Opioid-free Anesthesia on Postoperative Recovery After Open Heart Surgery. (Opioid-Free)

Ankara City Hospital

Status: Active, not recruiting

Conditions: Undergoing Open-Heart Surgery With Cardiopulmonary Bypass

Treatments: Drug: non Opioids; Drug: Opioid

Study type: Observational

Funder types: Other

Identifiers

NCT06683911

Opioid-Free Anesthesia

Details and patient eligibility

About

Due to their superior efficacy in analgesia, opioids continue to play a primary role in the control of intraoperative and postoperative pain. Fentanyl, remifentanil, morphine, and tramadol are commonly used opioids during the perioperative period in cardiac surgery. However, the use of opioids requires monitoring, caution, and expertise due to their adverse effects, such as myocardial depression, prolonged respiratory depression, constipation, nausea and vomiting, itching, and dependence. To avoid the side effects caused by opioids, new opioid-free anesthesia protocols have been developed. In addition to avoiding unwanted opioid-related side effects, opioid-free anesthesia provides other benefits, such as rapid postoperative recovery, improvement in postoperative pain scores, enhancement in inflammation parameters, and reduction in postoperative delirium. In opioid-free anesthesia protocols, medications such as dexmedetomidine, magnesium sulfate, lidocaine, ketamine, gabapentin (preoperative and postoperative), dexamethasone, acetaminophen, esmolol, and urapidil are used alongside regional anesthesia techniques to control pain and sympathetic activity.

In this study, patients undergoing elective cardiopulmonary bypass surgery will be included. Procedures will be conducted according to our clinic's routine protocol with monitored general anesthesia induction. Patients included in the study will receive regional blocks and local infiltration anesthesia, which are routine in our clinic. The anesthesia teams, working with the same surgical team in our clinic, will administer either opioid-free anesthesia or anesthesia with opioids. During the perioperative period, the clinicians involved in the study will only observe the patients and record data without intervening in the anesthesia practices.

In this study, our primary aim is to compare the effects of opioid anesthesia and opioid-free anesthesia on postoperative recovery in patients who are provided with multimodal analgesic control through fascial plane blocks and continuous local infiltration anesthesia during the perioperative period. Our secondary objectives are to investigate the effects of opioid-free anesthesia on intensive care and hospital stays, postoperative delirium, inflammation parameters, postoperative surgical complications, arrhythmia, total drug doses used, cost, and patient satisfaction.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients aged 18 to 80 ASA 1, 2, or 3 status who undergo open-heart surgery with cardiopulmonary bypass and consent to participate in the study by signing the informed consent form.

Exclusion criteria

Under 18 years of age Over 80 years of age Patients with signs of severe organ failure (e.g., kidney or liver failure) ASA classification of 4 or higher BMI > 40 Left ventricular ejection fraction < 25% Patients with severe arrhythmia Patients with severe valve disease Aortic surgery Preoperative intubation Preoperative life support dependency Limited preoperative cooperation Failed block attempts Allergy to any drugs used in the study Patients with severe neurological dysfunction Patients with contraindications for blocks

Trial design

96 participants in 2 patient groups

opioid free anaesthesia

Description:

İnduction = 1 mg/kg lidocaine, 2-3 mg/kg propofol, 15 mg/kg magnesium, 1 mcg/kg dexmedetomidine (over 10 minutes), and a 0.6 mg/kg rocuronium.1 g acetaminophen, 4 mg ondansetron. Blocks will include bilateral transverse thoracic muscle plane block and/or bilateral serratus anterior plane block with 0.5% bupivacaine (max 2 mg/kg) under ultrasound guidance. Intravenous dexmedetomidine (0.1-1.4 mcg/kg/hr), lidocaine (0.5-1 mg/kg/hr), magnesium (1-10 mg/kg/hr), and propofol (1.5-12 mg/kg/hr) infusions will be adjusted based on hemodynamic parameters to achieve a target BIS value of 40-60. if: heart rate \<80 and blood pressure \>140/90 mmHg, urapidil heart rate \>80 and blood pressure \>140/90 mmHg, esmolol heart rate \<50, atropine mean arterial pressure \<60 mmHg, ephedrine will be administered. Local infiltration anesthesia will be administered through a catheter placed at the end of surgery, using bupivacaine at a concentration=2mg/ml and dosage=1.5 mg/kg/24 hours

Treatment:

Drug: non Opioids

opioid anaesthesia

Description:

İnduction = 1 mcg/kg remifentanil and/or 1-5 mg fentanyl, 2-3 mg/kg propofol, intravenous 1 mg/kg lidocaine, 2-3 mg/kg propofol, and a 0.6 mg/kg rocuronium.1 g acetaminophen, 4 mg ondansetron. Blocks will include bilateral transverse thoracic muscle plane block and/or bilateral serratus anterior plane block with 0.5% bupivacaine (max 2 mg/kg) under ultrasound guidance. Intravenous remifentanil (0.02-2 mcg/kg/hr) and propofol (1.5-12 mg/kg/hr) infusions will be adjusted based on hemodynamic parameters to achieve a target BIS value of 40-60. if: heart rate \<80 and blood pressure \>140/90 mmHg, urapidil heart rate \>80 and blood pressure \>140/90 mmHg, esmolol heart rate \<50, atropine mean arterial pressure \<60 mmHg, ephedrine will be administered. Local infiltration anesthesia will be administered through a catheter placed at the end of surgery, using bupivacaine at a concentration=2mg/ml and dosage=1.5 mg/kg/24 hours

Treatment:

Drug: Opioid