NCT06683911

Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Opioid-Free Anesthesia in Open Heart Surgery.

Comparison of the Postoperative Effects of Opioid-Free Anesthesia and Opioid-Based Anesthesia in Patients Undergoing Open-Heart Surgery With Cardiopulmonary Bypass

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Undergoing Open-Heart Surgery

Interventions

Type	Name	Description
DRUG	non Opioids	It is planned to avoid opioid side effects by applying opioid-free anesthesia during the perioperative period.
DRUG	Opioid	Routine general anesthesia in cardiac surgery

Timeline

• Start date: 2024-04-03
• Primary completion: 2024-04-03
• Completion: 2025-04-03
• First posted: 2024-11-12
• Last updated: 2025-05-06

Locations

1 site across 1 country: Turkey (Türkiye)