Comparison of the Postoperative Effects of Opioid-Free Anesthesia and Opioid-Based Anesthesia in Patients Undergoing Open-Heart Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- extubation time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80
- •ASA 1, 2, or 3 status
- •Will undergo open-heart surgery with cardiopulmonary bypass
排除标准
- •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
- •Patients who were intubated for more than 12 hours were excluded from the study. Patients who required IABP or ECMO during the perioperative period were excluded from the study. Patients with postoperative cerebrovascular disease and those requiring sedation in the postoperative period were also excluded from the study.
研究组 & 干预措施
opioid free anaesthesia
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
干预措施: non Opioids (Drug)
opioid anaesthesia
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
干预措施: Opioid (Drug)
结局指标
主要结局
extubation time
时间窗: postoperative 7 days
During routine patient visits, the patient's extubation time will be recorded.
mobilization
时间窗: postoperative 7 days
During routine patient visits, the patient's first mobilization time will be recorded.
first bowel movement
时间窗: postoperative 7 days
During routine patient visits, the patient's first bowel movement in the postoperative period will be recorded and documented.
vomiting
时间窗: postoperative 1 days
The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits.The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and vomiting will be assessed. If the patient has vomited, the number of times they have vomited will be asked and recorded. The total number of times the patient has vomited within 24 hours will be documented.
nausea
时间窗: postoperative 1 days
The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits. The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their nausea will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the severity of their nausea, and the response will be recorded. 0 means no nausea, and 10 means severe nausea.
Itching
时间窗: postoperative 1 days
The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits. The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and itching will be assessed.
visual analog scale
时间窗: postoperative 7 days
The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their pain will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the intensity of their pain, and the response will be recorded. 0 means no pain, and 10 means unbearable severe pain.
opening eyes first time
时间窗: postoperative 1 days
The time when the patient first opens their eyes during the ward round is noted and recorded.
Shivering
时间窗: postoperative 1 days
The patient is questioned and recorded to determine the frequency of opioid side effects during hospital visits. The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and shivering will be assessed.
additional analgesics
时间窗: postoperative 1 days
It will be assessed whether there is a need for additional analgesics within the first 24 hours. If additional analgesics are required, it will be recorded whether NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) were administered. If they were, the number of times the required and dosage of drug they were given will be noted. It will be recorded whether tramadol was administered. If it was, the number of times it was given and the required dosage in milligrams (mg) will be noted.
The Behavioral Pain Scale (BPS)
时间窗: postoperative 1 days
Intubated patients will be assessed at 0,3,6,12,24 hours; using the following criteria, and the total score will be recorded Facial expression Relaxed=1 Partially tightened (e.g., brow lowering)=2 Fully tightened (e.g., eyelid closing)=3 Grimacing=4 Upper limb movements No movement=1 Partially bent=2 Fully bent with finger flexion=3 Permanently retracted=4 Compliance with mechanical ventilation Tolerating movement=1 Coughing but tolerating ventilation for most of the time=2 Fighting ventilator=3 Unable to control ventilation=4
次要结局
- glascow coma scale(postoperative 7 days)
- critical care length of stay(postoperative 7 days)
- hospital length of stay(postoperative 7 days)
- QOR-15(postoperative 7 days)
研究者
Seda Kurtbeyoğlu
Principal Investigator
Ankara City Hospital Bilkent