An observational study in Undergoing Open-Heart Surgery, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Ankara City Hospital Bilkent · Observational
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.
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.
Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 18 to 80 with 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:
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.
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
Drug: non Opioids
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
Drug: Opioid
It is planned to avoid opioid side effects by applying opioid-free anesthesia during the perioperative period.
Also known as: opioid anaesthesia
Routine general anesthesia in cardiac surgery
extubation time
During routine patient visits, the patient's extubation time will be recorded.
Time frame: postoperative 7 days
mobilization
During routine patient visits, the patient's first mobilization time will be recorded.
Time frame: postoperative 7 days
first bowel movement
During routine patient visits, the patient's first bowel movement in the postoperative period will be recorded and documented.
Time frame: postoperative 7 days
vomiting
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.
Time frame: postoperative 1 days
nausea
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.
Time frame: postoperative 1 days
Itching
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.
Time frame: postoperative 1 days
visual analog scale
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.
Time frame: postoperative 7 days
opening eyes first time
The time when the patient first opens their eyes during the ward round is noted and recorded.
Time frame: postoperative 1 days
Shivering
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.
Time frame: postoperative 1 days
additional analgesics
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.
Time frame: postoperative 1 days
The Behavioral Pain Scale (BPS)
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
Time frame: postoperative 1 days
glascow coma scale
0,3,6,12 and 24.hour glascow coma scale will be recorded. 1. Eye Opening (E): * 4: Spontaneous * 3: To speech * 2: To pain * 1: No response 2. Verbal Response (V): * 5: Oriented * 4: Confused conversation * 3: Inappropriate words * 2: Incomprehensible sounds * 1: No response 3. Motor Response (M): * 6: Obeys commands * 5: Localizes pain * 4: Withdrawal * 3: Flexion to pain (decorticate posture) * 2: Extension to pain (decerebrate posture) * 1: No response Total Score: * The scores from each of the three categories are added together.
Time frame: postoperative 7 days
critical care length of stay
critical care length of stay will be recorded.
Time frame: postoperative 7 days
hospital length of stay
The hospital length of stay will be recorded.
Time frame: postoperative 7 days
QOR-15
The QOR-15 index was used to assess patient satisfaction. A questionnaire containing 15 questions related to patient recovery is administered to patients 24 hours after extubation. For each question, patients are asked to rate their answers on a scale from 0 to 10. The total score is recorded. 0 = Never 10 = Always
Time frame: postoperative 7 days
Plan to share: No
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ankara City Hospital Bilkent