Undergoing Open-Heart SurgeryOpioid-FreeNCT06683911
Opioids Continue to Play a Primary Role in the Management of Perioperative Pain Due to Opioid-Free Anesthesia in Open Heart Surgery.
An observational study of Undergoing Open-Heart Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Undergoing Open-Heart Surgery
- What is being tested?
- non Opioids and Opioid
- Type of treatment
- Injection or infusion
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2024to 3 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged 18 to 80
- ASA 1, 2, or 3 status
- Will undergo open-heart surgery with cardiopulmonary bypass
Who cannot join
- 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%
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Cankaya, 06800
About this study
Official title: Comparison of the Postoperative Effects of Opioid-Free Anesthesia and Opioid-Based Anesthesia in Patients Undergoing Open-Heart Surgery With Cardiopulmonary Bypass
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.
Read the 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
- Being tested
- non Opioids, Opioid
- Keywords
- Open-Heart Surgery, opioid free anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non OpioidsDrug
Also called opioid anaesthesia
It is planned to avoid opioid side effects by applying opioid-free anesthesia during the perioperative period.
OpioidDrug
Routine general anesthesia in cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: non Opioids | |
| 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 Receives: Drug: Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation time
During routine patient visits, the patient's extubation time will be recorded.
Measured: postoperative 7 days
mobilization
During routine patient visits, the patient's first mobilization time will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: postoperative 7 days
opening eyes first time
The time when the patient first opens their eyes during the ward round is noted and recorded.
Measured: 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.
Measured: 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.
Measured: 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
Measured: postoperative 1 days
Secondary outcomes (4)
glascow coma scale
0,3,6,12 and 24.hour glascow coma scale will be recorded.
- Eye Opening (E):
- 4: Spontaneous
- 3: To speech
- 2: To pain
- 1: No response
- Verbal Response (V):
- 5: Oriented
- 4: Confused conversation
- 3: Inappropriate words
- 2: Incomprehensible sounds
- 1: No response
- 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.
Measured: postoperative 7 days
critical care length of stay
critical care length of stay will be recorded.
Measured: postoperative 7 days
hospital length of stay
The hospital length of stay will be recorded.
Measured: 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
Measured: postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start3 Apr 2024
- Primary completion3 Apr 2024
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Undergoing Open-Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Kurtbeyoğlu, Ankara City Hospital Bilkent
- Investigators
- Seda Kurtbeyoglu, doctor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683911
- Sponsor's protocol ID
- Opioid-Free Anesthesia
- Acronym
- Opioid-Free
- Status last verified
- May 2025
- First submitted
- 9 Nov 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716.
PubMed 31045633Chanowski EJP, Horn JL, Boyd JH, Tsui BCH, Brodt JL. Opioid-Free Ultra-Fast-Track On-Pump Coronary Artery Bypass Grafting Using Erector Spinae Plane Catheters. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1988-1990. doi: 10.1053/j.jvca.2018.10.012. Epub 2018 Oct 13. No abstract available.
PubMed 30424939
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Effects of Opioid-Free Anesthesia and Opioid-Based Anesthesia in Patients Undergoing Open-Heart Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06683911
- Acronym / sponsor ID
- Opioid-Free / Opioid-Free Anesthesia
- Conditions
- Undergoing Open-Heart Surgery
- Keywords
- Open-Heart Surgery, opioid free anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid free anaesthesia | – | Drug: non Opioidsİnduction = 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 |
| opioid anaesthesia | – | Drug: Opioidİnduction = 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Aged 18 to 80
- ASA 1, 2, or 3 status
- Will undergo open-heart surgery with cardiopulmonary bypass
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non OpioidsAlso: opioid anaesthesiaIt is planned to avoid opioid side effects by applying opioid-free anesthesia during the perioperative period. | Drug | opioid free anaesthesia |
| OpioidRoutine general anesthesia in cardiac surgery | Drug | opioid anaesthesia |
Primary outcome
extubation time
Time frame: postoperative 7 days
During routine patient visits, the patient's extubation time will be recorded.
mobilization
Time frame: postoperative 7 days
During routine patient visits, the patient's first mobilization time will be recorded.
first bowel movement
Time frame: postoperative 7 days
During routine patient visits, the patient's first bowel movement in the postoperative period will be recorded and documented.
vomiting
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: postoperative 1 days
The time when the patient first opens their eyes during the ward round is noted and recorded.
Shivering
Time frame: 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
Time frame: 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)
Time frame: 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
4 secondary outcomes
glascow coma scale
Time frame: postoperative 7 days
critical care length of stay
Time frame: postoperative 7 days
hospital length of stay
Time frame: postoperative 7 days
QOR-15
Time frame: postoperative 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Results publication: PubMed 31045633Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716.
- Results publication: PubMed 30424939Chanowski EJP, Horn JL, Boyd JH, Tsui BCH, Brodt JL. Opioid-Free Ultra-Fast-Track On-Pump Coronary Artery Bypass Grafting Using Erector Spinae Plane Catheters. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1988-1990. doi: 10.1053/j.jvca.2018.10.012. Epub 2018 Oct 13. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Kurtbeyoglu, doctor principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undergoing Open-Heart Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
extubation time (time frame: postoperative 7 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.