CABGNCT07360327
Role of Opioid Free Anaesthesia in Elderly Patients Undergoing Elective Coronary Artery Bypass Graft Surgeries With Cardiopulmonary Bypass in Enhanced Recovery After Surgeries
A study testing Opioid free anesthesia and Opioid based Anesthesia in people with CABG and Dexmedetomidine, run by Ain Shams University.
Trial summary
The introduction of synthetic opioids in 1960 to general anesthesia together with sedative hypnotics and muscle relaxants allowed the appearance of the concept of multimodal balanced anesthesia. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- CABG, Dexmedetomidine, Ketamine
- What is being tested?
- Opioid free anesthesia and Opioid based Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age group: above 65 years old of both sex. Undergoing an elective coronary artery bypass graft surgeries with cardiopulmonary bypass.
Who cannot join
- Past or ongoing history of drug abuse.
- Psychiatric disease and cognitive disorders.
- Inability to perform the confusion assessment method for the intensive care unit (CAM-ICU) test.
- EF<40 %.
- 1st or 2nd degree Heart block.
- HR <50 bpm.
- Allergy from drugs used in this study.
- Use of a left ventricular assist device, IAB or ECMO pri
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The introduction of synthetic opioids in 1960 to general anesthesia together with sedative hypnotics and muscle relaxants allowed the appearance of the concept of multimodal balanced anesthesia. Although they help in achieving hemodynamic stability during anesthesia of open heart surgeries, their administration consequences are neither scarce nor benign to the patient. Perioperative opioids are associated with increased incidence of respiratory depression, prolonged mechanical ventilation, nausea and vomiting, prolonged sedation, Postoperative ileus (POI), urine retention, Postoperative cognitive dysfunction (POCD), immune depression and hyperalgesia (Beloeil et al., 2018).
Coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) is particularly vulnerable to the above-mentioned complications. Indeed, some of the side effects of this surgery overlap with the adverse effects of opioids. Postoperative pulmonary complications are observed in up to 50% of patients (Fisscher et al., 2022) and POCD or delirium in 4-54% according to studies (Bhushan et al., 2021). Whereas major gastrointestinal complications are estimated to occur in around 3% of patients, essentially acute pancreatitis, postoperative ileus (Marsoner et al., 2019).
Opioid-free anesthesia (OFA) strategies have emerged to avoid intraoperative opioid use. It is based on the fact that a sympathetic reaction evidenced by hemodynamic changes in an anesthetised patient does not systematically reflect pain. In addition, a sleeping patient will not recall pain, while hormonal stress and sympathetic and inflammatory reactions can be controlled by therapeutic classes
Read the detailed description
Study Procedures: o Randomization will allocate patients into two groups: Opioid-free (F) and Opioid-based (O) anesthesia, with numbers drawn from sealed envelopes. o Group F will receive analgesia through ketamine and dexmedetomidine based on Ideal Body Weight (IBW). o Group O will receive fentanyl for analgesia, also based on IBW. o IBW is calculated using ARDSnet formulas (Brower et al., 2000). o For men, IBW is 50 + (0.91 × [height in cm - 152.4]). o For women, IBW is 45.5 + (0.91 × [height in cm - 152.4]). o Patients will be monitored with ECG, pulse oximeter, and blood pressure monitoring before receiving midazolam for sedation. o After catheter insertion, patients will be assigned to groups based on the analgesia provided. o The analgesia will be prepared in a pharmacy, coded for blinding the anaesthetist. Fentanyl will be administered as follows: 3 mg/kg (IBW) for induction and 5 mg/kg for infusion during surgery (Baerdemaeker et al., 2004). • Ketamine and dexmedetomidine will be combined in one syringe with specific dosages for induction and infusion (Mulier et al., 2018). o Both groups will receive general anesthesia induction with midazolam, group-specific analgesia, propofol, and rocuronium before intubation. o Anesthesia maintenance will include isoflurane, group-specific analgesia infusion, and rocuronium infusions (Basagan et al., 2010).Hemodynamic parameters will be recorded at various intervals before and after induction until the patient is transferred to ICU. A 5mg bolus from the analgesia syringe will be administered for persistent tachycardia or hypertension, with a maximum of three doses before switching to second-line treatments. Norepinephrine will be given for significant hypotension. Propranolol will be administered for persistent tachycardia. Nitroglycerin will be used for persistent hypertension. Atropine will be given for severe bradycardia. Bradycardia, tachycardia, hypotension, and hypertension are defined based on specific heart rate and blood pressure changes. Propofol infusion will commence while on bypass and stop after weaning. Analgesia infusion will cease after sternum closure. Inhalational anesthetics will be discontinued at the end of the surgery, and patients will be transferred intubated and ventilated to ICU. In ICU, patients will be extubated once they meet specific requirements. Each group will be monitored for extubation timing and incidence of POCD using CAM ICU score. Cortisol levels and neutrophil lymphocytic ratio will be measured postoperatively in ICU. Patients will be excluded from the study for specific complications or delays. Post-operative analgesia will be administered regularly with paracetamol and fentanyl infusion or other analgesia in the respective groups.
- Conditions
- CABG, Dexmedetomidine, Ketamine, Opioid Free Anesthesia, Opioid Based Anesthesia
- Being tested
- Opioid free anesthesia, Opioid based Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid free anesthesiaDrug
group (F) receive dexmedetomidine and ketamine
Opioid based AnesthesiaDrug
Opioid based group receive fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Opioid free anesthesia group | Active comparator | Patients will receive dexmedetomidine and ketamine Receives: Drug: Opioid free anesthesia |
| Opioid based group | Active comparator | Patients will receive fentanyl Receives: Drug: Opioid based Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced recovery time
From transfer the patient to icu till extubation
Measured: 24 hours
Enhanced recovery defined as time of extubation
Time from extubation after transfer to icu
Measured: 24 hours
Secondary outcomes (3)
POCD
Post operative delerium by cam score which has 4 features ....to diagnose delerium patient must have 3 features
Measured: 1 week
Post operative opioid consumption
Total morphine consumption
Measured: IN the first 24 hour after surgery ...total morphine consumption
Cortisol level
cortisol level
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360327
- Sponsor's protocol ID
- FMASU MD239/2025
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Opioid Free Anaesthesia in Elderly Patients Undergoing Elective Coronary Artery Bypass Graft Surgeries With Cardiopulmonary Bypass in Enhanced Recovery After Surgeries
- ClinicalTrials.gov ID
- NCT07360327
- Acronym / sponsor ID
- FMASU MD239/2025
- Conditions
- CABG, Dexmedetomidine, Ketamine, Opioid Free Anesthesia, Opioid Based Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
The introduction of synthetic opioids in 1960 to general anesthesia together with sedative hypnotics and muscle relaxants allowed the appearance of the concept of multimodal balanced anesthesia. Although they help in achieving hemodynamic stability during anesthesia of open heart surgeries, their administration consequences are neither scarce nor benign to the patient. Perioperative opioids are associated with increased incidence of respiratory depression, prolonged mechanical ventilation, nausea and vomiting, prolonged sedation, Postoperative ileus (POI), urine retention, Postoperative cognitive dysfunction (POCD), immune depression and hyperalgesia (Beloeil et al., 2018).
Coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) is particularly vulnerable to the above-mentioned complications. Indeed, some of the side effects of this surgery overlap with the adverse effects of opioids. Postoperative pulmonary complications are observed in up to 50% of patients (Fisscher et al., 2022) and POCD or delirium in 4-54% according to studies (Bhushan et al., 2021). Whereas major gastrointestinal complications are estimated to occur in around 3% of patients, essentially acute pancreatitis, postoperative ileus (Marsoner et al., 2019).
Opioid-free anesthesia (OFA) strategies have emerged to avoid intraoperative opioid use. It is based on the fact that a sympathetic reaction evidenced by hemodynamic changes in an anesthetised patient does not systematically reflect pain. In addition, a sleeping patient will not recall pain, while hormonal stress and sympathetic and inflammatory reactions can be controlled by therapeutic classes
Detailed description
Study Procedures: o Randomization will allocate patients into two groups: Opioid-free (F) and Opioid-based (O) anesthesia, with numbers drawn from sealed envelopes. o Group F will receive analgesia through ketamine and dexmedetomidine based on Ideal Body Weight (IBW). o Group O will receive fentanyl for analgesia, also based on IBW. o IBW is calculated using ARDSnet formulas (Brower et al., 2000). o For men, IBW is 50 + (0.91 × [height in cm - 152.4]). o For women, IBW is 45.5 + (0.91 × [height in cm - 152.4]). o Patients will be monitored with ECG, pulse oximeter, and blood pressure monitoring before receiving midazolam for sedation. o After catheter insertion, patients will be assigned to groups based on the analgesia provided. o The analgesia will be prepared in a pharmacy, coded for blinding the anaesthetist. Fentanyl will be administered as follows: 3 mg/kg (IBW) for induction and 5 mg/kg for infusion during surgery (Baerdemaeker et al., 2004). • Ketamine and dexmedetomidine will be combined in one syringe with specific dosages for induction and infusion (Mulier et al., 2018). o Both groups will receive general anesthesia induction with midazolam, group-specific analgesia, propofol, and rocuronium before intubation. o Anesthesia maintenance will include isoflurane, group-specific analgesia infusion, and rocuronium infusions (Basagan et al., 2010).Hemodynamic parameters will be recorded at various intervals before and after induction until the patient is transferred to ICU. A 5mg bolus from the analgesia syringe will be administered for persistent tachycardia or hypertension, with a maximum of three doses before switching to second-line treatments. Norepinephrine will be given for significant hypotension. Propranolol will be administered for persistent tachycardia. Nitroglycerin will be used for persistent hypertension. Atropine will be given for severe bradycardia. Bradycardia, tachycardia, hypotension, and hypertension are defined based on specific heart rate and blood pressure changes. Propofol infusion will commence while on bypass and stop after weaning. Analgesia infusion will cease after sternum closure. Inhalational anesthetics will be discontinued at the end of the surgery, and patients will be transferred intubated and ventilated to ICU. In ICU, patients will be extubated once they meet specific requirements. Each group will be monitored for extubation timing and incidence of POCD using CAM ICU score. Cortisol levels and neutrophil lymphocytic ratio will be measured postoperatively in ICU. Patients will be excluded from the study for specific complications or delays. Post-operative analgesia will be administered regularly with paracetamol and fentanyl infusion or other analgesia in the respective groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid free anesthesia group | Active comparator | Drug: Opioid free anesthesiaPatients will receive dexmedetomidine and ketamine |
| Opioid based group | Active comparator | Drug: Opioid based AnesthesiaPatients will receive fentanyl |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age group: above 65 years old of both sex. Undergoing an elective coronary artery bypass graft surgeries with cardiopulmonary bypass.
Key exclusion criteria (8 listed)
- Past or ongoing history of drug abuse.
- Psychiatric disease and cognitive disorders.
- Inability to perform the confusion assessment method for the intensive care unit (CAM-ICU) test.
- EF<40 %.
- 1st or 2nd degree Heart block.
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 |
|---|---|---|
| Opioid free anesthesiagroup (F) receive dexmedetomidine and ketamine | Drug | Opioid free anesthesia group |
| Opioid based AnesthesiaOpioid based group receive fentanyl | Drug | Opioid based group |
Primary outcome
Enhanced recovery time
Time frame: 24 hours
From transfer the patient to icu till extubation
Enhanced recovery defined as time of extubation
Time frame: 24 hours
Time from extubation after transfer to icu
3 secondary outcomes
POCD
Time frame: 1 week
Post operative opioid consumption
Time frame: IN the first 24 hour after surgery ...total morphine consumption
Cortisol level
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for CABG
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
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.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid free anesthesia and Opioid based Anesthesia in people with CABG and Dexmedetomidine, run by Ain Shams University.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Mohamed Abdelrhman mohamed, Assistant lecturer (01024242615, Mahmoudbdel@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced recovery time (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.