Role of Opioid Free Anaesthesia in Elderly Patients Undergoing Elective Coronary Artery Bypass Graft Surgeries With Cardiopulmonary Bypass in Enhanced Recovery After Surgeries

January 14, 2026 updated by: Ain Shams University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age group: above 65 years old of both sex. Undergoing an elective coronary artery bypass graft surgeries with cardiopulmonary bypass.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Opioid free anesthesia group
Patients will receive dexmedetomidine and ketamine
Drug: Opioid free anesthesia
group (F) receive dexmedetomidine and ketamine
Active Comparator: Opioid based group
Patients will receive fentanyl
Drug: Opioid based Anesthesia
Opioid based group receive fentanyl

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enhanced recovery time
Time Frame: 24 hours
From transfer the patient to icu till extubation
24 hours
Enhanced recovery defined as time of extubation
Time Frame: 24 hours
Time from extubation after transfer to icu
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
POCD
Time Frame: 1 week
Post operative delerium by cam score which has 4 features ....to diagnose delerium patient must have 3 features
1 week
Post operative opioid consumption
Time Frame: IN the first 24 hour after surgery ...total morphine consumption
Total morphine consumption
IN the first 24 hour after surgery ...total morphine consumption
Cortisol level
Time Frame: 24 hours
cortisol level
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MD239/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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