Opioid-free AnesthesiaNCT06846333
Opioid-free Anesthesia and Quality of Recovery After General Anesthesia
An observational study of Opioid-free Anesthesia and Geriatric Population, run by Selcuk University.
Trial summary
This study aimed to evaluate the effect of an opioid-free anesthesia protocol on postoperative recovery quality in patients aged 65 years and older undergoing major surgery. Recovery quality was assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Opioid-free Anesthesia, Geriatric Population
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2025to 30 Apr 2025
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric patients over 65 years old undergoing major surgery
Who may be able to join
- Patients aged 65 and older
- Undergoing major elective non-cardiac surgery under general anesthesia
- Classified as ASA I-II-III
- With sufficient cognitive ability to complete a questionnaire were included in the study
Who cannot join
- Patients requiring rapid sequence induction for emergency cases
- Those with severe psychiatric or cognitive disorders preventing questionnaire evaluation
- A body mass index < 18 or > 39 kg/m²
- Allergy or contraindication to any drug included in the study
- A history of chronic pain or chronic opioid use
- Uncontrolled epilepsy, decompensated heart failure
Show all 11Show fewer
- Chronic kidney or liver failure
- Preoperative bradycardia with atrioventricular block (2nd or 3rd degree)
- Heart rate < 50 bpm due to chronic beta-blocker therapy
- Those using medications that prolong the QT interval
- Patients whose anesthesia regimen was intraoperatively changed (from opioid-free to opioid-containing anesthesia)
About this study
Official title: Effect of Opioid-free Anesthesia Protocol on Quality of Recovery After Major Surgery in Geriatric Patients
This study aimed to evaluate the effect of an opioid-free anesthesia protocol on postoperative recovery quality in patients aged 65 years and older undergoing major surgery. Recovery quality was assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Findings are expected to contribute to optimizing anesthesia practices in the elderly population by improving recovery quality and reducing opioid-related side effects.
Read the detailed description
This prospective observational study aims to evaluate the impact of an opioid-free anesthesia (OFA) protocol on postoperative recovery quality in geriatric patients aged 65 years and older undergoing major non-cardiac surgery. Recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24, 48, and 72 hours postoperatively. Secondary outcomes include postoperative pain intensity (measured via VAS), opioid consumption (measured through patient-controlled analgesia devices), the incidence of postoperative cognitive dysfunction (POCD) assessed using the Mini-Mental Test (MMT) and the Clock Drawing Test, and the frequency of opioid-related adverse events (nausea, vomiting, constipation, urinary retention, dizziness, and others). Furthermore, intraoperative hemodynamic stability, extubation time, time to spontaneous ventilation recovery, and lengths of stay in the post-anesthesia care unit (PACU) and the hospital will also be recorded.
The rationale for this study is rooted in the significant side effects of opioids, such as postoperative nausea and vomiting (PONV), hyperalgesia, sedation, and respiratory depression, which can prolong recovery time and hospital discharge. To accelerate postoperative recovery and minimize opioid-related side effects, "Enhanced Recovery After Surgery (ERAS)" protocols, which have gained popularity in recent years, include OFA as an alternative analgesic strategy. OFA protocols provide multimodal analgesia through non-opioid drugs and techniques targeting various pain pathways, potentially reducing the incidence of chronic pain and expediting recovery.
A key component of the OFA protocol used in this study is ketamine, which has shown efficacy in reducing neuroinflammation and improving cognitive function, making it particularly relevant in the elderly population at risk of postoperative cognitive dysfunction. While evidence supporting the benefits of OFA in various surgical fields such as gynecology, orthopedics, and gastrointestinal surgeries is growing, there remains a lack of data on its effects on recovery outcomes in geriatric patients undergoing major surgeries. This study aims to address this gap by providing comprehensive data on the impact of OFA on recovery quality, opioid-related adverse events, and perioperative outcomes in this vulnerable population.
Patients will be divided into two groups based on the anesthesiologist's clinical preference:
- Opioid-Based Anesthesia (Group 1): Induction with propofol, fentanyl, and rocuronium; maintenance with remifentanil and sevoflurane.
- Opioid-Free Anesthesia (Group 2): Induction with propofol, ketamine, and rocuronium; maintenance with ketamine and propofol infusions, along with sevoflurane.
Both groups will undergo standard perioperative monitoring, including BIS (bispectral index) for anesthesia depth and continuous hemodynamic monitoring. Recovery parameters such as extubation time, spontaneous ventilation recovery, and PACU length of stay will be recorded in detail. Postoperatively, the QoR-15 questionnaire will be completed at 24, 48, and 72 hours, with follow-up by telephone for patients discharged early.
This study is expected to contribute to the limited literature on the application of OFA in geriatric surgical patients. By highlighting the potential benefits of OFA in enhancing postoperative recovery, reducing opioid consumption, and preventing opioid-related adverse events, this research aims to provide insights for safer and more effective anesthesia practices in the elderly population.
- Conditions
- Opioid-free Anesthesia, Geriatric Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Based Anesthesia (Group 1) | Group I patients underwent induction with propofol (2.0 mg/kg), fentanyl (2 µg/kg), and rocuronium (0.6 mg/kg). Maintenance of anesthesia was achieved using remifentanil (0.1-0.25 µg/kg/min), titrated to maintain a BIS level of 40-60, and the inhalation anesthetic agent sevoflurane, targeting a MAC of 1.0-1.5. No external intervention was made regarding drug dosages | |
| Opioid-Free Anesthesia (Group 2) | Group II patients underwent induction with propofol (2.0 mg/kg), ketamine (0.3 mg/kg), and rocuronium (0.6 mg/kg). Maintenance of anesthesia was achieved using ketamine (10-45 µg/kg/min), titrated to maintain a BIS level of 40-60, and sevoflurane, targeting a MAC of 1.0-1.5. In Group II, the ketamine infusion was discontinued 30 minutes before the end of the surgery. No external intervention was made regarding drug dosages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
The quality of recovery will be evaluated using the quality of recovery 15 (QoR-15) scale.QoR-15 is a 15-item questionnaire that assesses the patient's emotional state, physical comfort, psychological support, physical independence, and pain status, with each question scored between 0 (never) and 10 (always); a total score of less than 90 is considered poor, a score between 90 and 121 is moderate, a score between 122 and 135 is good, and a score above 135 indicates excellent recovery.
Measured: The quality of recovery will be assessed using the QoR-15 scale at 24, 48, and 72 hours postoperatively.
Secondary outcomes (10)
Postoperative cognitive dysfunction
Postoperative cognitive dysfunction will be evaluated using the Mini Mental State Examination (MMSE). The MMSE score is considered to indicate normal cognitive function if it ranges between 30 and 24, mild cognitive impairment if it is between 23 and 20, moderate cognitive impairment if it falls between 19 and 10, and severe cognitive impairment if it is 9 or below.
Measured: Postoperative cognitive dysfunction will be evaluated using the MMSE, administered preoperatively and at 24 hours postoperatively.
Postoperative cognitive dysfunction
Postoperative cognitive dysfunction will be evaluated using the Clock Drawing Test. According to the Clock Drawing Test, a score between 8 and 10 indicates normal cognitive function, a score between 5 and 7 suggests mild cognitive impairment, and a score of 4 or below signifies moderate to severe cognitive impairment.
Measured: Postoperative cognitive dysfunction will be evaluated using the Clock Drawing Test, administered preoperatively and at 24 hours postoperatively.
Postoperative pain management
Postoperative pain assessment will be evaluated using the Visual Analog Scale (VAS). VAS is a subjective and visual assessment method where the patient rates pain intensity on a scale from 0 (no pain) to 10 (worst pain).
Measured: Postoperative pain will be assessed using the Visual Analog Scale (VAS) at PACU, and at 6, 12, 24, and 48 hours postoperatively.
Opioid consumption
Opioid consumption will be evaluated using Contramal via a patient-controlled analgesia (PCA) device.
Measured: The total drug consumption and the amounts administered via the PCA device at postoperative 6, 12, 24, and 48 hours will be recorded.
To evaluate recovery profile
The time elapsed until spontaneous ventilation (the period between the cessation of anesthesia and the initiation of spontaneous ventilation) was recorded in seconds.
Measured: The time to spontaneous ventilation, defined as the time between the cessation of anesthesia and the initiation of spontaneous ventilation, was recorded in seconds during the perioperative period.
To evaluate recovery profile
Time to extubation time (the time between anesthetic discontinuation and extubation) was recorded in seconds.
Measured: The extubation time, defined as the time from the cessation of anesthesia to extubation, was recorded in seconds during the perioperative period.
To evaluate recovery profile
The eye-opening time during the perioperative period (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching) was recorded in seconds.
Measured: The eye-opening time, defined as the time between the cessation of anesthesia and eye opening in response to verbal or painful stimuli, was recorded in seconds during the perioperative period.
To evaluate recovery profile
The PACU discharge time (the time from arrival at the PACU to transfer to the ward) was recorded in minutes.
Measured: The time to discharge from the PACU was recorded in minutes, defined as the time from arrival at the PACU to transfer to the ward during the perioperative period.
To evaluate recovery profile
The length of hospital stay (calculated by subtracting the admission date from the discharge date) was recorded in days.
Measured: The length of hospital stay was recorded in days during the perioperative period, calculated by subtracting the admission date from the discharge date
Opioid-Related Adverse Events
Opioid-related adverse events (nausea, vomiting, constipation, difficulty urinating, difficulty concentrating, drowsiness or difficulty staying awake, dizziness, feeling sleepy, general fatigue or weakness, itching, dry mouth, and headache).
Measured: Opioid-related adverse events observed within 72 hours after surgery were recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-free AnesthesiaStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Mavuş, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846333
- Sponsor's protocol ID
- 2025/2
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioid-free Anesthesia Protocol on Quality of Recovery After Major Surgery in Geriatric Patients
- ClinicalTrials.gov ID
- NCT06846333
- Acronym / sponsor ID
- 2025/2
- Conditions
- Opioid-free Anesthesia, Geriatric Population
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Feb 2025 (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.
This study aimed to evaluate the effect of an opioid-free anesthesia protocol on postoperative recovery quality in patients aged 65 years and older undergoing major surgery. Recovery quality was assessed using the Quality of Recovery-15 (QoR-15) questionnaire. Findings are expected to contribute to optimizing anesthesia practices in the elderly population by improving recovery quality and reducing opioid-related side effects.
Detailed description
This prospective observational study aims to evaluate the impact of an opioid-free anesthesia (OFA) protocol on postoperative recovery quality in geriatric patients aged 65 years and older undergoing major non-cardiac surgery. Recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24, 48, and 72 hours postoperatively. Secondary outcomes include postoperative pain intensity (measured via VAS), opioid consumption (measured through patient-controlled analgesia devices), the incidence of postoperative cognitive dysfunction (POCD) assessed using the Mini-Mental Test (MMT) and the Clock Drawing Test, and the frequency of opioid-related adverse events (nausea, vomiting, constipation, urinary retention, dizziness, and others). Furthermore, intraoperative hemodynamic stability, extubation time, time to spontaneous ventilation recovery, and lengths of stay in the post-anesthesia care unit (PACU) and the hospital will also be recorded.
The rationale for this study is rooted in the significant side effects of opioids, such as postoperative nausea and vomiting (PONV), hyperalgesia, sedation, and respiratory depression, which can prolong recovery time and hospital discharge. To accelerate postoperative recovery and minimize opioid-related side effects, "Enhanced Recovery After Surgery (ERAS)" protocols, which have gained popularity in recent years, include OFA as an alternative analgesic strategy. OFA protocols provide multimodal analgesia through non-opioid drugs and techniques targeting various pain pathways, potentially reducing the incidence of chronic pain and expediting recovery.
A key component of the OFA protocol used in this study is ketamine, which has shown efficacy in reducing neuroinflammation and improving cognitive function, making it particularly relevant in the elderly population at risk of postoperative cognitive dysfunction. While evidence supporting the benefits of OFA in various surgical fields such as gynecology, orthopedics, and gastrointestinal surgeries is growing, there remains a lack of data on its effects on recovery outcomes in geriatric patients undergoing major surgeries. This study aims to address this gap by providing comprehensive data on the impact of OFA on recovery quality, opioid-related adverse events, and perioperative outcomes in this vulnerable population.
Patients will be divided into two groups based on the anesthesiologist's clinical preference:
- Opioid-Based Anesthesia (Group 1): Induction with propofol, fentanyl, and rocuronium; maintenance with remifentanil and sevoflurane.
- Opioid-Free Anesthesia (Group 2): Induction with propofol, ketamine, and rocuronium; maintenance with ketamine and propofol infusions, along with sevoflurane.
Both groups will undergo standard perioperative monitoring, including BIS (bispectral index) for anesthesia depth and continuous hemodynamic monitoring. Recovery parameters such as extubation time, spontaneous ventilation recovery, and PACU length of stay will be recorded in detail. Postoperatively, the QoR-15 questionnaire will be completed at 24, 48, and 72 hours, with follow-up by telephone for patients discharged early.
This study is expected to contribute to the limited literature on the application of OFA in geriatric surgical patients. By highlighting the potential benefits of OFA in enhancing postoperative recovery, reducing opioid consumption, and preventing opioid-related adverse events, this research aims to provide insights for safer and more effective anesthesia practices in the elderly population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Based Anesthesia (Group 1) | – | –Group I patients underwent induction with propofol (2.0 mg/kg), fentanyl (2 µg/kg), and rocuronium (0.6 mg/kg). Maintenance of anesthesia was achieved using remifentanil (0.1-0.25 µg/kg/min), titrated to maintain a BIS level of 40-60, and the inhalation anesthetic agent sevoflurane, targeting a MAC of 1.0-1.5. No external intervention was made regarding drug dosages |
| Opioid-Free Anesthesia (Group 2) | – | –Group II patients underwent induction with propofol (2.0 mg/kg), ketamine (0.3 mg/kg), and rocuronium (0.6 mg/kg). Maintenance of anesthesia was achieved using ketamine (10-45 µg/kg/min), titrated to maintain a BIS level of 40-60, and sevoflurane, targeting a MAC of 1.0-1.5. In Group II, the ketamine infusion was discontinued 30 minutes before the end of the surgery. No external intervention was made regarding drug dosages. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric patients over 65 years old undergoing major surgery
Key inclusion criteria (4 listed)
- Patients aged 65 and older
- Undergoing major elective non-cardiac surgery under general anesthesia
- Classified as ASA I-II-III
- With sufficient cognitive ability to complete a questionnaire were included in the study
Key exclusion criteria (11 listed)
- Patients requiring rapid sequence induction for emergency cases
- Those with severe psychiatric or cognitive disorders preventing questionnaire evaluation
- A body mass index < 18 or > 39 kg/m²
- Allergy or contraindication to any drug included in the study
- A history of chronic pain or chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Recovery
Time frame: The quality of recovery will be assessed using the QoR-15 scale at 24, 48, and 72 hours postoperatively.
The quality of recovery will be evaluated using the quality of recovery 15 (QoR-15) scale.QoR-15 is a 15-item questionnaire that assesses the patient's emotional state, physical comfort, psychological support, physical independence, and pain status, with each question scored between 0 (never) and 10 (always); a total score of less than 90 is considered poor, a score between 90 and 121 is moderate, a score between 122 and 135 is good, and a score above 135 indicates excellent recovery.
10 secondary outcomes
Postoperative cognitive dysfunction
Time frame: Postoperative cognitive dysfunction will be evaluated using the MMSE, administered preoperatively and at 24 hours postoperatively.
Postoperative cognitive dysfunction
Time frame: Postoperative cognitive dysfunction will be evaluated using the Clock Drawing Test, administered preoperatively and at 24 hours postoperatively.
Postoperative pain management
Time frame: Postoperative pain will be assessed using the Visual Analog Scale (VAS) at PACU, and at 6, 12, 24, and 48 hours postoperatively.
Opioid consumption
Time frame: The total drug consumption and the amounts administered via the PCA device at postoperative 6, 12, 24, and 48 hours will be recorded.
To evaluate recovery profile
Time frame: The time to spontaneous ventilation, defined as the time between the cessation of anesthesia and the initiation of spontaneous ventilation, was recorded in seconds during the perioperative period.
To evaluate recovery profile
Time frame: The extubation time, defined as the time from the cessation of anesthesia to extubation, was recorded in seconds during the perioperative period.
To evaluate recovery profile
Time frame: The eye-opening time, defined as the time between the cessation of anesthesia and eye opening in response to verbal or painful stimuli, was recorded in seconds during the perioperative period.
To evaluate recovery profile
Time frame: The time to discharge from the PACU was recorded in minutes, defined as the time from arrival at the PACU to transfer to the ward during the perioperative period.
To evaluate recovery profile
Time frame: The length of hospital stay was recorded in days during the perioperative period, calculated by subtracting the admission date from the discharge date
Opioid-Related Adverse Events
Time frame: Opioid-related adverse events observed within 72 hours after surgery were recorded.
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 26 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-free Anesthesia and Geriatric Population, run by Selcuk 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 4 inclusion and 11 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 26 Feb 2025. 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?
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?
Quality of Recovery (time frame: The quality of recovery will be assessed using the QoR-15 scale at 24, 48, and 72 hours postoperatively.). 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 26 Feb 2025.