Opioid-free Anesthesia and Quality of Recovery After General Anesthesia

NCT ID: NCT06846333

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2025-04-30

Brief 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. 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:

1. Opioid-Based Anesthesia (Group 1): Induction with propofol, fentanyl, and rocuronium; maintenance with remifentanil and sevoflurane.

2. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Meltem Mavuş

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025/2

Identifier Type: -

Identifier Source: org_study_id