Opioid-free Anesthesia and Quality of Recovery After General Anesthesia

NCT06846333 | Not Yet Recruiting

• 1 other identifier: 2025/2
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid-free Anesthesia; Geriatric Population

Outcome Measures

Primary Outcomes (1)

• 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.

  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 MMSE, administered preoperatively and at 24 hours postoperatively.

• Postoperative cognitive dysfunction

  Postoperative cognitive dysfunction will be evaluated using the Clock Drawing Test, administered preoperatively and at 24 hours postoperatively.

• Postoperative pain management

  Postoperative pain will be assessed using the Visual Analog Scale (VAS) at PACU, and at 6, 12, 24, and 48 hours postoperatively.

• Opioid consumption

  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 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Geriatric patients over 65 years old undergoing major surgery

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Selcuk University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 26, 2025
• Study Start: February 20, 2025
• Primary Completion: April 25, 2025
• Study Completion: April 30, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02