Opioid-free Anesthesia and Quality of Recovery After General Anesthesia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSelcuk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Geriatric patients over 65 years old undergoing major surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Opioid-Based Anesthesia (Group 1)
Group B: Opioid-Free Anesthesia (Group 2)
Trial outcomes
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.
Time frame
The quality of recovery will be assessed using the QoR-15 scale at 24, 48, and 72 hours postoperatively.Secondary outcomes
1
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.
Time frame
Postoperative cognitive dysfunction will be evaluated using the MMSE, administered preoperatively and at 24 hours postoperatively.2
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.
Time frame
Postoperative cognitive dysfunction will be evaluated using the Clock Drawing Test, administered preoperatively and at 24 hours postoperatively.3
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).
Time frame
Postoperative pain will be assessed using the Visual Analog Scale (VAS) at PACU, and at 6, 12, 24, and 48 hours postoperatively.4
Opioid consumption
Opioid consumption will be evaluated using Contramal via a patient-controlled analgesia (PCA) device.
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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