The goal of this clinical trial is to learn if an anesthesia management strategy called opioid-sparing anesthesia could help reduce postoperative opioid consumption, pain intensity and enhance recovery in elderly patients undergoing spine surgery. The main questions it aims to answer are: Does opioid-sparing anesthesia reduce postoperative opioid consumption? Dose opioid-sparing anesthesia improve postoperative pain and enhance recovery? Researchers will compare opioid-sparing anesthesia to routine anesthesia which is used most common in clinical practice to see if opioid-sparing anesthesia lead to fewer postoperative opioid consumption and better pain and recovery outcomes. Participants will randomly assigned to one of two groups. One group will receive opioid-sparing anesthesia management , while the other group will receive routine anesthesia management during general anesthesia. Participants will provide two rectal swab samples for analysis, complete five questionnaires once preoperatively, and then complete five questionnaires daily for three days postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The opioid-sparing anesthesia protocol consists of continuous intravenous infusion of ketamine (5 μg/kg/min) and dexmedetomidine (0.6 μg/kg/h) during general anesthesia. If needed during surgery, rescue analgesia with dexmedetomidine (0.4 μg/kg, i.v.) or ketamine (5 mg, i.v.) may be administered as clinically indicated.
Routine anesthesia consisting of standard general anesthetic management per institutional practice, which include opioid-based analgesia as clinically indicated, which is fentanyl 100 μg during induction, and if needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.
Opioid consumption
Total morphine equivalent consumption during the first 24 hours after surgery
Time frame: From end of surgery to 24 hours after surgery
Pain Scores (NRS)
Pain intensity will be assessed after recovery and 1, 6, 24, 48, 72 hours after surgery using the Numeric Rating Scale (NRS) daily, including NRS at rest, NRS on movement.
Time frame: From end of surgery to postoperative 72 hours
Time to First Rescue Analgesia
The exact time (in hours and minutes) from the end of surgery to the administration of the first rescue analgesic will be recorded.
Time frame: From end of surgery to the administration of the first rescue analgesic
Total Analgesic Consumption
The cumulative amount of all pain medications (opioid and non-opioid, oral and intravenous) administered within 3 days postoperatively, including total morphine equivalent consumption during 48 hours and 72 hours after surgery.
Time frame: From end of surgery to postoperative 72 hours
Time to first postoperative flatus
The exact time (in hours and minutes) from the end of surgery to the first postoperative flatus will be recorded.
Time frame: Up to 72 hours postoperatively
Quality of recovery
The quality of recovery after surgery will be evaluated using Quality of Recovery-15 (QoR-15) at 1 day after surgery.
Time frame: At 1 day after surgery
Sleep quality
The sleep quality after surgery will be evaluated daily for the first 3 postoperative days using Richards-Campbell Sleep Questionnaire (RCSQ).
Time frame: From end of surgery to 3 days after surgery
Postoperative anxiety
The anxiety after surgery will be evaluated daily for the first 2 postoperative days using Visual Analog Scale for Anxiety (NRS-anxiety).
Time frame: From end of surgery to 2 days after surgery
Postoperative delirium
The postoperative delirium will be evaluated twice a day for the first 3 postoperative days using 3-Minute Diagnostic Interview for CAM (3D-CAM).
Time frame: From end of surgery to 3 days after surgery
Length of Hospital Stay
Length of hospital stay measured as the number of days from the date of surgery to hospital discharge.
Time frame: Through hospital discharge, up to 14 days
Adverse Effects
Incidence of nausea or vomiting, acute urinary retention, drowsiness, pruritus, and dizziness or any other reported complications will be recorded.
Time frame: From end of surgery to 3 days after surgery
Gut microbiota
Gut microbiota diversity (α and β), and correlation between relative abundance of specific microbial taxa and the effect of opioid-sparing anesthesia will be analyzed.
Time frame: From 1 day before surgery to 2 days after surgery
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