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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1：Opioid-Sparing Anesthesia | Experimental | Participants assigned to Group 1 will receive opioid-sparing anesthesia strategy. Continuous intravenous infusion of ketamine (5 μg/kg/min) and dexmedetomidine (0.6 μg/kg/h) will be initiated from induction and maintained until one hour before the anticipated end of surgery. 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. |
|
| Group 2：Routine Anesthesia | Active Comparator | Participants assigned to Group 2 will receive routine anesthesia management. During induction, fentanyl 100 μg will be administered intravenously. If needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-Sparing Protocol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Total morphine equivalent consumption during the first 24 hours after surgery | From end of surgery to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From end of surgery to postoperative 72 hours |
| Time to First Rescue Analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41814842 | Background | Xu M, Zhu R, She YJ, Sun Y, Xu L, Rosenquist R, Yao M, Han X, Xu J. Perioperative Ketamine and Esketamine for Enhanced Recovery After Surgery (ERAS): A Systematic Review. J Invest Surg. 2026 Dec;39(1):2637241. doi: 10.1080/08941939.2026.2637241. Epub 2026 Mar 11. | |
| 41527017 | Background | Sun Y, Yao Y, Li Y, Deng W. Dexmedetomidine for opioid-sparing postoperative analgesia: a systematic review and meta-analysis. BMC Anesthesiol. 2026 Jan 13;26(1):103. doi: 10.1186/s12871-025-03606-w. |
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Individual participant data (IPD) will not be shared due to concerns about patient privacy and the sensitive nature of the data collected.
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| Routine anesthesia protocol | Drug | 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. |
|
The exact time (in hours and minutes) from the end of surgery to the administration of the first rescue analgesic will be recorded. |
| 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | From 1 day before surgery to 2 days after surgery |
| 39709188 | Background | Ervin-Sikhondze BA, Gunaseelan V, Chua KP, Bicket MC, Waljee JF, Englesbe MJ, Brummett CM. Opioid consumption in the first 30 days after surgery was independently associated with new persistent opioid use. Reg Anesth Pain Med. 2026 Mar 5;51(3):317-323. doi: 10.1136/rapm-2024-106068. |
| 39262217 | Background | Mathew J, Gum JL, Carreon LY, Sampedro BC, Harpe-Bates J, Hines BP, Brown ME, Daniels CL, Mkorombindo T, Glassman SD. Opioid Sparing Anesthesia for Adult Spinal Deformity Surgery Reduces Postoperative Pain, Length of Stay, Opioid Consumption, and Opioid-Related Complications: A Propensity-Matched Analysis. Spine (Phila Pa 1976). 2025 Jun 15;50(12):804-808. doi: 10.1097/BRS.0000000000005159. Epub 2024 Sep 12. |
| 40625006 | Background | Yu C, Madsen M, Akande O, Oh MY, Mattie R, Lee DW. Narrative Review on Postoperative Pain Management Following Spine Surgery. Neurospine. 2025 Jun;22(2):403-420. doi: 10.14245/ns.2550410.205. Epub 2025 Jun 30. |
| 26827847 | Background | Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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