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NOT YET RECRUITING
NCT07588802
PHASE2

Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Elderly Patients Undergoing Spine Surgery

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Spine Surgery

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-07

Completion Date

2027-05

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

DRUG

Opioid-Sparing Protocol

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.

DRUG

Routine anesthesia protocol

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.