Opoid Managment, Pain Management
Conditions
Keywords
Opioid-sparing anesthesia, Opioid consumption, postoperative pain, elderly patients, spine surgery
Brief 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.
Interventions
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.
DRUGRoutine 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 65 years * Undergoing multilevel level (≥2 levels) spine surgery under general anesthesia * Able to provide written informed consent
Exclusion criteria
* Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication * Pregnant or breastfeeding * Patients with contraindications to any of the medications in the study protocol (unstable angina, recent myocardial infarction, cerebral or aortic aneurysms, increased intracranial pressure, increased intraocular pressure, psychosis or schizophrenia, pheochromocytoma, epilepsy, second- or third-degree atrioventricular block, bradycardia (heart rate \< 50bpm), liver failure, hypotension (systolic BP \<80 mmHg)) * Drug or alcohol abuse * Refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | From end of surgery to 24 hours after surgery | Total morphine equivalent consumption during the first 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (NRS) | From end of surgery to postoperative 72 hours | 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 to First Rescue Analgesia | From end of surgery to the administration of the first rescue analgesic | The exact time (in hours and minutes) from the end of surgery to the administration of the first rescue analgesic will be recorded. |
| Total Analgesic Consumption | From end of surgery to postoperative 72 hours | 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 to first postoperative flatus | Up to 72 hours postoperatively | The exact time (in hours and minutes) from the end of surgery to the first postoperative flatus will be recorded. |
| Quality of recovery | At 1 day after surgery | The quality of recovery after surgery will be evaluated using Quality of Recovery-15 (QoR-15) at 1 day after surgery. |
| Sleep quality | From end of surgery to 3 days after surgery | The sleep quality after surgery will be evaluated daily for the first 3 postoperative days using Richards-Campbell Sleep Questionnaire (RCSQ). |
| Postoperative anxiety | From end of surgery to 2 days after surgery | The anxiety after surgery will be evaluated daily for the first 2 postoperative days using Visual Analog Scale for Anxiety (NRS-anxiety). |
| Postoperative delirium | From end of surgery to 3 days after surgery | The postoperative delirium will be evaluated twice a day for the first 3 postoperative days using 3-Minute Diagnostic Interview for CAM (3D-CAM). |
| Length of Hospital Stay | Through hospital discharge, up to 14 days | Length of hospital stay measured as the number of days from the date of surgery to hospital discharge. |
| Adverse Effects | From end of surgery to 3 days after surgery | Incidence of nausea or vomiting, acute urinary retention, drowsiness, pruritus, and dizziness or any other reported complications will be recorded. |
| Gut microbiota | From 1 day before surgery to 2 days after surgery | 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. |
Outcome results
None listed