Combined dexmedetomidine-esketamine administration: During anesthesia, a loading dose (0.2 ml/kg) of dexmedetomidine-esketamine (DEX-ESK) combination (DEX 2 ug/ml; ESK 1 mg/ml) will be infused after anesthesia induction (DEX 0.4 ug/kg; ESK 0.2 mg/kg), followed by a continuous infusion at 0.1 ml/kg/h (DEX 0.2 ug/kg/h; ESK 0.1 mg/kg/h) until 1 hour before the expected end of surgery.
After surgery, patient-controlled intravenous analgesia will be established with dexmedetomidine (DEX 1.5 ug/ml), esketamine (ESK 0.5 mg/ml), and sufentanil (1.25 ug/ml), programmed to deliver 2-ml boluses (DEX 3.0 ug, ESK 1 mg, and sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml/h (DEX 1.5 ug/h, ESK 0.5 mg/h, and 1.25 ug/h sufentanil) background infusion, and used for up to 48 hours.
Placebo administration: During anesthesia, a loading dose (0.2 ml/kg) of normal saline will be infused after anesthesia induction, followed by a continuous infusion at 0.1 ml/kg/h until 1 hour before the expected end of surgery.
After surgery, patient-controlled intravenous analgesia will be established with sufentanil (1.25 ug/ml), programmed to deliver 2-ml boluses (sufentanil 2.5 ug) with a 8-10-minute lockout interval and a 1-ml/h (1.25 ug/h sufentanil) background infusion, and used for up to 48 hours.
Study summary
Spinal surgery is generally followed by severe postoperative pain, and poor pain control may cause adverse outcomes such as cardiovascular events, neurocognitive disorders, and chronic postsurgical pain (CPSP). In previous studies, perioperative use of dexmedetomidine or esketamine is each associated with improved analgesia after surgery. Recent studies suggest that combined use of dexmedetomidine and esketamine may produce synergetic effects in improving analgesia. This trial is designed to test the hypothesis that perioperative combined use of dexmedetomidine and esketamine may reduce CPSP in patients after spinal surgery.
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged \>= 40 years and \< 80 years;
2. Scheduled to undergo elective posterior cervical, thoracic or lumbar spine surgery under general anesthesia, with an expected operative duration \>= 2 hours;
3. Requirement for patient-controlled intravenous analgesia (PCIA) postoperatively.
Exclusion Criteria:
1. Severe uncontrolled hypertension preoperatively (baseline ward blood pressure: SBP \> 180 mmHg or DBP \> 110 mmHg);
2. Severe bradycardia (heart rate \<= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, or a history of myocardial infarction within one year, severe heart failure (NYHA class \>= III), or rapid ventricular arrhythmia;
3. Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
4. Preoperative history of hyperthyroidism or pheochromocytoma;
5. Inability to communicate preoperatively due to coma, severe dementia, or language impairment;
6. Severe cardiac insufficiency (preoperative LVEF \< 30% or NYHA class IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (preoperative dialysis), or ASA physical status \>= grade IV;
7. Other conditions deemed inappropriate for study participation by the investigator or attending physician.
Primary outcome measure(s)
Incidence of chronic pain at 3 months after surgery — Up to 3 months after surgery. Chronic post-spinal surgery pain is a specific type of Chronic Postsurgical Pain (CPSP), defined as pain lasting \>=3 months postoperatively after exclusion of other known causes. The presence of persistent pain beyond the postoperative recovery period is confirmed if any one of the following three criteria is met (either alone or in combination):
1. Any additional lumbar spine surgery within 3 months after the index surgery;
2. At least one pain-related physician visit within 3 months after the index surgery;
3. Any other surgical intervention for pain management at any time after surgery (not limited to 24 months), such as neuromodulation or implantation of a drug delivery system.
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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