Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPeking University First Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged >= 40 years and < 80 years;
Scheduled to undergo elective posterior cervical, thoracic or lumbar spine surgery under general anesthesia, with an expected operative duration >= 2 hours;
Requirement for patient-controlled intravenous analgesia (PCIA) postoperatively.
Disqualifiers
Severe uncontrolled hypertension preoperatively (baseline ward blood pressure: SBP > 180 mmHg or DBP > 110 mmHg);
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;
Preoperative history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
Preoperative history of hyperthyroidism or pheochromocytoma;
Trial design
Design model
Parallel
Treatments tested in this trial
Combined dexmedetomidine-esketamine administration
DrugDuring 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
DrugDuring 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.
Treatment groups
274 Participants
are divided into 2 treatment groupsGroup A: Combined dexmedetomidine-esketamine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of chronic pain at 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.
Time frame
Up to 3 months after surgery.Secondary outcomes
1
Incidence of chronic pain at 6 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 between 3 and 6 months after the index surgery; 2. At least one pain-related physician visit within between 3 and 6 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.
Time frame
Up to 6 months after surgery.Other outcomes
1
Pain scores (Numerical Rating Scale, NRS) at 3 and 6 months after surgery
Assesses pain intensity at 3 and 6 months post-surgery via the NRS scale (0=no pain, 10=worst imaginable pain), with patients rating pain at rest and during activity through telephone follow-up.
Time frame
Up to 6 months after surgery.2
Incidence of neurocognitive disorders at 3 and 6 months postoperatively
Postoperative neurocognitive disorder was defined as a decrease in T-MoCA score of \>= 1 standard deviation (SD) from baseline.
Time frame
Up to 6 months after surgery.3
Oswestry Disability Index (ODI) at 3 and 6 months postoperatively
Evaluates spinal-related functional impairment at 3 and 6 months post-surgery via the ODI scale (0-100%), with patients rating disability from back/leg pain across 10 daily life domains; higher scores mean greater functional impairment (assessed by telephone follow-up).
Time frame
Up to 6 months after surgery.Sponsors and contacts
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Source ClinicalTrials.gov
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