Dexmedetomidine-esketamine Combination and Moderate-to-severe 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 improve analgesia and reduce moderate-to-severe pain in patients after spinal surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged >= 40 years but < 80 years;
Scheduled to undergo elective posterior cervical, thoracic, or lumbar spine surgery with an expected duration >= 2 hours under general anesthesia;
Required patient-controlled intravenous analgesia (PCIA) after surgery.
Disqualifiers
Uncontrolled preoperative hypertension (ward systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg);
Severe bradycardia (heart rate <= 50 bpm), sick sinus syndrome, atrioventricular block of grade II or higher without pacemaker implantation, a history of myocardial infarction within one year, or presence of rapid ventricular arrhythmia;
History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or prresence of intracranial hypertension;
Uncontrolled 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 sufentanil 1.25 ug/h) 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 (sufentanil 1.25 ug/h) 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 moderate-to-severe pain within 72 hours after surgery
Pain intensity will be assessed at 1 and 6 hours, and then twice daily (8:00-10:00, 18:00-20:00) until 72 hours after surgery, using the Numerical Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) both at rest and with movement (e.g., bed turning, walking). NRS pain scores 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain.
Time frame
Up to 72 hours after surgerySecondary outcomes
1
Incidence of delayed neurocognitive recovery at postoperative day 5
Cognitive function will be assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher scores indicating better function) at baseline and on the 5th day or before hospital discharge after surgery. Delayed neurocognitive recovery is defined as a decline of MoCA score of \>= 1 stndard deviation (SD) from baseline.
Time frame
Up to 5 days after surgery2
Incidence of cardiovascular events within 30 days after surgery
Cardiovascular events include myocardial injury after non-cardiac surgery (MINS; including myocardial infarction), non-fatal cardiac arrest, stroke, and all-cause mortality. The diagnosis of MINS will strictly follow the consensus of the American Heart Association (AHA).
Time frame
Up to 30 days after surgeryOther outcomes
1
Area under curve of pain intensity within 72 hours postoperatively
Pain intensity will be assessed at 1 and 6 hours, and then twice daily (8:00-10:00, 18:00-20:00) until 72 hours after surgery, using the Numerical Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) both at rest and with movement (e.g., bed turning, walking).
Time frame
Up to 72 hours after surgery2
Consumption of sufentanil-equivalent dose within 72 hours postoperatively
Opioid consumption within 72 hours after surgery will be converted to a sufentanil-equivalent dose.
Time frame
Up to 72 hours after surgery3
Quality of recovery score at 24 and 72 hours postoperatively
Quality of recovery will be assessed at 24 and 72 hours after surgery, using the 15-item quality of recovery scale (QoR-15; scores range from 0 to 150 points, with higher scores indicating better recovery).
Time frame
Up to 72 hours after surgery4
Subjective sleep quality during the first three postoperative nights
Subjective sleep quality will be assessed once daily (8:00-10:00) during the first 3 days after surgery, using the Numeric Rating Scale (NRS; scores range from 0 to 10 with 0=the best sleep quality and 10=the worst sleep quality).
Time frame
Up to 72 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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