Dexmedetomidine-esketamine Combination and Moderate-to-severe Pain After Spinal Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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 sufentanil 1.25 ug/h) 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 (sufentanil 1.25 ug/h) 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 improve analgesia and reduce moderate-to-severe pain in patients after spinal surgery.

Eligibility

Primary outcome measure(s)

• Incidence of moderate-to-severe pain within 72 hours after surgery — Up to 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.

Trial sites (1)

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