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Dexmedetomidine-esketamine Combination and Moderate-to-severe Pain After Spinal Surgery
Sponsor: Peking University First Hospital
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.
Official title: Effect of Perioperative Use of Dexmedetomidine-esketamine Combination on Incidence of Moderate-to-severe Pain After Spinal Surgery: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2026-04
Completion Date
2027-05
Last Updated
2026-04-13
Healthy Volunteers
No
Interventions
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.
Locations (1)
Peking University First Hospital
Beijing, Beijing Municipality, China