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Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Summary
The goal of this clinical trial is to learn if low-dose esketamine combined with dexmedetomidine can reduce chronic pain after pancreatic surgery in adults. It will also learn about its safety. The main questions it aims to answer are: * Does low-dose esketamine combined with dexmedetomidine lower the number of participants who have chronic pain 3 months after pancreatic surgery? * What medical problems do participants have when receiving this treatment? Researchers will compare low-dose esketamine combined with dexmedetomidine to a control group (saline placebo during surgery and standard sufentanil patient-controlled intravenous analgesia after surgery) to see if the study treatment reduces chronic pain after pancreatic surgery. This is a two-center randomized controlled trial. About 450 adults will be enrolled and randomly assigned to the treatment group or the control group. Participants will: * Be adults aged 18 years or older, weigh at least 40 kg, and be scheduled for elective pancreatic surgery, including pancreaticoduodenectomy (Whipple procedure), pancreatectomy, or distal pancreatectomy. * Receive the study drugs or placebo during surgery and use a patient-controlled intravenous pain pump after surgery. * Be followed for up to 3 months after surgery to check for chronic pain.
Official title: Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery: A Two-Center Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2026-12-01
Completion Date
2029-11-30
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
Esketamine combined with dexmedetomidine
Intraoperative study drug: dexmedetomidine 1 mcg/mL + esketamine 0.5 mg/mL in 50 mL. Loading dose 0.3 mL/kg (dexmedetomidine 0.3 mcg/kg + esketamine 0.15 mg/kg) infused over 10 min, followed by continuous infusion 0.2 mL/kg/h (dexmedetomidine 0.2 mcg/kg/h + esketamine 0.1 mg/kg/h) until 30 min before the end of surgery. Postoperative patient-controlled intravenous analgesia (PCIA): dexmedetomidine 1 mcg/mL + esketamine 0.5 mg/mL + sufentanil 1.5 mcg/kg in 100 mL. Continuous infusion 1 mL/h; bolus 2 mL per demand; lockout interval 8 min.
saline placebo
Intraoperative placebo: normal saline in identical syringes and pump, administered using the same loading and continuous infusion regimen as the intervention group. Postoperative PCIA: sufentanil 1.5 mcg/kg in 100 mL, using an identical patient-controlled intravenous analgesia pump. Continuous infusion 1 mL/h; bolus 2 mL per demand; lockout interval 8 min.