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NCT07888413
Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery
Conditions: Chronic Pain, Postoperative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 450
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years.
2. Body weight ≥40 kg.
3. Scheduled for elective pancreatic surgery, including pancreaticoduodenectomy (Whipple procedure), pancreatectomy, or distal pancreatectomy.
4. Planned use of postoperative patient-controlled intravenous analgesia (PCIA).
Exclusion Criteria:
1. Refusal to participate in this study.
2. Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \
Source: ClinicalTrials.gov (NCT07888413). StuddyBuddy aggregates publicly available trial information.