Not Yet RecruitingPhase 4ketamine

Effect of Low-Dose Esketamine Combined With Dexmedetomidine on the Incidence of Chronic Postsurgical Pain in Patients Undergoing Pancreatic Surgery

Sponsored by Tianjin Medical University Cancer Institute and Hospital

NCT ID
NCT07888413
Target Enrollment
450 participants
Start Date
2026-12-01
Est. Completion
2029-11-30

About This Study

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.

Conditions Studied

Chronic Pain, Postoperative

Interventions

  • •Esketamine combined with dexmedetomidine
  • •saline placebo

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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 \<50 beats/min), or second-degree or higher atrioventricular block without an implanted pacemaker; New York Heart Association (NYHA) functional class ≥ III.
3. Preoperative diagnosis of sleep apnea, or STOP-Bang questionnaire score ≥3.
4. Preoperative hyperthyroidism or a history of pheochromocytoma.
5. Preoperative neuropsychiatric disorders, such as severe depression with suicidal ideation, dementia, schizophrenia, epilepsy, myasthenia gravis, and delirium.
6. Severe hepatic impairment (Child-Pugh class C); severe renal impairment (receiving preoperative dialysis); ASA class ≥ IV.
7. Unable to understand the visual analog scale or has language communication difficulties.

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source