A Phase 4 interventional study of Esketamine combined with dexmedetomidine and saline placebo in Chronic Pain, Postoperative, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 4, Interventional, and Prevention
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:
Participants will:
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 450 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 490 studies on the registry; 289 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Esketamine combined with dexmedetomidine
Drug: saline placebo
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.
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.
Incidence of Chronic Pain at 3 Months After Pancreatic Surgery
The outcome measure reports the number and proportion of participants with chronic postsurgical pain (CPSP) at 3 months after pancreatic surgery. CPSP is assessed using the Chronic Postsurgical Pain (CPSP) Scale, a yes/no questionnaire. Participants are classified as having CPSP if they meet the following criteria: (1) pain lasting 3 months or longer after surgery; (2) pain is new after surgery or more painful than before surgery; (3) pain is localized to the surgical area; and (4) other causes of pain, such as local recurrence, infection, or metastasis, are excluded. The scale does not produce a numerical score.
Time frame: At 3 months after pancreatic surgery
Cumulative Opioid Consumption Within 3 Days After Surgery
Cumulative opioid consumption within 3 days after surgery is a continuous measure of the total amount of opioids administered during the first 3 postoperative days . It is assessed from patient-controlled intravenous analgesia (PCIA) pump records and nursing medication administration records. The PCIA pump records the total volume of analgesic solution used; because the sufentanil concentration in the PCIA solution is known (sufentanil 1.5 μg/kg in 100 mL in both groups), the cumulative sufentanil dose delivered via PCIA is calculated. Any additional opioid rescue analgesia administered during this period (e.g., intravenous sufentanil boluses) is also recorded and included.
Time frame: From the end of surgery to 3 days after surgery
Sleep Quality on the First 3 Postoperative Nights
Sleep quality during the first 3 postoperative nights is assessed on the mornings of postoperative days 1, 2, and 3 (8:00-10:00) for the previous night. Subjective sleep quality is measured using the Richards-Campbell Sleep Questionnaire (RCSQ) and a sleep Numeric Rating Scale (NRS). The RCSQ consists of 6 items, each scored on a 0-100 visual analogue scale, with higher scores indicating better sleep quality. The sleep NRS ranges from 0 to 10, where 0 indicates the best possible sleep quality and 10 indicates the worst possible sleep quality; therefore, higher NRS scores indicate worse sleep quality.
Time frame: During the first 3 nights after surgery
Length of Postoperative Hospital Stay
This outcome measure reports the length of postoperative hospital stay as a continuous variable, measured in days. It is defined as the number of days from the date of surgery to the date of hospital discharge, as documented in the hospital medical record.
Time frame: From the day of surgery to hospital discharge
Incidence of Postoperative Complications, Including All-Cause Mortality, Within 30 Days After Surgery
This outcome measure reports the incidence of participants who experience at least one postoperative complication, including all-cause mortality, within 30 days after pancreatic surgery. Pre-specified examples of complications include cardiac complications (myocardial injury or myocardial infarction, new-onset arrhythmia, acute heart failure, cardiac arrest), stroke, pulmonary complications (pneumonia, pulmonary aspiration, atelectasis, acute respiratory distress syndrome), acute renal insufficiency, gastrointestinal complications (gastrointestinal infarction, gastrointestinal bleeding, gastrointestinal perforation, intestinal obstruction), and unplanned readmission.
Time frame: Within 30 days after surgery
Depression Score at 3 Months After Surgery
Depression at 3 months after surgery is assessed using the Patient Health Questionnaire-9 (PHQ-9) , a 9-item self-reported depression screening questionnaire. Each item is scored from 0 to 3, and the total PHQ-9 score ranges from 0 to 27. A higher total score indicates more severe depressive symptoms.
Time frame: At 3 months after surgery
EORTC QLQ-PAN26 Score at 3 Months After Surgery
The outcome measure reports the EORTC QLQ-PAN26 score at 3 months after surgery. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module 26 (EORTC QLQ-PAN26) is a 26-item, pancreatic cancer-specific, patient-reported quality-of-life questionnaire module. Each item is rated on a 4-point Likert scale (1 = Not at all, 2 = A little, 3 = Somewhat, 4 = Very much).For symptom items, higher scores indicate more severe symptoms. For functional items, higher scores indicate better quality of life.
Time frame: At 3 months after surgery
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tianjin Medical University Cancer Institute and Hospital →