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Clinical Trial NCT07179913 (esketamine) for Depressed, Bariatric Surgery is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression (esketamine) Phase 4 40

Not yet recruiting
Clinical Trial NCT07179913 (esketamine) is designed to study Other for Depressed, Bariatric Surgery. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 10 September 2025 until the study accrues 40 participants. Led by The First Hospital of Jilin University, this study is expected to complete by 10 September 2026. The latest data from ClinicalTrials.gov was last updated on 18 September 2025.
Brief Summary
The aim of this study is to observe the antidepressant effect of low-dose esketamine in obese patients with preoperative depression and seeking bariatric surgery. We speculate that intraoperative infusion and the addition of a small dose of esketamine to the postoperative analgesic pump can help reduce the proportion of patients with depression after surgery, and may further improve postoperative recovery, reduce the...Show More
Official Title

The Improvement of Low-dose Esketamine on Postoperative Depression in Patients Undergoing Bariatric Surgery With Preoperative Depression:A Prospective Radomized Controlled Trial

Conditions
DepressedBariatric Surgery
Other Study IDs
  • esketamine
  • 25K322-001
NCT ID Number
NCT07179913
Start Date (Actual)
2025-09-10
Last Update Posted
2025-09-18
Completion Date (Estimated)
2026-09-10
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
esketamine
bariatric surgery
depression
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo Comparatordexmedetomidine
Dexmedetomidine
For the control group subjects, dexmedetomidine at a dose of 0.2mg/2ml was diluted with normal saline up to 50ml(dexmedetomidine concentration of 4μg/ml), anesthesia induction begins with intravenous infusion of 0.5μg/kg (0.083ml/kg•h), with a pumping duration of 40 minutes. The postoperative analgesic pump was added after the operation dilute with normal saline at a dose of 0.5μg/kg of dexmedetomidine and 1.5 μg/kg ...Show More
Experimentalesketamine
Esketamine
For the subjects in the experimental group, esketamine 50mg/2ml was diluted with normal saline up to 50ml (with a concentration of esketamine at 1mg/ml), anesthesia induction begins with intravenous infusion of esketamine 0.25mg/kg (0.375ml/kg•h drug preparation solution), with a pumping duration of 40 minutes.After the operation, esketamine 0.25mg/kg and sufentanil 1.5ug/kg were added to the postoperative analgesic ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Hamilton Depression Scale ≥7
The proportion of patients with depression (Hamilton Depression score ≥7)
Seven days after the operation
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
the proportion of patients with depression
The proportion of patients with depression
30 days, 3 months, 6 month and 1 year after the operation
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Age ≥18 years old and <65 years old
  • Patients with a BMI greater than 35 kg/m^2
  • Hamilton Depression score ≥7 points
  • Planned to undergo elective laparoscopic sleeve gastrectomy

  • ASA ≥ grade IV
  • Those who have had or are currently suffering from mental disorders other than anxiety and depression, such as schizophrenia, bipolar disorder, organic mental disorders, etc.
  • Those who are unable to cooperate in completing the scale assessment
  • Have received ketamine/esketamine treatment, or are allergic to ketamine/esketamine
  • Clarify ischemic cardiomyopathy or severe liver and kidney dysfunction (Child pugh grade C, CKD stage G5)
  • People with opioid dependence and those who have been taking various types of painkillers for a long time (more than 3 months)
  • Participate in other research
The First Hospital of Jilin University logoThe First Hospital of Jilin University
Study Responsible Party
lizhiwen, Principal Investigator, study director, The First Hospital of Jilin University
Study Central Contact
Contact: Dongdong Cao, Medicine doctoral student, +8618243008603, [email protected]
No location data.