Effect of Esketamine on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
NCT06199011, Not applicable, Unknown, The Second Hospital of Anhui Medical University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Esketamine on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy | ClinicalTrials.gov |
| NCT number | NCT06199011 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 400 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | The Second Hospital of Anhui Medical University | ClinicalTrials.gov |
| Conditions | Depressive Symptoms | ClinicalTrials.gov |
| Interventions | Esketamine hydrochloride, Opioid | ClinicalTrials.gov |
| First posted | 2024-01-10 | ClinicalTrials.gov |
| Last updated | 2024-01-10 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hamilton depression Rating Scale | Before surgery and at the postoperative 3 months | The 24-item version of the Hamilton Depression Scale (HAM-D) is used to assess the severity of depression. Each item is rated on the Likert scale, ranging from 0 to 4. The normal value is 0-7 points, the mild depression value is 8-20 points, the moderate depression symptom value is 21-35 points, and the severe depression value exceeds 35 points. The higher scores indicate the worse symptoms. | ClinicalTrials.gov |
| Secondary | Postoperative anxiety | In 3 months after surgery | Postoperative anxiety | ClinicalTrials.gov |
| Secondary | Hamilton Anxiety Rating Scale | Before surgery and at the postoperative 3 months | Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety. Total score ranges from 0 to 56, the higher the score is, the more serious the anxiety is. | ClinicalTrials.gov |
| Secondary | Cognition | Before surgery and at the postoperative 3 months | AVLT, Trail Making Tests, Stroop color and word test, word fluency, Digit span test will be used to evaluate the cognition. | ClinicalTrials.gov |
| Secondary | The incidence of Postoperative nausea and vomiting | At 0-24 hours after surgery | The incidence of Postoperative nausea and vomiting | ClinicalTrials.gov |
| Secondary | Postoperative depressive symptoms | In 3 months after surgery | Montgomery-Asberg Depression Rating Scale (MARDS) includes 10 items. The normal value is less than 12 points, the mild depression value is 12-22 points, the moderate depression symptom value is 22-30 points, and the severe depression value is 30-35 points, extreme severe depression value exceeds 35. The higher scores indicate the worse symptoms. | ClinicalTrials.gov |
| Secondary | Postoperative pain | At 0-24 hours after surgery | Postoperative incision pain and visceral pain will be assessed by VAS withing 0-10. The higher scores indicate the more pain. | ClinicalTrials.gov |
| Secondary | Time to the first rescue analgesics | At 0-24 hours after surgery | The time from extubation to the first rescue analgesics | ClinicalTrials.gov |
| Secondary | Time to the first rescue antiemetics | At 0-24 hours after surgery | The time from extubation to the first rescue antiemetics | ClinicalTrials.gov |
| Secondary | Consumption of anesthetics | During the surgery | Total usage of anesthetics during the surgery | ClinicalTrials.gov |
| Secondary | Length of surgery | At the end of surgery | From beginning to the end of surgery | ClinicalTrials.gov |
| Secondary | Length of anesthesia | At the end of anesthesia | From beginning to the end of anesthesia | ClinicalTrials.gov |
| Secondary | QoR-15 | At 24 hours after surgery | The QoR-15 is a convenient patient-reported tool, including 15 items of five domains (pain, comfort, physical independence, psychological support, and emotional state) with each item ranging from 0 to 10. Higher scores suggest better quality of recovery (0-89, poor recovery; 90-121, moderate recovery; 122-135, good recovery; 136-150, excellent recovery) | ClinicalTrials.gov |
| Secondary | Adverse event rate | During postoperative 3 months | The incidence of adverse events | ClinicalTrials.gov |
| Secondary | BMI | Before surgery and at the postoperative 3 months | Body mass index | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index | Before surgery and at the postoperative 3 months | Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep. | ClinicalTrials.gov |
| Secondary | Gastrointestinal Symptom Rating Scale | Before surgery and at the postoperative 3 months | Gastrointestinal Symptom Rating Scale (GSRS) will be used to assess gastrointestinal function. The score ranges from 0-45. The higher score means poorer gastrointestinal function. | ClinicalTrials.gov |
| Secondary | Quality of health and functional status | Before surgery and at the postoperative 3 months | SF-36 consists of 36 items and is a short questionnaire to evaluate the health and functional status within one month. There are 8 dimensions regarding physiological functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. For each item, the average is 50 points, 0 is the lowest and 100 is the highest. The conversion score for each item is (the exact score minus the suspected lowest score) / (the difference between the expected highest and lowest score) × 100. The total score of the 8 dimensions is the total score of the scale. | ClinicalTrials.gov |
| Secondary | Brain function | Before surgery and at the postoperative 3 months | Resting functional magnetic resonance imaging (rs-fMRI) will measure brain structure and functional changes, including gray matter volume, gray matter thickness, functional connectivity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)