Depressive Symptoms
Conditions
Brief summary
Esketamine, as a powerful analgesic intravenous anesthetic, has a rapid onset and elimination effect, does not inhibit spontaneous respiration, and can slightly stimulate the circulatory system. It has been confirmed that esketamine can effectively combat opioid related complications, especially life-threatening respiratory suppression. Thus becoming a new powerful perioperative analgesic drug. At the same time, esketamine has been licensed for the treatment of resistant depression and emergency treatment for patients in crisis states of depression. But the evidence for its safety and effectiveness is insufficient. We have designed a randomized controlled clinical trial to investigate the effect of an established general anesthesia strategy without opioids by using esketamine on postoperative depressive in obese patients undergoing laparoscopic sleeve gastrectomy.
Detailed description
The bidirectional relationship between obesity and mood disorders is suggested supported by empirical evidence. Obesity increases the risk of depression, and depression predicts the developing of obesity. The associations between atypical depressive symptoms and obesity-related characteristics may consequent to sharing pathophysiologic characteristics in patients with major depressive disorders, such as genetics, and brain circuitries integrating homeostatic and mood regulatory responses. Bariatric surgery is a remarkably effective and durable treatment for obesity, resulting in considerable weight loss, and reductions in the prevalence of type 2 diabetes mellitus, hypertension, dyslipidemia and sleep apnea at 5 years. Nearly 23-33% of patients undergoing bariatric surgery report a preoperative depression. Meanwhile, bariatric surgery is consistently associated with postoperative decreases in the prevalence of depression (8%-74% decrease) and the severity of depressive symptoms (40%-70% decrease) at 6-month, 12-month, 24-month. In 357 extremely obese patients with a mean BMI of 51.2 kg/m2, 45% of patients are identified as depression before gastric bypass surgery. And by 6-, 12-, 24-month follow-up, by using Beck Depression Inventory, clinically significant depressive symptoms are characterized to 12%, 13% and 18%, respectively. Compared with status prior to surgery, the prevalence of any Axis I psychiatric disorder for DSM-IV at 2 and 3 years after Roux-en-Y gastric bypass or laparoscopic adjustable gastric band surgery is significantly reduced from 30.2% to 16.8% and 18.4%. Based on the HAMD assessments, we found that the incidence of depressive symptoms was 71.1% in 225 young obese patients (31.0 years-old) before laparoscopic sleeve gastrectomy. The depressive symptoms and severity were improved over time, particular in postoperative 3 months. However, depressive symptoms were still sustained in a proportion of obese patients.
Interventions
A standardized non-opioid anesthesia will be achieved by using continuous intraoperative infusion of esketamine.
DRUGOpioid
A standardized opioid anesthesia will be achieved by using continuous intraoperative infusion of opioids.
Sponsors
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* BMI≥40kg/m2 or BMI\>35 kg/m2 with an existing comorbidity * scheduled for selective LSG * American Society of Anesthesiologists physical status I-III * HAMD\>7 * with informed consent
Exclusion criteria
* Patients diagnosed with significant comorbidities, such as cardiopathy, chronic respiratory conditions, abnormal hepatic and/or renal function, coagulation dysfunction, major psychiatric or neurological disorders * Patients allergy to esketamine or other drugs used in the study * Patients are scheduled for/plan to have an additional surgery during the 3-month follow-up period * Patients suffer from acute or chronic pain with analgesics, or take anticathartic, glucocorticoid medications * Patients involved in another research study * Patients will likely have problems, in the judgement of the investigator, with maintaining follow-up * Any other reasons the investigator feels is relevant for excluding the patient * lack of patient consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| The incidence of Postoperative nausea and vomiting | At 0-24 hours after surgery | The incidence of Postoperative nausea and vomiting |
| 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. |
| 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. |
| Time to the first rescue analgesics | At 0-24 hours after surgery | The time from extubation to the first rescue analgesics |
| Time to the first rescue antiemetics | At 0-24 hours after surgery | The time from extubation to the first rescue antiemetics |
| Consumption of anesthetics | During the surgery | Total usage of anesthetics during the surgery |
| Postoperative anxiety | In 3 months after surgery | Postoperative anxiety |
| Length of anesthesia | At the end of anesthesia | From beginning to the end of anesthesia |
| 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) |
| Adverse event rate | During postoperative 3 months | The incidence of adverse events |
| BMI | Before surgery and at the postoperative 3 months | Body mass index |
| 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. |
| 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. |
| 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. |
| 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. |
| Length of surgery | At the end of surgery | From beginning to the end of surgery |
Contacts
Primary ContactChunxia Huang, PhD
Outcome results
None listed