Effect of Esketamine on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Depressive Symptoms Clinical Trial

— EDSOP  

Official title:

Effect of Intraoperative Esketamine Infusion on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06199011
• Other study ID #: EDSOP
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2023
• Source: The Second Hospital of Anhui Medical University
• Contact: Chunxia Huang, PhD
• Phone: +8613500512159
• Email: huangchunxia[@]ahmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Drug:
• Esketamine hydrochloride
A standardized non-opioid anesthesia will be achieved by using continuous intraoperative infusion of esketamine.
• Opioid
A standardized opioid anesthesia will be achieved by using continuous intraoperative infusion of opioids.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression Rating Scale	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.	Before surgery and at the postoperative 3 months
Secondary	Postoperative anxiety	Postoperative anxiety	In 3 months after surgery
Secondary	Hamilton Anxiety Rating Scale	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.	Before surgery and at the postoperative 3 months
Secondary	Cognition	AVLT, Trail Making Tests, Stroop color and word test, word fluency, Digit span test will be used to evaluate the cognition.	Before surgery and at the postoperative 3 months
Secondary	The incidence of Postoperative nausea and vomiting	The incidence of Postoperative nausea and vomiting	At 0-24 hours after surgery
Secondary	Postoperative depressive symptoms	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.	In 3 months after surgery
Secondary	Postoperative pain	Postoperative incision pain and visceral pain will be assessed by VAS withing 0-10. The higher scores indicate the more pain.	At 0-24 hours after surgery
Secondary	Time to the first rescue analgesics	The time from extubation to the first rescue analgesics	At 0-24 hours after surgery
Secondary	Time to the first rescue antiemetics	The time from extubation to the first rescue antiemetics	At 0-24 hours after surgery
Secondary	Consumption of anesthetics	Total usage of anesthetics during the surgery	During the surgery
Secondary	Length of surgery	From beginning to the end of surgery	At the end of surgery
Secondary	Length of anesthesia	From beginning to the end of anesthesia	At the end of anesthesia
Secondary	QoR-15	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)	At 24 hours after surgery
Secondary	Adverse event rate	The incidence of adverse events	During postoperative 3 months
Secondary	BMI	Body mass index	Before surgery and at the postoperative 3 months
Secondary	Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI) will be assessed the quality of sleep. The higher score means the lower quality of sleep.	Before surgery and at the postoperative 3 months
Secondary	Gastrointestinal Symptom Rating Scale	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.	Before surgery and at the postoperative 3 months
Secondary	Quality of health and functional status	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.	Before surgery and at the postoperative 3 months
Secondary	Brain function	Resting functional magnetic resonance imaging (rs-fMRI) will measure brain structure and functional changes, including gray matter volume, gray matter thickness, functional connectivity.	Before surgery and at the postoperative 3 months