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

NCT06199011 | Unknown

• 1 other identifier: EDSOP
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Postoperative anxiety

  In 3 months after surgery

• Hamilton Anxiety Rating Scale

  Before surgery and at the postoperative 3 months

• Cognition

  Before surgery and at the postoperative 3 months

• The incidence of Postoperative nausea and vomiting

  At 0-24 hours after surgery

• Postoperative depressive symptoms

  In 3 months after surgery

Study Arms (2)

Control Group: Standardized general anesthesia

ACTIVE COMPARATOR

The control group is standard of opioid anesthesia including reminfentanil and sufentanil. In addition to dexmedetomidine and transverse abdominal plane block, general anesthesia induction will be induced performed with sufentanil (0.5 μg kg-1), propofol (1.5 mg kg-1), and rocuronium (1 mg kg-1). General anesthesia was maintained with a continuous infusion of remifentanil (5-15 μg kg-1 h-1), cisatracurium (0.1-0.2 mg kg-1 h-1), dexmedetomidine (0.4 μg kg-1 h-1), and sevoflurane exposure guided by bispectral index. Dexmedetomidine administration and sevoflurane inhalation will be completed at 20 minutes before surgery finish. Propofol and remifentanil will be continuously infused till the end of surgery.

Drug: Opioid

Intervention Group: A standardized non-opioid anesthesia

EXPERIMENTAL

Dexmedetomidine (0.5μg kg-1) and esketamine (0.25mg kg-1) was intravenously infused to provide sedation for the bilateral transverse abdominal plane block (0.33% ropivacaine and dexmedetomidine 1μg kg-1). General anesthesia was then induced with esketamine (0.25 mg kg-1 h-1), propofol (1.5 mg kg-1), and rocuronium (1 mg kg-1). Following endotracheal intubation, GA was maintained with a continuous infusion of esketamine (0.25 mg kg-1 h-1), cisatracurium (0.1-0.2 mg kg-1 h-1), dexmedetomidine (0.4 μg kg-1 h-1), and sevoflurane guided by bispectral index. The infusions of esketamine and dexmedetomidine, as well as sevoflurane inhalation will be finished at 20 minutes before surgery completion. Propofol will be continuously infused to maintain appropriate bispectral index.

Drug: Esketamine hydrochloride

Interventions

Esketamine hydrochloride DRUG

A standardized non-opioid anesthesia will be achieved by using continuous intraoperative infusion of esketamine.

Intervention Group: A standardized non-opioid anesthesia

Opioid DRUG

A standardized opioid anesthesia will be achieved by using continuous intraoperative infusion of opioids.

Control Group: Standardized general anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

MeSH Terms

Conditions

Depression

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Chunxia Huang, PhD

CONTACT

+8613500512159; huangchunxia@ahmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share