Effect of Intraoperative Esketamine Infusion on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Hamilton depression Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI≥40kg/m2 or BMI>35 kg/m2 with an existing comorbidity
- •scheduled for selective LSG
- •American Society of Anesthesiologists physical status I-III
- •with informed consent
排除标准
- •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
研究组 & 干预措施
Control Group: Standardized general anesthesia
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.
干预措施: Opioid (Drug)
Intervention Group: A standardized non-opioid anesthesia
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.
干预措施: Esketamine hydrochloride (Drug)
结局指标
主要结局
Hamilton depression Rating Scale
时间窗: 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.
次要结局
- Postoperative anxiety(In 3 months after surgery)
- Hamilton Anxiety Rating Scale(Before surgery and at the postoperative 3 months)
- Postoperative pain(At 0-24 hours after surgery)
- Consumption of anesthetics(During the surgery)
- Length of anesthesia(At the end of anesthesia)
- QoR-15(At 24 hours after surgery)
- Adverse event rate(During postoperative 3 months)
- BMI(Before surgery and at the postoperative 3 months)
- Time to the first rescue antiemetics(At 0-24 hours after surgery)
- Length of surgery(At the end of surgery)
- Pittsburgh Sleep Quality Index(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)
- Time to the first rescue analgesics(At 0-24 hours after surgery)
- Gastrointestinal Symptom Rating Scale(Before surgery and at the postoperative 3 months)
- Quality of health and functional status(Before surgery and at the postoperative 3 months)
- Brain function(Before surgery and at the postoperative 3 months)
研究者
Chunxia Huang
Associate Professor
The Second Hospital of Anhui Medical University