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临床试验/NCT06310785
NCT06310785已完成不适用

Opioid-Free Anesthesia Utilizing Esketamine for Thoracoscopic Pulmonary Nodule Surgery: A Randomized Controlled Clinical Trial

Hui Xu1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年2月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation

研究概览

简要总结

Patients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Patients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/ kg/h and remifentanil 0.1 ug/kg/min.

详细描述

Before anesthesia induction, radial artery puncture and catheterization under local anesthesia for manometry, and intravenous dexmedetomidine (1 µg/kg) infused over 15 minutes, followed by penehyclidine hydrochloride (0.01mg/kg), palonosetron (0.075 mg), dexamethasone (5 mg). Anesthesia-induced in the opioid group (group A) was intravenous sufentanil 0.5 ug/kg, and esketamine group (group E) received intravenous esketamine 0.5 mg/kg. Subsequently, both groups were sequentially injected with propofol 2 mg/kg and rocuronium 0.9 mg/kg. After the onset of rocuronium, the left-sided double-lumen endotracheal tube was guided by a video laryngoscope, the correct position of the tube was confirmed by bronchoscope, and the anesthesia machine was connected to the tube for mechanical ventilation after fixation, with a tidal volume of 6-8 mL/kg (ideal body weight), a respiratory rate of 10~18 breaths/min, and end-expiratory carbon dioxide partial pressure at 35~45 mmHg (4.7-6.0 kPa).

Intraoperative anesthesia maintenance in the opioid group was pumped with propofol (5 mg/ kg/h) and remifentanil (0.1 ug/kg/h), and esketamine group was pumped with propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h). Rocuronium was administered as needed in intermittent boluses of 0.3 mg/kg intraoperatively. After the lateral decubitus position is set up and the paravertebral block (T4 and T6 levels, 0.5% ropivacaine, 10 ml each) was performed under ultrasound guidance, supplemented by 0.75% ropivacaine infiltration at the surgical site upon skin closure. At the completion of the surgery, patients were given 200 mg sugammadex sodium as an antagonistic residual muscle relaxant. They were transferred to the post-anesthesia care unit (PACU) after tracheal extubation and full recovery of consciousness, and returned to the thoracic surgery ward for further treatment after reaching the discharge criteria of PACU. Postoperative analgesia was provided without patient-controlled intravenous analgesia (PCIA). We employed a modified Brice questionnaire to assess the occurrence of intraoperative awareness. The confusion assessment method (CAM) was used to assess postoperative delirium (POD). Rescue analgesia with intravenous flurbiprofen axetil (50 mg) was administered when NRS scores reached ≥4. Rescue antiemetic therapy (intravenous palonosetron 0.075 mg) was provided for postoperative nausea and vomiting (PONV) scores reached ≥4.

Update note (2026-01-04): The record was updated to correct terminology/wording errors (e.g., static vs dynamic compliance; increased intracranial pressure vs intracranial pressure) and to clarify that PCIA was not used. Meanwhlie, a more detailed account that specifies the anesthetic management protocol with greater precision was provided. One prespecified secondary outcome (inflammatory biomarkers) was not collected; therefore, no data are available for that outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Neither the patients who participated in the trial nor the analysis of the results of the study were aware of the experimental group

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I-II
  • age 18-70 years
  • thoracoscopic segmentectomy or lobectomy is proposed under general anesthesia due to pulmonary nodule
  • informed consent was obtained

排除标准

  • (1) body mass index ˃30 kg/m2 or ˂ 19 kg/m2 (2) preoperative use of opioids, acute and chronic pain or hyperalgesia (3) significant ischemic heart disease, including preoperative coronary artery disease, severe angina, heart failure, or structural heart disease (e.g., significant valvular disease) (4) severe hepatic and renal failure before operation (5) history of mental illness or alcoholism (6) history of alcohol or drug abuse (7) increased intracranial pressure, elevated intraocular pressure, or a diagnosis of glaucoma (8) poorly controlled or untreated hypertension (9) preeclampsia or eclampsia (10) untreated and undertreated hyperthyroidism (11) inability to complete the required rating scales

研究组 & 干预措施

Esketamine group

Experimental

Patients in the esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h

干预措施: Esketamine (Drug)

opioid group

Active Comparator

Patients in the opioid group was induced with sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 0.1 ug/kg/min

干预措施: Sufentanil (Drug)

结局指标

主要结局

Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation

时间窗: During the operation, the patient was ventilated on one lung for 30 minutes

The respiratory parameters displayed on the anesthesia ventilator screen during 30 minutes of one-lung ventilation during operation were recorded. The formula: lung compliance = tidal volume/platform pressure (Pplat) - positive end expiratory pressure (PEEP) was used to calculate the compliance of the ventilate lung during 30 minutes of one-lung ventilation during operation

次要结局

  • Heart rate(BBefore surgery; during operation(Start of double lung ventilation、starting one-lung ventilation、one-lung ventilation for 30 minutes 、one-lung ventilation for 1 hour 、resume double lung ventilation; At the end of the operation; 30 minutes after operation)
  • Lung compliance during double lung ventilation during operation(At the beginning of double lung ventilation during operation; During the operation, the return from one-lung ventilation to double lung ventilation; At the end of the operation)
  • Serum inflammatory factor levels(Before anesthesia induction;one-lung ventilation for 30 minutes during operation; one-lung ventilation for 1 hour during operation; 30 minutes after surgery)
  • Compliance of the ventilator-side lung during one-lung ventilation during operation(At the beginning of one-lung ventilation during operation; one-lung ventilation for 1 hour during the operation)
  • Postoperative pain(6 hours postoperatively, 24 hours postoperatively, and 48 hours postoperatively)
  • Blood pressure(Before surgery; during operation(Start of double lung ventilation、starting one-lung ventilation、one-lung ventilation for 30 minutes 、one-lung ventilation for 1 hour 、resume double lung ventilation; At the end of the operation; 30 minutes after operation)
  • Blood gas analysis results(Before anesthesia induction; Double lung ventilation during operation;one-lung ventilation for 30 minutes during operation; one-lung ventilation for 1 hour during operation; At the end of the operation; 30 minutes after surgery)
  • cognitive function(The day before surgery;Day one after surgery;day three after surgery)
  • Postoperative nausea and vomiting(6 hours postoperatively, 24 hours postoperatively, and 48 hours postoperatively)
  • Depression and anxiety(The day before surgery; Day two after surgery)

研究者

发起方
Hui Xu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hui Xu

professor

Tongji Hospital

研究点 (1)

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