Clinical trial NCT06310785: Esketamine Anesthesia in Thoracic Surgery
Official title: Opioid-Free Anesthesia Utilizing Esketamine for Thoracoscopic Pulmonary Nodule Surgery: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Thoracic Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Esketamine group was induced with esketamine 0.5 mg/kg, propofol 2 mg/kg, and rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and esketamine 0.5 mg/kg/h. Anesthesia induction in the opioid group Sufentanil 0.5 ug/kg, propofol 2 mg/kg, rocuronium bromide 0.9 mg/kg. Anesthesia is maintained with propofol 5 mg/kg/h and remifentanil 1 ug/kg/h.

Detailed description: Before anesthesia induction, radial artery puncture and catheterization under local anesthesia for manometry, and intravenous pentethylquine hydrochloride 1 mg and dexamethasone 5 mg were given. Anesthesia-induced opioid group (group A) received 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 intravenous propofol 2 mg/kg and rocuronium bromide 0.9 mg/kg. After the onset of rocuronium bromide, the left double-lumen bronchial intubation was guided by a video laryngoscope, the correct position of the catheter was confirmed by bronchoscope, and the anesthesia machine was connected to the anesthesia machine for mechanical ventilation after fixation, with a tidal volume of 6 mL/kg (ideal body weight), a respiratory rate of 12\~18 breaths/min, and end-expiratory carbon dioxide partial pressure at 35\~40 mmHg.

Intraoperative anesthesia maintenance opioid group was injected with intravenous injection of propofol (5 mg/kg/h) and remifentanil (1 ug/kg/h), and esketamine group was pumped with propofol (5 mg/kg/h) and esketamine (0.5 mg/kg/h). After the lateral decubitus position is set up and the lateral paravertebral nerve block (T4, T6 levels 0.5% ropivacaine 10 ml each) is performed under ultrasound guidance, and the anesthesiologist is responsible for the complications and accidents that occur during the routine management of anesthesia. After the operation, they were given 200 mg of sugammadex sodium as an antagonistic residual muscle relaxant, and after being extubated awakely, they were sent to PACU for continued PCIA treatment and observation, and returned to the thoracic surgery ward for further treatment after reaching the discharge criteria.

Eligibility criteria: Inclusion Criteria:

1. ASA scores 1 \~ 2
2. Age \> 18 years and \< 70 years
3. Thoracoscopic segmentectomy or lobectomy is proposed under general anesthesia
4. Patient controlled intravenous analgesia was planned
5. Sign informed consent.

Exclusion Criteria:

1. BMI\>30 kg/m2 or \< 19 kg/m2;
2. preoperative use of opioids, acute and chronic pain or hyperalgesia;
3. Preoperative coronary atherosclerotic heart disease, significant ischemic heart disease, severe angina, heart failure, valvular disease or other heart disease;
4. severe hepatic and renal insufficiency before operation;
5. A history of mental illness or alcoholism;
6. A history of alcohol or drug abuse;
7. cranial pressure, intraocular pressure or suffering from glaucoma;
8. Poorly controlled or untreated hypertension;
9. Preeclampsia or eclampsia;
10. untreated and undertreated hyperthyroidism;
11. The Numerical Rating Scale (NRS) cannot be used.

Primary outcomes:
measure: Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation
timeFrame: During the operation, the patient was ventilated on one lung for 30 minutes
Secondary outcomes:
measure: Lung compliance during double lung ventilation during operation
timeFrame: 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
measure: Compliance of the ventilator-side lung during one-lung ventilation during operation
timeFrame: At the beginning of one-lung ventilation during operation; one-lung ventilation for 1 hour during the operation
measure: Blood pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Blood gas analysis results
timeFrame: 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
measure: Serum inflammatory factor levels
timeFrame: Before anesthesia induction;one-lung ventilation for 30 minutes during operation; one-lung ventilation for 1 hour during operation; 30 minutes after surgery
measure: cognitive function
timeFrame: The day before surgery;Day one after surgery;day three after surgery
measure: Postoperative nausea and vomiting
timeFrame: 6 hours postoperatively, 24 hours postoperatively, and 48 hours postoperatively
measure: Depression and anxiety
timeFrame: The day before surgery; Day two after surgery
measure: Postoperative pain
timeFrame: 6 hours postoperatively, 24 hours postoperatively, and 48 hours postoperatively
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: