Esketamine Anesthesia in Thoracic Surgery

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310785
• Other study ID #: TJ-IRB20231191
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Hui Xu, MD
• Phone: 13971001596
• Email: huixu[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Thoracic Surgery

Intervention

Drug:
• Esketamine
The esketamine group used esketamine as an analgesic during induction and maintenance of anesthesia.
• Sufentanil
In the opioid group, sufentanil was used as an analgesic during anesthesia induction and remifentanil was used as an analgesic during anesthesia maintenance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Xu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic compliance of the ventilator-side lung during 30 minutes of one-lung ventilation during operation	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	During the operation, the patient was ventilated on one lung for 30 minutes
Secondary	Lung compliance during double lung ventilation during operation	The respiratory parameters displayed on the anesthesia ventilator screen during the operation were recorded, and the lung compliance during double-lung ventilation was calculated by the formula: lung compliance = tidal volume/(plateau pressure - positive end-expiratory pressure)	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
Secondary	Compliance of the ventilator-side lung during one-lung ventilation during operation	The respiratory parameters displayed on the anesthesia ventilator screen during the operation were recorded. The formula: lung compliance = tidal volume/(plateau pressure - positive end-expiratory pressure) was used to calculate the compliance of the ventilate lung during single lung ventilation	At the beginning of one-lung ventilation during operation; one-lung ventilation for 1 hour during the operation
Secondary	Blood pressure	Patient invasive arterial 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
Secondary	Heart rate	Patient 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
Secondary	Blood gas analysis results	The patient's arterial blood was collected, and the blood gas analyzer was used to determine the human blood H+ concentration and the gas dissolved in the blood (mainly CO2 and O2) to understand the human respiratory function and acid-base balance. Blood gas analysis results include: PaO2(mmHg), PaCO2(mmHg)	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
Secondary	Serum inflammatory factor levels	Collect the patient's arterial blood, obtain the upper serum through centrifuge, and return the obtained serum to a third party for detection the levels of inflammatory factors in the serum,such as interleukin-8 (IL?8,pg/mL), interleukin-6 (IL?6,pg/mL) concentration, TNF-a(pg/mL) and so on	Before anesthesia induction;one-lung ventilation for 30 minutes during operation; one-lung ventilation for 1 hour during operation; 30 minutes after surgery
Secondary	cognitive function	"Mini-mental State Examination, MMS" was used to evaluate the cognitive function of the patients. The total score of the scale was 30, with the lowest score being 0 and the highest 30. A normal person's MMSE score is usually between 27 and 30 points. If the score is lower than 27, it is necessary to be alert to the existence of cognitive impairment. At the same time, according to different levels of education, the classification criteria are also different. For example, illiteracy below 17 points, primary school education below 20 points, secondary school education below 22 points, college education below 23 points, are considered to have cognitive impairment.	The day before surgery;Day one after surgery;day three after surgery
Secondary	Postoperative nausea and vomiting	Postoperative nausea and vomiting were evaluated using the "Nausea and Vomiting Numerical Rating Scale", the lowest score being 0 and the highest 10, 0 was no nausea; 1-3 is classified as mild nausea; 4-6 classified as moderate nausea; In addition, regardless of the degree of nausea, patients should also record whether they are accompanied by vomiting. If they are accompanied by vomiting, select Yes; Not accompanied by vomiting Select No.	6 hours postoperatively, 24 hours postoperatively, and 48 hours postoperatively
Secondary	Depression and anxiety	The Hospital Anxiety and Depression Scale (HAD) was used to assess the degree of anxiety and depression symptoms. The lowest score is 0 and the highest score is 42. A score of 0-7 is considered normal, a score of 8-10 is suspected of anxiety and depression, and a score of 11-21 is certain of anxiety and depression. In the evaluation, =8 points were positive	The day before surgery; Day two after surgery
Secondary	Postoperative pain	The patients' postoperative pain was evaluated using the "Pain Numerical Rating Scale", the lowest score was 0, the highest score was 10, 0 indicates no pain; A 10 is the worst pain imaginable. A score of 1 to 3 indicates mild pain that does not affect sleep; A score of 4 to 6 indicates moderate pain and disturbed sleep. A score of 7 to 10 indicates severe pain that severely interferes with sleep	6 hours postoperatively, 24 hours postoperatively, and 48 hours postoperatively