Esketamine Anesthesia in Thoracic Surgery

NCT ID: NCT06310785

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-04
• Study Completion Date: 2024-10-31

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.

Conditions

General Anesthesia; Thoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Esketamine group

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.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

The esketamine group used esketamine as an analgesic during induction and maintenance of anesthesia.

opioid group

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.

Group Type: ACTIVE_COMPARATOR

Sufentanil

Intervention Type: DRUG

In the opioid group, sufentanil was used as an analgesic during anesthesia induction and remifentanil was used as an analgesic during anesthesia maintenance.

Interventions

Esketamine

The esketamine group used esketamine as an analgesic during induction and maintenance of anesthesia.

Intervention Type: DRUG

Sufentanil

In the opioid group, sufentanil was used as an analgesic during anesthesia induction and remifentanil was used as an analgesic during anesthesia maintenance.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui Xu

OTHER

Sponsor Role: lead

Responsible Party

Hui Xu

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

TJ-IRB20231191

Identifier Type: -

Identifier Source: org_study_id