Esketamine Anesthesia in Thoracic Surgery

NCT06310785 | Completed

• 1 other identifier: TJ-IRB20231191
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Anesthesia; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Static Lung Compliance

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

  During the operation (at 30 minutes of one-lung ventilation).

Secondary Outcomes (10)

• Static lung compliance during operation

  At the beginning of double lung ventilation, start of one-lung ventilation, and end of surgery.

• Perioperative pulmonary function

  The day before surgery, one day after surgery, two days after surgery, three days after surgery

• Blood pressure

  At admission, immediately before intubation, immediately after intubation, at the beginning of double lung ventilation, start of one-lung ventilation, 30 min after the start of one-lung ventilation, end of surgery, and on transfer from the PACU.

• Heart rate

  At admission, immediately before intubation, immediately after intubation, at the beginning of double lung ventilation, start of one-lung ventilation, 30 min after the start of one-lung ventilation, end of surgery, and on transfer from the PACU.

• Blood gas analysis results

  At admission, at the beginning of double lung ventilation, one-lung ventilation for 30 minutes, end of surgery, and transfer from the PACU.

Study Arms (2)

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

Drug: Esketamine

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

Drug: Sufentanil

Interventions

Esketamine DRUG

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

Esketamine group

Sufentanil DRUG

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

opioid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Hui Xu: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Esketamine; Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither the patients who participated in the trial nor the analysis of the results of the study were aware of the experimental group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 15, 2024
• Study Start: February 4, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)