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Not yet recruiting NCT07721038

A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Spontaneous Breathing and the Double-lumen Bronchial Intubation on the Brain Health During the Perioperative Period

— Observational Brain Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Brain Health. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health

Overview

This project conducts a prospective cohort study. By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.

Primary outcome measures

  • Concentration of cognitive function biomarkers in the serum samples of 400 patients [Time frame: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)]
  • Concentrations of HPA axis-related indicators in the serum samples of 400 patients [Time frame: Before the start of the surgery (T1), at the end of the surgery (T2)]
  • The concentrations of laboratory test indicators in the serum samples of 400 patients [Time frame: Before the start of the surgery (T1), and on the first day after the surgery (T3)]
Secondary outcome measures (7)
  • Anesthesia Record Form [Time frame: at the end of the surgery (T2)]
  • Case information system collection [Time frame: Before the start of the surgery (T1), and on the first day after the surgery (T3)]
  • Anesthesia Record Form [Time frame: During the operation]
  • Postoperative follow-up records [Time frame: through study completion, an average of 1 year]
  • Postoperative follow-up records [Time frame: through study completion, an average of 1 year]
  • Postoperative follow-up records [Time frame: through study completion, an average of 1 year]
  • Postoperative follow-up records [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

  • Patient age: 18 - 75 years old
  • Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
  • Body Mass Index (BMI) < 30 kg/m2
  • Intraoperative blood loss less than 300 ml
  • No severe cardiac or pulmonary dysfunction \[first-second forced vital capacity (FEV1%) predicted value\] > 50%, ejection fraction (EF) > 50%
  • No contraindications related to paravertebral nerve block and intercostal nerve block
  • Able to sign the informed consent form and possess communication, reading and writing abilities
  • Postoperative hospital stay of at least one day
  • No preoperative sleep disorders, no cognitive dysfunction (PSQI ≤ 10 points, PCS ≤ 38 points, MMSE > 27 points)

Exclusion criteria

  • Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
  • History of opioid abuse
  • Patients who were admitted to the ICU after surgery
  • Have severe cardiovascular, respiratory diseases
  • Experienced critical rescue during or after the surgery
  • Complicated with coagulation dysfunction, severe hypoxia or hypercapnia, or liver and kidney dysfunction
  • Difficult airway management
  • Changed anesthetic agent or surgical plan
  • Severe lacunar cerebral infarction, ischemic stroke or other neurological diseases
  • Changed anesthetic agent or surgical plan during the surgery;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • the First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07721038 · ES-2025-216-02 · GMUCR2025-02011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗