Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location contact

Lan Lan, PHD

CONTACT

[email protected]

+8602083062566

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. 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)

    At time points T1, T2, and T3, 5 ml of peripheral venous blood was collected to test the biological indicators of postoperative cognitive function.

  2. 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)

    At the TI-T2 time point, 5 ml of peripheral venous blood was collected for the detection of HPA axis-related indicators.

  3. 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)

    Record the laboratory test indicators at time points T1 and T3

Secondary outcomes

  1. Anesthesia Record Form

    Time frame: at the end of the surgery (T2)

    Record the vital signs at the T2 time point

  2. Case information system collection

    Time frame: Before the start of the surgery (T1), and on the first day after the surgery (T3)

    Record the pulmonary function, chest X-ray or chest CT at time points T1 and T3

  3. Anesthesia Record Form

    Time frame: During the operation

    Record the intraoperative conditions

  4. Postoperative follow-up records

    Time frame: through study completion, an average of 1 year

    Record the time of chest tube removal after surgery

  5. Postoperative follow-up records

    Time frame: through study completion, an average of 1 year

    the usage of postoperative analgesic drugs

  6. Postoperative follow-up records

    Time frame: through study completion, an average of 1 year

    the postoperative hospital stay

  7. Postoperative follow-up records

    Time frame: through study completion, an average of 1 year

    the total hospitalization cost

Other outcomes

  1. Postoperative follow-up records

    Time frame: through study completion, an average of 1 year

    Record the occurrence of adverse events during the perioperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Fengfa Yang, BS

CONTACT

[email protected]

+8602083062566

Lan Lan, PHD

CONTACT

[email protected]

+8602083062566

Sponsors and collaborators

Lead sponsor

Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.