A Prospective Clinical Study Observed the Effects of Tubeless Anesthesia Method That Preserves Sp… (NCT07721038) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
China400 participantsStarted 2026-07-20
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of cognitive function biomarkers in the serum samples of 400 patients
Timeframe: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
2
Concentrations of HPA axis-related indicators in the serum samples of 400 patients
Timeframe: Before the start of the surgery (T1), at the end of the surgery (T2)
3
The concentrations of laboratory test indicators in the serum samples of 400 patients
Timeframe: Before the start of the surgery (T1), and on the first day after the surgery (T3)