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

ConditionBrain Health
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorGuangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients who underwent elective non-anatomic partial lung resection surgery at the First Affiliated Hospital of Guangzhou Medical University

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: tubeless group
Group B: double-lumen bronchial intubation group

Trial outcomes

Primary outcomes

1

Concentration of cognitive function biomarkers in the serum samples of 400 patients

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

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)
2

Concentrations of HPA axis-related indicators in the serum samples of 400 patients

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

Time frame
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

Record the laboratory test indicators at time points T1 and T3

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

Secondary outcomes

1

Anesthesia Record Form

Record the vital signs at the T2 time point

Time frame
at the end of the surgery (T2)
2

Case information system collection

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

Time frame
Before the start of the surgery (T1), and on the first day after the surgery (T3)
3

Anesthesia Record Form

Record the intraoperative conditions

Time frame
During the operation
4

Postoperative follow-up records

Record the time of chest tube removal after surgery

Time frame
through study completion, an average of 1 year

Other outcomes

1

Postoperative follow-up records

Record the occurrence of adverse events during the perioperative period

Time frame
through study completion, an average of 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: