The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

The Affiliated Hospital of Qingdao University424 enrolled

Overview

The purpose of this study is to investigate the feasibility of using balanced propofol sedation for bronchoscopy. And screen out the optimal balanced propofol sedation compatibility plan.

Balanced propofol sedation (BPS) is a technique proposed and developed by gastroenterologists. In recent years, multiple studies have confirmed that the use of BPS in gastrointestinal endoscopy can not only ensure patient comfort, but also reduce the incidence of respiratory and circulatory suppression. Moreover, the postoperative recovery time is short. Even for non-anesthesiologists applying BPS in gastrointestinal endoscopy , it has high safety. Compared with gastrointestinal endoscopy, bronchoscopy occupies the respiratory tract and most patients have respiratory system diseases. Therefore, it is more necessary for strict respiratory management and control of patient sedation depth. Traditional midazolam combined with opioid drugs or propofol monosedation cannot effectively meet clinical needs. The excellent sedative and analgesic effects of BPS, as well as its maintenance of respiratory and circulatory functions, make it theoretically very suitable for application in bronchoscopy. However, there is currently a lack of evidence to support the application of BPS in bronchoscopy.

Study Type

OBSERVATIONAL

Enrollment

424

Conditions

Bronchoscopy

Interventions

Midazolam and sufentanilDRUG

Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.

Midazolam, sufentanil and propofolDRUG

Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.

Remazolam and sufentanil.DRUG

Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. American Society of Anesthesiologists classes I-IV ; 2. Patients undergo painless bronchoscopy, including bronchoscopic biopsy (bronchoscopic lesion biopsy, bronchial mucosal biopsy, bronchoscopic transmural lung biopsy, bronchoscopic needle aspiration biopsy) ,bronchoalveolar lavage and bronchoscopic treatment; 3. Normal communication skills and able to cooperate in completing this study; 4. Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form". Exclusion Criteria: 1. Patients with contraindications or allergies to anesthesia; 2. Individuals with a history of alcoholism or drug abuse; 3. Patients with contraindications for puncture of the cricoid membrane; 4. Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels; 5. Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies; 6. Patients who require laryngeal mask or tracheal intubation for assisted ventilation during the examination process; 7. Patients undergoing rigid bronchoscopy treatment; 8. Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".

Locations (1)

Affiliated Hospital of Qingdao University

Shandong, Qingdao, China

Outcomes

Primary Outcomes

Patient satisfaction

The investigator needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted bronchoscopy. The score from 0 (extremely dissatisfied) to 10 (extremely satisfied).

Time frame: During bronchoscopy.

Clinical satisfaction

The investigator needs to use VAS scores to evaluate satisfaction about doctors and nurses when they carry out the operation. The score from 0 (extremely dissatisfied) to 10 (extremely satisfied).

Time frame: During bronchoscopy.

Patient's recovery time

The investigator needs to record the wake-up time of patients after the end of bronchoscopy.

Time frame: The end of bronchoscopy (up to 2 hours).

Patient's departure time

The investigator needs to record the patient's departure time after the end of bronchoscopy.

Time frame: The end of bronchoscopy (up to 2 hours).

Secondary Outcomes

Induction time

Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.

Time frame: Before bronchoscopy.

Drug dosage

Induced, maintenance and total dose of midazolam, propofol.

Time frame: Before bronchoscopy and during bronchoscopy.

Additional frequency of propofol during bronchoscopy

Additional frequency of propofol during bronchoscopy.

Time frame: During bronchoscopy.

Data from ClinicalTrials.gov

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