The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

NCT06116955 | Completed DMC

• 1 other identifier: QYFYEC2023-111
• Study Type: observational
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchoscopy

Keywords

Propofol; Balanced propofol sedation; Remazolam; Bronchoscopy

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  During bronchoscopy.

• Patient's recovery time

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

  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.

  The end of bronchoscopy (up to 2 hours).

Secondary Outcomes (10)

• Induction time

  Before bronchoscopy.

• Drug dosage

  Before bronchoscopy and during bronchoscopy.

• Additional frequency of propofol during bronchoscopy

  During bronchoscopy.

• Additional frequency of 2% lidocaine during bronchoscopy

  During bronchoscopy.

• Additional dosage of 2% lidocaine during bronchoscopy

  During bronchoscopy.

Study Arms (4)

S-M group

Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.

Drug: Midazolam and sufentanil

S-M-P group

Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.

Drug: Midazolam, sufentanil and propofol

S-R group

Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.

Drug: Remazolam and sufentanil.

S-R-P group

Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.

Drug: Remazolam, sufentanil and propofol

Interventions

Midazolam and sufentanil DRUG

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

S-M group

Midazolam, sufentanil and propofol DRUG

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

S-M-P group

Remazolam and sufentanil. DRUG

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

S-R group

Remazolam, sufentanil and propofol DRUG

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

S-R-P group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population undergoing bronchoscopy examination at Qingdao University Affiliated Hospital from December 2023 to January 2014.

You may qualify if:

• American Society of Anesthesiologists classes I-IV ;
• 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;
• Normal communication skills and able to cooperate in completing this study;
• Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form".

You may not qualify if:

• Patients with contraindications or allergies to anesthesia;
• Individuals with a history of alcoholism or drug abuse;
• Patients with contraindications for puncture of the cricoid membrane;
• Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels;
• Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies;
• Patients who require laryngeal mask or tracheal intubation for assisted ventilation during the examination process;
• Patients undergoing rigid bronchoscopy treatment;
• Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Affiliated Hospital of Qingdao University

Shandong, Qingdao, China

Location

MeSH Terms

Interventions

Midazolam; Sufentanil; Propofol

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 3, 2023
• Study Start: September 21, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)