The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

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.

Study Overview

• Status: Completed
• Conditions: Bronchoscopy
• Intervention / Treatment: Drug: Midazolam and sufentanil; Drug: Midazolam, sufentanil and propofol; Drug: Remazolam and sufentanil.; Drug: Remazolam, sufentanil and propofol

Detailed Description

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 (Actual): 424

Contacts and Locations

Study Locations

• China
  • Qingdao
    • Shandong, Qingdao, China
      • Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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".

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
S-M group; Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.	Drug: Midazolam and sufentanil; Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with midazolam combined with sufentani.
S-M-P group; Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.	Drug: Midazolam, sufentanil and propofol; Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with midazolam and sufentani combined with propofol.
S-R group; Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.	Drug: Remazolam and sufentanil.; Patients undergoing bronchoscopic diagnosis and treatment under moderate sedation with remazolam combined with sufentani.
S-R-P group; Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.	Drug: Remazolam, sufentanil and propofol; Patients undergoing bronchoscopic diagnosis and treatment under deep sedation with remazolam and sufentani combined with propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction time	Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.	Before bronchoscopy.
Drug dosage	Induced, maintenance and total dose of midazolam, propofol.	Before bronchoscopy and during bronchoscopy.
Patient response score during bronchoscopy	Researcher used the Behavioral Pain Scale for non intubated patients (BPS-NI) to assess their response scores. The tool consists of 3 behavioral domains: facial expressions, movements, and vocalization. The total BPS-IN value can range from 3 (no pain) to 12 (most pain).	During bronchoscopy.
Adverse reactions during bronchoscopy	Record the number of occurrences of hypotension, hypertension, tachycardia, bradycardia, arrhythmias, hypoxemia, apnea, coughing (no wheezing during continuous coughing, considered as one coughing), and physical activity (non directive limb activity) during bronchoscopy. After fully awake, researcher 2 used the VAS score for adverse reactions during the resuscitation process, such as dizziness, pain, nausea, breathing difficulties, etc.	During bronchoscopy
Adverse reactions after fully awake	After fully awake, researcher used the VAS score for adverse reactions during the resuscitation process, such as dizziness, pain, nausea, breathing difficulties, etc. The score from 0 (no uncomfortable) to 10 (extremely uncomfortable).	The end of bronchoscopy (up to 2 hours).
Patient's anxiety/depression state	Researcher used the Patient Health Questionnaire-8 (PHQ-8) to assess Patient's anxiety/depression state. The total score range of PHQ-8 is 0-24. No depressive symptoms on a score of 0-4, mild on a score of 5-9, moderate on a score of 10-14, and severe on a score of 15 or above.	Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.
Additional frequency of propofol during bronchoscopy	Additional frequency of propofol during bronchoscopy.	During bronchoscopy.
Additional frequency of 2% lidocaine during bronchoscopy	Additional frequency of 2% lidocaine during bronchoscopy.	During bronchoscopy.
Additional dosage of 2% lidocaine during bronchoscopy	Additional dosage of 2% lidocaine during bronchoscopy.	During bronchoscopy.
Additional dosage of propofol during bronchoscopy	Additional dosage of propofol during bronchoscopy.	During bronchoscopy.

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Bronchoscopy; Propofol; Balanced propofol sedation; Remazolam
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Propofol; Sufentanil; Dsuvia
• Other Study ID Numbers: QYFYEC2023-111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No