The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

Sponsor

The Affiliated Hospital of Qingdao University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06116955

Collaborator

(none)

210

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the feasibility of using balanced propofol sedation to titrate to moderate to depth sedation level for bronchoscopy. And screen out the optimal balanced propofol sedation compatibility plan. What's more, by comparing the changes in emotional indicators before and after sedation to evaluate whether Esketamine can improve the anxiety/depression status of patients undergoing bronchoscopy.

Condition or Disease	Intervention/Treatment	Phase
Bronchoscopy	Drug: Midazolam and sufentanil Drug: Midazolam, sufentanil and propofol Drug: Esketamine, sufentanil and propofol Drug: Remazolam, sufentanil and propofol Drug: Remazolam, esketamine 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 Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
S-M group Anesthesiologists Choose midazolam combining with sufentanil to titrate to moderate to deep sedation for bronchoscopy.	Drug: Midazolam and sufentanil Anesthesiologist administers 0.05mg/kg of midazolam and 0.1ug/kg of sufentanil, and then titrates midazolam at a rate of 1 mg/dose to moderate to deep sedation levels. The MOAA/S score is evaluated every 3 minutes. If the patient's sedation score is greater than 3 points, midazolam should be injected 0.5mg/time until the preset sedation depth.
S-M-P group Anesthesiologists choose midazolam and sufentanil combining with low-dose propofol to titrate to moderate to deep sedation for bronchoscopy.	Drug: Midazolam, sufentanil and propofol Anesthesiologist administers 0.05mg/kg of midazolam and 0.1ug/kg of sufentanil, and then titrates propofol at a rate of 5-10mg/dose to moderate to deep sedation levels. After induction, anesthesiologist starts the injection pump and continued to pump physiological saline at a rate of 0.1 ml/(kg * h). The MOAA/S score is evaluated every 3 minutes. If the patient's sedation score is greater than 3 points, propofol should be injected 5-10mg/time until the preset sedation depth.
S-E-P group Anesthesiologists choose esketamine and sufentanil combining with low-dose propofol to titrate to moderate to deep sedation for bronchoscopy.	Drug: Esketamine, sufentanil and propofol Anesthesiologist administers 0.15mg/kg of esketamine and 0.1ug/kg of sufentanil, and then titrates propofol at a rate of 5-10mg/dose to moderate to deep sedation levels. After induction, anesthesiologist starts the injection pump and continued to pump physiological saline at a rate of 0.1 ml/(kg * h). The MOAA/S score is evaluated every 3 minutes. If the patient's sedation score is greater than 3 points, propofol should be injected 5-10mg/time until the preset sedation depth.
S-R-P group Anesthesiologists choose remazolam and sufentanil combining with low-dose propofol to titrate to moderate to deep sedation for bronchoscopy.	Drug: Remazolam, sufentanil and propofol Anesthesiologist administers 0.05mg/kg of remazolam and 0.1ug/kg of sufentanil, and then titrates propofol at a rate of 5-10mg/dose to moderate to deep sedation levels. After induction, anesthesiologist starts the injection pump and continued to pump 1mg/ml of remimazolam at a rate of 0.1 ml/(kg * h). The MOAA/S score is evaluated every 3 minutes. If the patient's sedation score is greater than 3 points, propofol should be injected 5-10mg/time until the preset sedation depth.
E-R-P group Anesthesiologists choose remazolam and esketamine combining with low-dose propofol to titrate to moderate to deep sedation for bronchoscopy.	Drug: Remazolam, esketamine and propofol Anesthesiologist administers 0.05mg/kg of remazolam and 0.15mg/kg of esketamine, and then titrates propofol at a rate of 5-10mg/dose to moderate to deep sedation levels. After induction, anesthesiologist starts the injection pump and continued to pump 1mg/ml of remimazolam at a rate of 0.1 ml/(kg * h). The MOAA/S score is evaluated every 3 minutes. If the patient's sedation score is greater than 3 points, propofol should be injected 5-10mg/time until the preset sedation depth.

Outcome Measures

Primary Outcome Measures

Patient satisfaction [During bronchoscopy.]
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).
Clinical satisfaction [During bronchoscopy.]
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).
Patient's recovery time [The end of bronchoscopy (up to 2 hours).]
The investigator needs to record the wake-up time of patients after the end of bronchoscopy.
Patient's departure time [The end of bronchoscopy (up to 2 hours).]
The investigator needs to record the patient's departure time after the end of bronchoscopy.

Secondary Outcome Measures

Induction time [Before bronchoscopy.]
Time from administering sedative and analgesic drugs to titration with propofol until MOAA/S 2-3 points.
Drug dosage [Before bronchoscopy and during bronchoscopy.]
Induced, maintenance and total dose of midazolam, propofol.
Additional frequency of body movements/coughing during bronchoscopy [During bronchoscopy.]
Additional frequency of propofol and 2% lidocaine during bronchoscopy.
Additional dosage of body movements/coughing during bronchoscopy [During bronchoscopy.]
Additional dosage of propofol and 2% lidocaine during bronchoscopy.
Patient response score during bronchoscopy [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).
Adverse reactions during bronchoscopy [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.
Adverse reactions after fully awake [The end of bronchoscopy (up to 2 hours).]
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).
Patient's anxiety/depression state [Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists classes III and IV I-III;
Patients who only undergo painless bronchoscopy, including bronchoscopic biopsy (bronchoscopic lesion biopsy, bronchial mucosal biopsy, bronchoscopic transmural lung biopsy, bronchoscopic needle aspiration biopsy) and bronchoalveolar lavage;
SpO2 ≥ 90% under air suction;
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".

Exclusion Criteria:

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 underwent painless bronchoscopy in our hospital within one month prior to the start of this study;
During this study, patients who underwent repeated painless bronchoscopy examinations;
Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".