Sedation Strategies for Diagnostic Bronchoscopy 2

Naval Military Medical University

Status: Unknown

Conditions: Sedation; Bronchoscopy

Treatments: Drug: Remifentanil; Drug: Dexmedetomidine; Drug: Propofol; Drug: Fentanyl; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03983889

SED-DFB2

Details and patient eligibility

About

Diagnostic bronchoscopy is an invasive procedure performed to diagnose respiratory diseases. But pain has been complained by most of the patients receiving such procedures. Sedation or anesthesia was required by both of the patients and bronchoscopists. Unfortunately, no consensus has been made upon the sedation strategies. Multiple sedation approaches have been applied, such as midazolam and fentanyl, remifentanil and propofol, dexmedetomidine and propofol. The present study was designed to compare these protocols in sedation for diagnostic bronchoscopy.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for flexible diagnostic bronchoscopy
• Adult patients aged 18 to 65 years
• American Society of Anesthesiologists (ASA) Physical Status Classification I-II
• BMI 18.5-25kg/m2
• Subjects provide informed consent

Exclusion criteria

• Severe airway obstruction
• Coagulation disorder
• Repeat bronchoscopy (more than 3 times)
• Severe liver and renal dysfunction
• Cardiovascular and cerebrovascular diseases
• Pregnancy
• Chronic opioid user
• Drug abusers or addicts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups

F

Experimental group

Description:

Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance

Treatment:

Drug: Midazolam

Drug: Fentanyl

DR

Experimental group

Description:

Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance

Treatment:

Drug: Midazolam

Drug: Dexmedetomidine

Drug: Remifentanil

DF

Experimental group

Description:

Sedated with intravenous midazolam (0.03mg/kg), dexmedetomidine (0.5-1μg/kg for induction+0.5-0.7μg/kg/h for maintenance) and fentanyl (1μg/kg) for induction and maintenance

Treatment:

Drug: Midazolam

Drug: Dexmedetomidine

Drug: Fentanyl

PR

Experimental group

Description:

Sedated with intravenous midazolam (0.03mg/kg), propofol (plasma concentration 1.0-2.0ng/ml) and remifentanil (plasma concentration 2.0-2.5ng/ml) for induction and maintenance

Treatment:

Drug: Propofol

Drug: Midazolam

Drug: Remifentanil