Sedation Strategies for Diagnostic Bronchoscopy

Naval Military Medical University

Status: Terminated

Conditions: Sedation; Bronchoscopy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03406533

SED-DFB

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: 28 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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28 participants in 4 patient groups

Group F

Experimental group

Description:

Sedated with midazolam and fentanyl

Treatment:

Drug: Midazolam

Drug: Fentanyl

Group DR

Experimental group

Description:

Sedated with midazolam, dexmedetomidine and remifentanil

Treatment:

Drug: Remifentanil

Drug: Midazolam

Drug: Dexmedetomidine

Group DF

Experimental group

Description:

Sedated with midazolam, dexmedetomidine and fentanyl

Treatment:

Drug: Midazolam

Drug: Fentanyl

Drug: Dexmedetomidine

Group PR

Experimental group

Description:

Sedated with midazolam, propofol and remifentanil

Treatment:

Drug: Remifentanil

Drug: Propofol

Drug: Midazolam