Sedation Strategies for Diagnostic Bronchoscopy 2

The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy

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.

Study Overview

• Status: Unknown
• Conditions: Sedation; Bronchoscopy
• Intervention / Treatment: Drug: Midazolam; Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Remifentanil; Drug: Propofol

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Faculty of Anesthesiology, Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F; Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance	Drug: Midazolam; Midazolam is used as a common medication for sedation in all groups.; Drug: Fentanyl; Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
Experimental: DR; 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	Drug: Midazolam; Midazolam is used as a common medication for sedation in all groups.; Drug: Dexmedetomidine; Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.; Drug: Remifentanil; Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
Experimental: DF; 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	Drug: Midazolam; Midazolam is used as a common medication for sedation in all groups.; Drug: Fentanyl; Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.; Drug: Dexmedetomidine; Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
Experimental: PR; 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	Drug: Midazolam; Midazolam is used as a common medication for sedation in all groups.; Drug: Remifentanil; Remifentanil is used for analgesia to prevent bronchoscopy induced cough.; Drug: Propofol; Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough score	Cough score across the procedure will be classified into 4 degree (1-4) as follows. 1 = none, 2 = one gag or cough only, 3 = >1 gag or cough, but acceptable conditions, 4 = unacceptable conditions	From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Duration of the recovery from sedation	After termination of the sedation medication, assessed up to 2 hours
Body movement	The numbers of the times of any body movement across the procedure	From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours
Satisfaction score of the patients and bronchoscopists	Satisfaction score of the patients and bronchoscopists regarding to the sedation quality measured by a 0-100 visual analogue scale (VAS). 100 refers to the highest satisfaction degree while 0 refers to the worst satisfaction degree. The scale score was determined by the subjective determination of the satisfaction on the sedation quality.	Across the procedure, assessed up to 2 hours
Amount of the rescue use of propofol	The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.	After sedation induction, assessed up to 2 hours
Prevalence of the side effects of respiratory and circulatory system	The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.	Across the sedation duration, assessed up to 2 hours

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shanghai Zhongshan Hospital; Ruijin Hospital; Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Anticipated): June 17, 2019
• Primary Completion (Anticipated): November 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; 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, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Remifentanil; Fentanyl; Midazolam; Propofol; Dexmedetomidine
• Other Study ID Numbers: SED-DFB2

Drug and device information, study documents

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