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出境医 / 临床实验 / Sedation Strategies for Diagnostic Bronchoscopy 2

Sedation Strategies for Diagnostic Bronchoscopy 2

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bronchoscopy Sedation Drug: Midazolam Drug: Fentanyl Drug: Dexmedetomidine Drug: Remifentanil Drug: Propofol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
Estimated Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. Cough score [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours ]
    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


Secondary Outcome Measures :
  1. Body movement [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours ]
    The numbers of the times of any body movement across the procedure

  2. Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 2 hours ]
    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.

  3. Amount of the rescue use of propofol [ Time Frame: After sedation induction, assessed up to 2 hours ]
    The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.

  4. Recovery time [ Time Frame: After termination of the sedation medication, assessed up to 2 hours ]
    Duration of the recovery from sedation

  5. Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation duration, assessed up to 2 hours ]
    The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: Jia-feng Wang, MD +862131161869 jfwang@smmu.edu.cn
Contact: Xiao-ming Deng, MD +862131161837 deng_x@yahoo.com

Locations
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China, Shanghai
Faculty of Anesthesiology, Changhai Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Shanghai Zhongshan Hospital
Ruijin Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 14, 2019
Estimated Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		Cough score [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Body movement [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours ]
    The numbers of the times of any body movement across the procedure
  • Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 2 hours ]
    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.
  • Amount of the rescue use of propofol [ Time Frame: After sedation induction, assessed up to 2 hours ]
    The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.
  • Recovery time [ Time Frame: After termination of the sedation medication, assessed up to 2 hours ]
    Duration of the recovery from sedation
  • Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation duration, assessed up to 2 hours ]
    The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Body movement [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 2 hours ]
    The numbers of the times of any body movement across the procedure
  • Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 2 hours ]
    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.
  • Amount of the rescue use of propofol [ Time Frame: After sedation induction, assessed up to 2 hours ]
    The total amount of propofol used as a rescue therapy when the sedation is not deep enough as assessed by the anesthesiologists.
  • Recovery time [ Time Frame: After termination of the sedation medication, assessed up to 2 hours ]
    Duration of the recovery from sedation
  • Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation duration, assessed up to 2 hours ]
    The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedation Strategies for Diagnostic Bronchoscopy 2
Official Title  ICMJE The Effect and Safety of Different Sedation Strategies for Diagnostic Bronchoscopy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bronchoscopy
  • Sedation
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: F
    Sedated with intravenous midazolam (0.03mg/kg) and fentanyl (1μg/kg) for induction and maintenance
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl
  • 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
    Interventions:
    • Drug: Midazolam
    • Drug: Dexmedetomidine
    • Drug: Remifentanil
  • 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
    Interventions:
    • Drug: Midazolam
    • Drug: Fentanyl
    • Drug: Dexmedetomidine
  • 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
    Interventions:
    • Drug: Midazolam
    • Drug: Remifentanil
    • Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983889
Other Study ID Numbers  ICMJE SED-DFB2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jia-feng Wang, Changhai Hospital
Study Sponsor  ICMJE Changhai Hospital
Collaborators  ICMJE
  • Shanghai Zhongshan Hospital
  • Ruijin Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China
Investigators  ICMJE Not Provided
PRS Account Changhai Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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