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

Sedation Strategies for Therapeutic Bronchoscopy 2

Study Description
Brief Summary:
Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.

Condition or disease Intervention/treatment Phase
Bronchoscopy Sedation Drug: Dexmedetomidine Drug: Remifentanil Device: Laryngeal mask Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic 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: Group DR
Patients sedated with dexmedetomidine and remifentanil.
 Drug: Dexmedetomidine
Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.

Drug: Remifentanil
Remifentanil was used to prevent cough induced by bronchoscopy.
Experimental: Group LMA
General anesthesia was applied using laryngeal mask.
 Device: Laryngeal mask
Laryngeal mask was used to ensure respiration function during general anesthesia.
Outcome Measures
Primary Outcome Measures :
  1. Recovery time [ Time Frame: After termination of the sedation medication, assessed up to 3 hours ]
    Duration of the recovery from sedation


Secondary Outcome Measures :
  1. Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 3 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.

  2. Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
    The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.

  3. Cost of anesthesia or sedation [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
  4. Cough score [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 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

  5. The numbers of the times of body movement [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours ]
    The numbers of the times of any body movement across the procedure


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 therapeutic 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) 		Recovery time [ Time Frame: After termination of the sedation medication, assessed up to 3 hours ]
Duration of the recovery from sedation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 3 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.
  • Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
    The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tachycardia, bradycardia, hypoxia and larynx spasm.
  • Cost of anesthesia or sedation [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
  • Cough score [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 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
  • The numbers of the times of body movement [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours ]
    The numbers of the times of any body movement across the procedure
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 3 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.
  • Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
    The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.
  • Cost of anesthesia or sedation [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
  • Cough score [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 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
  • The numbers of the times of body movement [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours ]
    The numbers of the times of any body movement across the procedure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedation Strategies for Therapeutic Bronchoscopy 2
Official Title  ICMJE Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
Brief Summary Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bronchoscopy
  • Sedation
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
  • Drug: Remifentanil
    Remifentanil was used to prevent cough induced by bronchoscopy.
  • Device: Laryngeal mask
    Laryngeal mask was used to ensure respiration function during general anesthesia.
Study Arms  ICMJE
  • Experimental: Group DR
    Patients sedated with dexmedetomidine and remifentanil.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Remifentanil
  • Experimental: Group LMA
    General anesthesia was applied using laryngeal mask.
    Intervention: Device: Laryngeal mask
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) 		80
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 therapeutic 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 NCT03983915
Other Study ID Numbers  ICMJE SED-TFB2
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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