- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03983915
Sedation Strategies for Therapeutic Bronchoscopy 2
June 12, 2019 updated by: Jia-feng Wang, Changhai Hospital
Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Faculty of Anesthesiology, Changhai Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group DR
Patients sedated with dexmedetomidine and remifentanil.
|
Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
Remifentanil was used to prevent cough induced by bronchoscopy.
|
EXPERIMENTAL: Group LMA
General anesthesia was applied using laryngeal mask.
|
Laryngeal mask was used to ensure respiration function during general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery time
Time Frame: After termination of the sedation medication, assessed up to 3 hours
|
Duration of the recovery from sedation
|
After termination of the sedation medication, assessed up to 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Across the procedure, assessed up to 3 hours
|
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.
|
Across the sedation or anesthesia, assessed up to 3 hours
|
Cost of anesthesia or sedation
Time Frame: Across the sedation or anesthesia, assessed up to 3 hours
|
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
|
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 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
|
From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Remifentanil
- Dexmedetomidine
Other Study ID Numbers
- SED-TFB2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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