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

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

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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