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Clinical Trials/NCT03406546
NCT03406546
Terminated
Not Applicable

Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy

Changhai Hospital1 site in 1 country20 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Bronchoscopy
Sponsor
Changhai Hospital
Enrollment
20
Locations
1
Primary Endpoint
Recovery time
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
July 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jia-feng Wang

MD

Changhai Hospital

Eligibility 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

Arms & Interventions

Group DR

Patients sedated with dexmedetomidine and remifentanil.

Intervention: Dexmedetomidine

Group DR

Patients sedated with dexmedetomidine and remifentanil.

Intervention: Remifentanil

Group LMA

General anesthesia was applied using laryngeal mask.

Intervention: Laryngeal mask

Outcomes

Primary Outcomes

Recovery time

Time Frame: After termination of the sedation medication, assessed up to 3 hours

Duration of the recovery from sedation

Secondary Outcomes

  • Cost of anesthesia or sedation(Across the sedation or anesthesia, assessed up to 3 hours)
  • Cough score(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(From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours)
  • Satisfaction score of the patients and bronchoscopists(Across the procedure, assessed up to 3 hours)
  • Prevalence of the side effects of respiratory and circulatory system(Across the sedation or anesthesia, assessed up to 3 hours)

Study Sites (1)

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