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Sedation Strategies for Therapeutic Bronchoscopy 2

N

Naval Military Medical University

Status

Unknown

Conditions

Sedation
Bronchoscopy

Treatments

Drug: Dexmedetomidine
Device: Laryngeal mask
Drug: Remifentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT03983915
SED-TFB2

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Group DR
Experimental group
Description:
Patients sedated with dexmedetomidine and remifentanil.
Treatment:
Drug: Remifentanil
Drug: Dexmedetomidine
Group LMA
Experimental group
Description:
General anesthesia was applied using laryngeal mask.
Treatment:
Device: Laryngeal mask

Trial contacts and locations

1

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Central trial contact

Xiao-ming Deng, MD; Jia-feng Wang, MD

Data sourced from clinicaltrials.gov

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