Sedation Strategies for Therapeutic Bronchoscopy

NCT ID: NCT03406546

Last Updated: 2019-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2018-07-31

Brief Summary

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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

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Conditions

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Bronchoscopy Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group DR

Patients sedated with dexmedetomidine and remifentanil.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.

Remifentanil

Intervention Type DRUG

Remifentanil was used to prevent cough induced by bronchoscopy.

Group LMA

General anesthesia was applied using laryngeal mask.

Group Type EXPERIMENTAL

Laryngeal mask

Intervention Type DEVICE

Laryngeal mask was used to ensure respiration function during general anesthesia.

Interventions

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Dexmedetomidine

Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.

Intervention Type DRUG

Remifentanil

Remifentanil was used to prevent cough induced by bronchoscopy.

Intervention Type DRUG

Laryngeal mask

Laryngeal mask was used to ensure respiration function during general anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jia-feng Wang

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SED-TFB

Identifier Type: -

Identifier Source: org_study_id

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