Sedation Strategies for Therapeutic Bronchoscopy

NCT03406546 | Terminated DMC

• 1 other identifier: SED-TFB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchoscopy; Sedation

Outcome Measures

Primary Outcomes (1)

• Recovery time

  Duration of the recovery from sedation

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

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

Group DR

EXPERIMENTAL

Patients sedated with dexmedetomidine and remifentanil.

Drug: Dexmedetomidine; Drug: Remifentanil

Group LMA

EXPERIMENTAL

General anesthesia was applied using laryngeal mask.

Device: Laryngeal mask

Interventions

Dexmedetomidine DRUG

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

Group DR

Remifentanil DRUG

Remifentanil was used to prevent cough induced by bronchoscopy.

Group DR

Laryngeal mask DEVICE

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

Group LMA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Zhongshan Hospital: collaborator
• Ruijin Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Study Sites (1)

Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil; Laryngeal Masks

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 23, 2018
• Study Start: February 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 31, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

CN (1)