Sedation Strategies for Therapeutic Bronchoscopy

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

• Status: Terminated
• Conditions: Sedation; Bronchoscopy
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Remifentanil; Device: Laryngeal mask

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Faculty of Anesthesiology, Changhai Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group DR; Patients sedated with dexmedetomidine and remifentanil.	Drug: Dexmedetomidine; Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.; Drug: Remifentanil; Remifentanil was used to prevent cough induced by bronchoscopy.
Experimental: Group LMA; General anesthesia was applied using laryngeal mask.	Device: 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	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	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
Cost of anesthesia or sedation		Across the sedation or anesthesia, assessed up to 3 hours
Cough score	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	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
Prevalence of the side effects of respiratory and circulatory system	The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.	Across the sedation or anesthesia, assessed up to 3 hours

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shanghai Zhongshan Hospital; Ruijin Hospital; Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: SED-TFB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No