Sedation Strategies for Therapeutic Bronchoscopy

• ClinicalTrials.gov Identifier: NCT03406546
• Recruitment Status: Terminated
• First Posted: January 23, 2018
• Last Update Posted: June 12, 2019
• Sponsor: Changhai Hospital
• Collaborators: Shanghai Zhongshan Hospital; Ruijin Hospital; Shanghai Pulmonary Hospital, Shanghai, China
• Information provided by (Responsible Party): Jia-feng Wang, Changhai Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bronchoscopy; Sedation	Drug: Dexmedetomidine; Drug: Remifentanil; Device: Laryngeal mask	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
• Actual Study Start Date: February 1, 2018
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Recovery time [ Time Frame: After termination of the sedation medication, assessed up to 3 hours ]
   Duration of the recovery from sedation

Secondary Outcome Measures :

1. Satisfaction score of the patients and bronchoscopists [ Time Frame: Across the procedure, assessed up to 3 hours ]
   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.
2. Prevalence of the side effects of respiratory and circulatory system [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
   The number of the side effects in respiratory and circulatory system during the procedure, including hypertension, hypotension, tackycardia, bradycardia, hypoxia and larynx spasm.
3. Cost of anesthesia or sedation [ Time Frame: Across the sedation or anesthesia, assessed up to 3 hours ]
4. Cough score [ Time Frame: From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours ]
   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
5. The numbers of the times of body movement [ Time Frame: 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 any body movement across the procedure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Shanghai

Faculty of Anesthesiology, Changhai Hospital

Shanghai, Shanghai, China, 200433

Sponsors and Collaborators

Changhai Hospital

Shanghai Zhongshan Hospital

Ruijin Hospital

Shanghai Pulmonary Hospital, Shanghai, China

More Information

• Responsible Party: Jia-feng Wang, MD, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT03406546
• Other Study ID Numbers: SED-TFB
• First Posted: January 23, 2018
• Last Update Posted: June 12, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dexmedetomidine; Remifentanil; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics