Bronchoscopy, Sedation
Conditions
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.
Interventions
DRUGDexmedetomidine
Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
DRUGRemifentanil
Remifentanil was used to prevent cough induced by bronchoscopy.
DEVICELaryngeal mask
Laryngeal mask was used to ensure respiration function during general anesthesia.
Sponsors
Shanghai Zhongshan Hospital
Ruijin Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery time | After termination of the sedation medication, assessed up to 3 hours | Duration of the recovery from sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score of the patients and bronchoscopists | 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. |
| Prevalence of the side effects of respiratory and circulatory system | 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. |
| 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 | 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 |
| 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 | The numbers of the times of any body movement across the procedure |
Countries
China
Outcome results
None listed