Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Phase 4

Completed

Conditions: Bronchoscopy

Interventions: Drug: Dexmedetomidine arm
Drug: Propofol arm

Registration Number: NCT03521505

Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary: Preventing hypoxemia is one of the major goal of studies for bronchoscopic sedation. Dexmedetomidine is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. In the preset study, we evaluate the safety and feasibility of the Dexmedetomidine in the specific bronchoscopic procedure, endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration.

Detailed Description: Patients undergoing flexible bronchoscopy (FB) experience procedure-related symptoms. Current guidelines of FB recommend sedation to all patients undergoing FB, except when there are contraindications. Propofol plus an opioid is the common combination used to improve patient tolerance and satisfaction during FB. However, controversy about combining propofol and opioids persists because of the risk of over-sedation and cardiopulmonary depression, especially for the time-consuming endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA). Similar with other published data, around 40% of hypoxemia event was observed during FB sedation in the investigators' hospital. Dexmedetomidine, is a sedative agents via α2 adrenergic agonist, with little respiratory suppression. It has been applied in patients with mechanical ventilation, undergoing gastroendoscopy and extracorporal shockwave lithotripsy. Little evidences are available for Dexmedetomidine in sedation for EBUS-TBNA.

In this study, the investigators will evaluate the safety and feasibility of Dexmedetomidine for sedation of EBUS-TBNA comparing to Propofol for sedation of EBUS-TBNA. Generally, the FB sedation can divided into three parts: the induction (from starting sedative administration to insertion of bronchoscope); the maintenance ( from insertion of bronchoscope to its removal) and the recovery (from bronchoscope removal to patients gain consciousness). The primary endpoint is the proportion of patients with hypoxemia during maintenance of sedation. the investigators will also observe the other sedative outcomes, e.g. blood pressure, sedative drug dosing and patient tolerance and cooperation. The present study will also observe the association between brain perfusion and sedative outcomes via non-invasive monitor. Based on the unique pharmacokinetic property of Dexmedetomidine and the real-time brain perfusion monitor, Dexmedetomidine-based sedation may provide better safety profile for EBUS-TBNA than propofol and discover novel connection between sedative outcomes and brain perfusion.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients undergoing elective bronchoscopy and sedation

Exclusion Criteria

Age less than 20 years
American Society of Anaesthesiologists (ASA) physical status classification IV or V
Mallampati score of 4
Severe sleep apnoea syndrome (apnoea-hypopnea index more than 40)
Body mass index more than 42 in males or 35 in females
Neurologic disorders or other conditions contributing to difficulty in assessing response
Forced expiratory vital capacity (FVC) less than 15 ml/kg body weight, forced expiratory volume in one second (FEV1) less than 1000 ml, or FEV1/FVC less than 35%
History of second or third degree atrioventricular block, heat rate less than 50 beat per minute or systolic blood pressure less than 90 mmHg
Pregnancy
Patients with a known history of allergy to the study drugs, or to eggs, soybeans or sulfite products

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine arm	Dexmedetomidine arm	Dexmedetomidine will be administrated for sedation of EBUS-TBNA
Propofol arm	Propofol arm	Propofol will be administrated for sedation of EBUS-TBNA

Primary Outcome Measures

Name	Time	Method
Hypoxemia During Maintenance	After starting bronchoscopy, up to 120 minutes	The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during maintenance of Bronchoscopic sedation

Secondary Outcome Measures

Name	Time	Method
Hypoxemia During Induction	After starting induction, up to 30 minutes.	The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)\<90%) during induction of bronchoscopic sedation
The Global Tolerance for Bronchoscopy	After recovery from sedation, up to 120 minutes	The Global Tolerance of patients for bronchoscopy will be evaluated by 100-mm visual analogue scale (VAS, 0: no bother, 100: worst intolerable) after recovery
Hypotension During Bronchoscopic Sedation	After starting sedation, up to 120 minutes.	The percentage of patients with hypotension (mean arterial blood pressure (MAP) less than 65 mmHg with any duration.
Bradycardia During Bronchoscopic Sedation	After starting sedation, up to 120 minutes.	The percentage of patients with bradycardia (heat beat per minute less than 60)
The Cooperation of Patients From the View of Bronchoscopists	After recovery from sedation, up to 120 minutes	The Cooperation of Patients will be evaluated by 100-mm visual analogue scale (VAS, 0: well cooperation, 100: worst cooperation) after recovery.
Procedure Time and Recovery Time	After starting bronchoscopy, up to 120 minutes.	The procedure time of bronchoscopy and recovery time from sedation to awake.