Dexmedetomidine for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Dexmedetomidine and Brain Perfusion Monitor for Sedation of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

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.

Study Overview

• Status: Completed
• Conditions: Bronchoscopy
• Intervention / Treatment: Drug: Dexmedetomidine arm; Drug: Propofol arm

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33305
    • Department of Thoracic Medicine, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine arm; Dexmedetomidine will be administrated for sedation of EBUS-TBNA	Drug: Dexmedetomidine arm; Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration
Active Comparator: Propofol arm; Propofol will be administrated for sedation of EBUS-TBNA	Drug: Propofol arm; 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2. Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia During Induction	The percentage of patients with hypoxemia (oxyhemoglobin saturation (SpO2)<90%) during induction of bronchoscopic sedation	After starting induction, up to 30 minutes.
The Global Tolerance for Bronchoscopy	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	After recovery from sedation, up to 120 minutes
The Cooperation of Patients From the View of Bronchoscopists	The Cooperation of Patients will be evaluated by 100-mm visual analogue scale (VAS, 0: well cooperation, 100: worst cooperation) after recovery.	After recovery from sedation, up to 120 minutes
Hypotension During Bronchoscopic Sedation	The percentage of patients with hypotension (mean arterial blood pressure (MAP) less than 65 mmHg with any duration.	After starting sedation, up to 120 minutes.
Bradycardia During Bronchoscopic Sedation	The percentage of patients with bradycardia (heat beat per minute less than 60)	After starting sedation, up to 120 minutes.
Procedure Time and Recovery Time	The procedure time of bronchoscopy and recovery time from sedation to awake.	After starting bronchoscopy, up to 120 minutes.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Ting-Yu Lin, M.D., Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• Ryu JH, Lee SW, Lee JH, Lee EH, Do SH, Kim CS. Randomized double-blind study of remifentanil and dexmedetomidine for flexible bronchoscopy. Br J Anaesth. 2012 Mar;108(3):503-11. doi: 10.1093/bja/aer400. Epub 2011 Dec 15.
• Lin TY, Lo YL, Hsieh CH, Ni YL, Wang TY, Lin HC, Wang CH, Yu CT, Kuo HP. The potential regimen of target-controlled infusion of propofol in flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2013 Apr 24;8(4):e62744. doi: 10.1371/journal.pone.0062744. Print 2013.
• Lo YL, Lin TY, Fang YF, Wang TY, Chen HC, Chou CL, Chung FT, Kuo CH, Feng PH, Liu CY, Kuo HP. Feasibility of bispectral index-guided propofol infusion for flexible bronchoscopy sedation: a randomized controlled trial. PLoS One. 2011;6(11):e27769. doi: 10.1371/journal.pone.0027769. Epub 2011 Nov 23.
• Lin TY, Fang YF, Huang SH, Wang TY, Kuo CH, Wu HT, Kuo HP, Lo YL. Capnography monitoring the hypoventilation during the induction of bronchoscopic sedation: A randomized controlled trial. Sci Rep. 2017 Aug 17;7(1):8685. doi: 10.1038/s41598-017-09082-8.
• Lin TY, Huang YC, Kuo CH, Chung FT, Lin YT, Wang TY, Lin SM, Lo YL. Dexmedetomidine sedation for endobronchial ultrasound-guided transbronchial needle aspiration, a randomised controlled trial. ERJ Open Res. 2020 Nov 10;6(4):00064-2020. doi: 10.1183/23120541.00064-2020. eCollection 2020 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: April 28, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: August 15, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: bronchoscopy; dexmedetomidine; Sedation; brain perfusion
• 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; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 201601093A3

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes