Effects of Dexmedetomidine on Respiratory Mechanics and Oxygenation During One Lung Ventilation With Chronic Obstructive Lung Disease

COPD is often associated with the airflow limitation and the pulmonary hyperinflation. During the one-lung ventilation (OLV), COPD patients' physiologic dead space increases and hypercapnia may develop. In addition, an alveolar overdistention by the pulmonary hyperinflation would divert pulmonary blood flow and impair arterial oxygenation. Dexmedetomidine has both vasoconstricting and vasodilatatory effects on a peripheral vasculature and a smooth muscle but its effects on bronchial smooth muscle is unknown. The investigators will evaluate the effects of dexmedetomidine (bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation) as bronchodilator in COPD patients when administered during surgery with the one lung ventilation. If result successfully shows the effect of dexmedetomidine as a predominantly a vasodilator on bronchial tree, the investigators study can support the dexmedetomidine as a vasodilator for pulmonary vessels and bronchial smooth muscle and as an excellent adjunct to anesthetic agents in COPD patients during the OLV.

Study Overview

• Status: Completed
• Conditions: COPD, One Lung Ventilation
• Intervention / Treatment: Drug: saline infusion; Drug: dexmedetomidine infusion

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Above 40 years of age
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. COPD diagnosed , criteria ( on preop. PFT : FEV1 < 80%, FEV1 / FVC < 70% after bronchodilator)
4. thoracic surgical procedure

Exclusion Criteria:

1. severe functional liver or kidney disease
2. diagnosed HF ( NYHA class >3)
3. arrhythmia or received treatment with antiarrythmic drug .
4. exceed BMI > 30 kg/ m2
5. bradycardia (HR <50 bpm)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; saline solution	Drug: saline infusion; saline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
Active Comparator: dexmedetomidine group; dexmedetomidine	Drug: dexmedetomidine infusion; dexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the oxygenation	PaO2/FiO2 ratio	At two-lung ventilation (T1) , 20 min after of one-lung ventilation (T2), 30 mins after Dex or placebo saline infusion (T3), 60 mins after Dex or placebo saline infusion (T4), at the termination of surgery in TLV (T5)

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Lee SH, Kim N, Lee CY, Ban MG, Oh YJ. Effects of dexmedetomidine on oxygenation and lung mechanics in patients with moderate chronic obstructive pulmonary disease undergoing lung cancer surgery: A randomised double-blinded trial. Eur J Anaesthesiol. 2016 Apr;33(4):275-82. doi: 10.1097/EJA.0000000000000405.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 11, 2015
• Last Verified: October 1, 2015

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; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 4-2014-0306