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

NCT02185430 | Completed

• 1 other identifier: 4-2014-0306
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COPD, One Lung Ventilation

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Control group

PLACEBO COMPARATOR

saline solution

Drug: saline infusion

dexmedetomidine group

ACTIVE COMPARATOR

dexmedetomidine

Drug: dexmedetomidine infusion

Interventions

saline infusion DRUG

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

Control group

dexmedetomidine infusion DRUG

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

dexmedetomidine group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Related Publications (1)

• 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.

  PMID: 26716866 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Young Jun Oh, MD,PhD

  Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10