Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Yonsei University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- PaO2/FiO2 ratio
Study Overview
Brief Summary
Hypotension during anesthesia often occurs because reduced systemic vascular resistance and blocked sympathetic nervous system by anesthetic drugs. In patients who are taking hypertension medication, blood pressure drops are exaggerated by inadequate compensation mechanism due to decrease of blood vessel elasticity and desensitization of baroreceptors. In one-lung ventilation (OLV) during thoracic surgery, persistent perfusion of non-ventilatory lungs can lead to increased intra-pulmonary shunt and hypoxemia. As a compensatory mechanism, the gravitational effect and hypoxic pulmonary vasoconstriction occur. Among these, hypoxic pulmonary vasoconstriction is associated with pulmonary vascular resistance. Norepinephrine and vasopressin, which are commonly used in patients with hypotension, affect systemic and pulmonary vascular resistance. However, no studies have been done on lung oxygenation and pulmonary mechanics of these vasoactive drugs in patients undergoing surgery on one lung. Therefore, the purpose of this study is to investigate the effects of vasoactive drugs, norepinephrine and vasopressin, in patients with hypertension.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Patients, care givers and outcomes assessors are blinded. The investigator should not be included in the blind because the drug must be rate controlled during investigations.
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy with unilateral lung ventilation during surgery.
- •Patients taking hypertension drug CCB(calcium channel blocker), ARB(angiotensin II receptor blocker), ACEi(ACE inhibitor, angiotensin converting enzyme inhibitor) at least 4 weeks.
- •American Society of Anesthesiologists (ASA) classification 2~3
Exclusion Criteria
- •patients with heart failure (NYHA class III~IV)
- •patients who are having moderate obstructive lung disease or restrictive lung disease
- •Low DLCO (< 75%)
- •patients with pulmonary hypertension (mean PAP>25mmHg)
- •patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
- •body mass index (BMI) > 30 kg/m2
- •patients who cannot read explanation and consent form
- •patients who are pregnant
Arms & Interventions
group N
In group N, 16 mcg / cc of norepinephrine was infused to patients.
Intervention: 16 mcg / cc of norepinephrine(group N) (Drug)
group V
In group V, 0.4 unit / cc of vasopressin was infused to patients.
Intervention: 0.4 unit / cc of vasopressin(group V) (Drug)
Outcomes
Primary Outcomes
PaO2/FiO2 ratio
Time Frame: about 20 minutes after reaching to the target blood pressure (T2)
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2
Secondary Outcomes
- lung mechanics: dead space(about 20 minutes after reaching to the target blood pressure (T2))
- lung mechanics: lung compliance(about 20 minutes after reaching to the target blood pressure (T2))
- lung mechanics: airway pressure(about 20 minutes after reaching to the target blood pressure (T2))