Clinical trial NCT04170751: Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study
Official title: Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: lobectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients enrolled were divided into norepinephrine (group N) and vasopressin (group V) by random random numbers. The ratio of each group should be 1: 1.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy with unilateral lung ventilation during surgery.
2. Patients taking hypertension drug CCB(calcium channel blocker), ARB(angiotensin II receptor blocker), ACEi(ACE inhibitor, angiotensin converting enzyme inhibitor) at least 4 weeks.
3. American Society of Anesthesiologists (ASA) classification 2\~3

Exclusion Criteria:

1. patients with heart failure (NYHA class III\~IV)
2. patients who are having moderate obstructive lung disease or restrictive lung disease
3. Low DLCO (\< 75%)
4. patients with pulmonary hypertension (mean PAP\>25mmHg)
5. patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
6. body mass index (BMI) \> 30 kg/m2
7. patients who cannot read explanation and consent form
8. patients who are pregnant

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: about 20 minutes after reaching to the target blood pressure (T2)
Secondary outcomes:
measure: lung mechanics: lung compliance
timeFrame: about 20 minutes after reaching to the target blood pressure (T2)
measure: lung mechanics: dead space
timeFrame: about 20 minutes after reaching to the target blood pressure (T2)
measure: lung mechanics: airway pressure
timeFrame: about 20 minutes after reaching to the target blood pressure (T2)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References: