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Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study

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Yonsei University

Status

Unknown

Conditions

Hypertension

Treatments

Drug: 16 mcg / cc of norepinephrine(group N)
Drug: 0.4 unit / cc of vasopressin(group V)

Study type

Interventional

Funder types

Other

Identifiers

NCT04170751
4-2019-0696

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

group N
Experimental group
Description:
In group N, 16 mcg / cc of norepinephrine was infused to patients.
Treatment:
Drug: 16 mcg / cc of norepinephrine(group N)
group V
Experimental group
Description:
In group V, 0.4 unit / cc of vasopressin was infused to patients.
Treatment:
Drug: 0.4 unit / cc of vasopressin(group V)

Trial contacts and locations

1

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Central trial contact

Young Jun Oh

Data sourced from clinicaltrials.gov

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