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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04170751
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Yonsei University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hypertension

Arms & Interventions

Arms

Experimental: group N

In group N, 16 mcg / cc of norepinephrine was infused to patients.

Experimental: group V

In group V, 0.4 unit / cc of vasopressin was infused to patients.

Interventions

Drug: - 16 mcg / cc of norepinephrine(group N)

In group N, 16 mcg / cc of norepinephrine was infused through the central catheter. Drug titration should be 0.05 mcg / min / kg for norepinephrine and 2 units / hr for vasopressin, until target blood pressure is reached. Drug infusion rate should not exceed 0.3mcg / min / kg for norepinephrine and 10unit / hr for vasopressin for patient's safety.

Drug: - 0.4 unit / cc of vasopressin(group V)

In group V, 0.4 unit / cc of vasopressin was infused through the central catheter and the respective doses recorded. Drug titration should be 0.05 mcg / min / kg for norepinephrine and 2 units / hr for vasopressin, until target blood pressure is reached. Drug infusion rate should not exceed 0.3mcg / min / kg for norepinephrine and 10unit / hr for vasopressin for patient's safety.

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