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

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

Patrocinadores

Patrocinador principal: Yonsei University

Fuente Yonsei University
Resumen breve

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.

Estado general Recruiting
Fecha de inicio November 18, 2019
Fecha de Terminación August 2020
Fecha de finalización primaria May 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
PaO2/FiO2 ratio about 20 minutes after reaching to the target blood pressure (T2)
Resultado secundario
Medida Periodo de tiempo
lung mechanics: lung compliance about 20 minutes after reaching to the target blood pressure (T2)
lung mechanics: dead space 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)
Inscripción 40
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: 16 mcg / cc of norepinephrine(group N)

Descripción: 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.

Etiqueta de grupo de brazo: group N

Tipo de intervención: Drug

Nombre de intervención: 0.4 unit / cc of vasopressin(group V)

Descripción: 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.

Etiqueta de grupo de brazo: group V

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 40 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Contacto general

Apellido: Young Jun Oh

Teléfono: 82-2-2228-2420

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine Young Jun Oh, MD +82-02-2228-2420 [email protected]
Ubicacion Paises

Korea, Republic of

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: group N

Tipo: Experimental

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

Etiqueta: group V

Tipo: Experimental

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

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: 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.

Propósito primario: Treatment

Enmascaramiento: Triple (Participant, Care Provider, Outcomes Assessor)

Descripción de enmascaramiento: 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.

Fuente: ClinicalTrials.gov