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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170751
• Other study ID #: 4-2019-0696
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: September 2021

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: Young Jun Oh
• Phone: 82-2-2228-2420
• Email: yjoh[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2	about 20 minutes after reaching to the target blood pressure (T2)
Secondary	lung mechanics: lung compliance	Compliance= tidal volume/plateau airway pressure (ml/mmHg)	about 20 minutes after reaching to the target blood pressure (T2)
Secondary	lung mechanics: dead space	dead space = [(PaCO2 - PetCO2)/PaCO2] * Tidal volume (ml)	about 20 minutes after reaching to the target blood pressure (T2)
Secondary	lung mechanics: airway pressure	airway pressure at T2 (mmHg)	about 20 minutes after reaching to the target blood pressure (T2)