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

Not Applicable

• Conditions: Hypertension
• Interventions: Drug: 0.4 unit / cc of vasopressin(group V); Drug: 16 mcg / cc of norepinephrine(group N)

• Registration Number: NCT04170751
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-17
• Study Start: 2019-11-18
• Study First Posted: 2019-11-20
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group V	0.4 unit / cc of vasopressin(group V)	In group V, 0.4 unit / cc of vasopressin was infused to patients.
group N	16 mcg / cc of norepinephrine(group N)	In group N, 16 mcg / cc of norepinephrine was infused to patients.

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio	about 20 minutes after reaching to the target blood pressure (T2)	(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2

Secondary Outcome Measures

Name	Time	Method
lung mechanics: airway pressure	about 20 minutes after reaching to the target blood pressure (T2)	airway pressure at T2 (mmHg)
lung mechanics: dead space	about 20 minutes after reaching to the target blood pressure (T2)	dead space = \[(PaCO2 - PetCO2)/PaCO2\] \* Tidal volume (ml)
lung mechanics: lung compliance	about 20 minutes after reaching to the target blood pressure (T2)	Compliance= tidal volume/plateau airway pressure (ml/mmHg)

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of