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

NCT ID: NCT04170751

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2021-09-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

group N

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

Group Type: EXPERIMENTAL

16 mcg / cc of norepinephrine(group N)

Intervention Type: DRUG

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.

group V

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

Group Type: EXPERIMENTAL

0.4 unit / cc of vasopressin(group V)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Young Jun Oh

Role: CONTACT

yjoh@yuhs.ac

82-2-2228-2420

Facility Contacts

Young Jun Oh, MD

Role: primary

YJOH@yuhs.ac

+82-02-2228-2420

Other Identifiers

4-2019-0696

Identifier Type: -

Identifier Source: org_study_id