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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04170751

Collaborator

(none)

Enrollment

Location

Arms

21.5

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: 16 mcg / cc of norepinephrine(group N) Drug: 0.4 unit / cc of vasopressin(group V)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 18, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group N In group N, 16 mcg / cc of norepinephrine was infused to patients.	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.
Experimental: group V In group V, 0.4 unit / cc of vasopressin was infused to patients.	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.

Arm

Intervention/Treatment

Experimental: group N

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

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.

Experimental: group V

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

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.

Outcome Measures

Primary Outcome Measures

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

lung mechanics: lung compliance [about 20 minutes after reaching to the target blood pressure (T2)]
Compliance= tidal volume/plateau airway pressure (ml/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: airway pressure [about 20 minutes after reaching to the target blood pressure (T2)]
airway pressure at T2 (mmHg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy with unilateral lung ventilation during surgery.
Patients taking hypertension drug CCB(calcium channel blocker), ARB(angiotensin II receptor blocker), ACEi(ACE inhibitor, angiotensin converting enzyme inhibitor) at least 4 weeks.
American Society of Anesthesiologists (ASA) classification 2~3

Exclusion Criteria:

patients with heart failure (NYHA class III~IV)
patients who are having moderate obstructive lung disease or restrictive lung disease
Low DLCO (< 75%)
patients with pulmonary hypertension (mean PAP>25mmHg)
patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
body mass index (BMI) > 30 kg/m2
patients who cannot read explanation and consent form
patients who are pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04170751

Other Study ID Numbers:

4-2019-0696

First Posted:

Nov 20, 2019

Last Update Posted:

May 4, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yonsei University

lobectomy

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2021