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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
16 mcg / cc of norepinephrine(group N)
0.4 unit / cc of vasopressin(group V)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring lobectomy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group N

group V

Arm Description

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

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

Outcomes

Primary Outcome Measures

PaO2/FiO2 ratio
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2

Secondary Outcome Measures

lung mechanics: lung compliance
Compliance= tidal volume/plateau airway pressure (ml/mmHg)
lung mechanics: dead space
dead space = [(PaCO2 - PetCO2)/PaCO2] * Tidal volume (ml)
lung mechanics: airway pressure
airway pressure at T2 (mmHg)

Full Information

First Posted
November 12, 2019
Last Updated
May 3, 2021
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04170751
Brief Title
Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study
Official Title
Effect of Vasopressin vs Norepinephrine on Pulmonary Oxygenation and Lung Mechanics in Patients With Hypertension Therapy During One-lung Ventilation : Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
lobectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group N
Arm Type
Experimental
Arm Description
In group N, 16 mcg / cc of norepinephrine was infused to patients.
Arm Title
group V
Arm Type
Experimental
Arm Description
In group V, 0.4 unit / cc of vasopressin was infused to patients.
Intervention Type
Drug
Intervention Name(s)
16 mcg / cc of norepinephrine(group N)
Intervention Description
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
Intervention Name(s)
0.4 unit / cc of vasopressin(group V)
Intervention Description
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.
Primary Outcome Measure Information:
Title
PaO2/FiO2 ratio
Description
(arterial oxygen partial pressure / fractional inspired oxygen) at the time of T2
Time Frame
about 20 minutes after reaching to the target blood pressure (T2)
Secondary Outcome Measure Information:
Title
lung mechanics: lung compliance
Description
Compliance= tidal volume/plateau airway pressure (ml/mmHg)
Time Frame
about 20 minutes after reaching to the target blood pressure (T2)
Title
lung mechanics: dead space
Description
dead space = [(PaCO2 - PetCO2)/PaCO2] * Tidal volume (ml)
Time Frame
about 20 minutes after reaching to the target blood pressure (T2)
Title
lung mechanics: airway pressure
Description
airway pressure at T2 (mmHg)
Time Frame
about 20 minutes after reaching to the target blood pressure (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Jun Oh
Phone
82-2-2228-2420
Email
yjoh@yuhs.ac
Facility Information:
Facility Name
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Jun Oh, MD
Phone
+82-02-2228-2420
Email
YJOH@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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