UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024317
Receipt number R000028009
Scientific Title The effects of phenylephrine on oxygenation during one-lung ventilation; a randomized, double-blind, cross-over study
Date of disclosure of the study information 2016/10/06
Last modified on 2020/09/16 17:11:17

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Basic information

Public title

The effects of phenylephrine on oxygenation during one-lung ventilation; a randomized, double-blind, cross-over study

Acronym

The effects of phenylephrine on oxygenation during one-lung ventilation

Scientific Title

The effects of phenylephrine on oxygenation during one-lung ventilation; a randomized, double-blind, cross-over study

Scientific Title:Acronym

The effects of phenylephrine on oxygenation during one-lung ventilation

Region

Japan


Condition

Condition

Adult patients undergoing elective thoracic surgery in the lateral decubitus position with at least 70 minutes of one-lung ventilation

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of phenylephrine infusion on oxygenation during one-lung ventilation in patients undergoing thoracic surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Arterial oxygen pressure after intervention

Key secondary outcomes

Mean Arterial Pressure, HeartRate, Pulse Pressure Variation, Perfusion Index, and Difference between Bladder Temperature and Skin Temperature


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Intravenous phenylephrine infusion (20 mL/h = 15 mcg/min) for 30 minutes

Interventions/Control_2

Normal Saline infusion at a speed of 20 mL/h for 30 minutes

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Adult patients with ASA physical status 1-3 undergoing elective thoracic surgery in the lateral decubitus position with at least 70 minutes of one-lung ventilation

Key exclusion criteria

History of stroke, uncompensated cardiac disease, or arrhythmias

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Kohei
Middle name
Last name Godai

Organization

Kagoshima University Hospital

Division name

Department of Anesthesiology

Zip code

890-8520

Address

8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan

TEL

+81-99-275-5430

Email

kouhei84@m2.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Godai

Organization

Kagoshima University Hospital

Division name

Department of Anesthesiology

Zip code

890-8520

Address

8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan

TEL

+81-99-275-5430

Homepage URL


Email

kouhei84@m2.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Kagoshima University

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medical and Dental Sciences, Kagoshima University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kagoshima University Hospital Clinical Research Management Center

Address

8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan

Tel

+81-99-275-6624

Email

crmc@m2.kufm.kagoshima-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 06 Day


Related information

URL releasing protocol

https://doi.org/10.1371/journal.pone.0195576.s003

Publication of results

Published


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028009

Number of participants that the trial has enrolled

35

Results

Twenty-nine patients were analyzed. Although phenylephrine infusion significantly increased mean arterial pressure (P < 0.001), arterial partial pressure of oxygen did not differ between the two timepoints (P = 0.19). There was no carryover effect in arterial partial pressure of oxygen (P = 0.14). Phenylephrine infusion significantly decreased heart rate (P = 0.02) and pulse pressure variation (P < 0.001).

Results date posted

2020 Year 09 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Inclusion criteria were patients with American Society of Anesthesiologists physical status 1 to 3 undergoing elective thoracic surgery in the lateral decubitus position with at least 70 minutes of OLV.

Participant flow

A total of 35 patients were included in the study; however, only the data from 29 patients were analyzed, as six patients did not receive their allocated intervention due to protocol violations.

Adverse events

No patient had any surgical or other perioperative complications.

Outcome measures

The primary outcome was PaO2. The secondary outcomes were MAP, HR, PPV, PI, and the difference between the bladder and skin temperature.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 06 Day

Date of IRB

2015 Year 11 Month 11 Day

Anticipated trial start date

2016 Year 10 Month 06 Day

Last follow-up date

2017 Year 11 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 06 Day

Last modified on

2020 Year 09 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028009


Research Plan
Registered date File name
2018/01/30 20160217 HPV臨床研究倫理委員会 申請書.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/03/14 20180225 HPV phenylephrine data.xlsx