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
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
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
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
