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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032596
Receipt No. R000037166
Scientific Title Changes in respiratory status caused by nitrous oxide during general anesthesia
Date of disclosure of the study information 2018/05/15
Last modified on 2019/02/05

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Basic information
Public title Changes in respiratory status caused by nitrous oxide during general anesthesia
Acronym Changes in respiratory status caused by nitrous oxide during general anesthesia
Scientific Title Changes in respiratory status caused by nitrous oxide during general anesthesia
Scientific Title:Acronym Changes in respiratory status caused by nitrous oxide during general anesthesia
Region
Japan

Condition
Condition Patients who undergo general anesthesia
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of nitrous oxide on tidal volume and partial pressure of end tidal and arterial carbon dioxide
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the tidal volume and partial pressure of end tidal and arterial carbon dioxide from the control
Key secondary outcomes 1. Changes in the lung compliance
2. Changes in the airway resistance
3. Body temperature
4. Cahanges in the end tidal sevoflurane concentration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We sustain anesthesia with concentration of 1MAC sevoflurane. Ventilator setting is pressure control ventilation with PEEP 5 cmH2O, tidal volume about 8 mL/kg, and adequate respiratory rate which maintains partial pressure of end tidal carbon dioxide 35-40 mmHg. Initial fresh gas flow is 4 L/min at an FIO2 0.25 in air. We measure respiratory status (tidal volume and partial pressure of end tidal and arterial carbon dioxide) as the control-1.
After measurement of the control-1, we alter FIO2 value to 0.3 in air and measure respiratory status as the air group 10 minutes or more after alteration.
Interventions/Control_2 After measurement of the air group, we alter FIO2 value to 0.25 again and measure respiratory status as the control-2 10 minutes or more after alteration.
After measurement of the control-2, we alter FIO2 value to 0.3 in nitrous oxide and measure respiratory status as the nitrous oxide group 10 minutes or more after alteration.
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
1 years-old <=
Age-upper limit
12 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who undergo surgery at our hospital with general anesthesia using inhalational anesthetic
2. Supine position,
3. ASA-PS1,2
4. Intubated cuffed tracheal tube
5. Monitored with arterial line
Key exclusion criteria 1. Patient who have cardiac, respiratory, or neuromuscular disease
2. Patient who have upper respiratory infection
3. Extraordinary operation
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonari Shinozaki
Organization Miyagi children's hospital
Division name department of anesthesiology
Zip code
Address 4-3-17, Ochiai, Aoba-ku Sendai-shi, Miyagi, Japan
TEL 022-391-5111
Email tmn316@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonari Shinozaki
Organization Miyagi children's hospital
Division name department of anesthesiology
Zip code
Address 4-3-17, Ochiai, Aoba-ku Sendai-shi, Miyagi, Japan
TEL 022-391-5111
Homepage URL
Email tmn316@yahoo.co.jp

Sponsor
Institute Miyagi children's hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 15 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037166

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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