UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032596 |
|---|---|
| Receipt number | 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 07:47:32 |
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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
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
tmn316@yahoo.co.jp
Sponsor or person
Institute
Miyagi children's hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037166
