UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031084 |
|---|---|
| Receipt number | R000035119 |
| Scientific Title | Changes in tidal volume caused by nitrous oxide during general anesthesia |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2019/02/05 07:48:33 |
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Basic information
Public title
Changes in tidal volume caused by nitrous oxide during general anesthesia
Acronym
Changes in tidal volume caused by nitrous oxide during general anesthesia
Scientific Title
Changes in tidal volume caused by nitrous oxide during general anesthesia
Scientific Title:Acronym
Changes in tidal volume caused by nitrous oxide during general anesthesia
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of nitrous oxide on tidal volume during general anesthesia
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the tidal volume from the control
Key secondary outcomes
1. Changes in the lung compliance
2. Changes in the end tidal carbon dioxide
3. Changes in the end tidal sevoflurane concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Comfirm the recovery of the train-of-four ratio not less than 0.9 after intubation.
Sustain anesthesia with concentration of 1MAC sevoflurrane.
Ventilator setting is pressure control ventilation with PEEP 5 cmH2O, tidal volume of 8 mL/kg, and adequate respiratory rate which maintains end tidal carbon dioxide 35-40 mmHg. Initial fresh gas flow is 4 L/min at an FIO2 0.25 in air.
After measurement of control, we alter FIO2 value to 0.3 in air in non-administration of nitrous oxide group, and measure tidal volume every one minute for 5 minutes.
Interventions/Control_2
After measurement of control, we alter FIO2 value to 0.3 in nitrous oxide in administration of nitrous oxide(70%) group, and measure tidal volume every one minute for 5 minutes.
Interventions/Control_3
After measurement of control, we alter FIO2 value to 0.65 in nitrous oxide in administration of nitrous oxide(35%) group, and measure tidal volume every one minute for 5 minutes.
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
Key exclusion criteria
1. Past history of cardiac,respiratory,or neuromuscular disease
2. Thoracic surgery
3. Abdominal surgery
4. Upper respiratory infection
5. Extraordinary operation
Target sample size
20
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 | 01 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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 | 01 | Month | 31 | 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=R000035119
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
