UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022288 |
|---|---|
| Receipt number | R000023127 |
| Scientific Title | Effect of nitrous oxide on the cardiac autonomic system during anesthesia induction in preschool children |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/05/12 12:12:07 |
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Basic information
Public title
Effect of nitrous oxide on the cardiac autonomic system during anesthesia induction in preschool children
Acronym
Nitrous oxide on autonomic function in children
Scientific Title
Effect of nitrous oxide on the cardiac autonomic system during anesthesia induction in preschool children
Scientific Title:Acronym
Nitrous oxide on autonomic function in children
Region
| Japan |
Condition
Condition
anesthetized children
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nitrous oxide as a sole agent works sympathlytically in children. Contrarily, sevoflurane works sympathmemetically in children. the combination of the two anesthetics are commonly used for the anesthetic induction in children.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Variables obtained by the frequency-domain analysis of the heart rate variablity; the power of low frequency component (0.04 - 0.15 Hz, LF), the power of high frequency component (0.15 - 0.5 Hz, HF), and the ratio LF/HF
Key secondary outcomes
mean blood pressure, heart rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
N2O group. Anesthesia is induced using slowly-incremental doses of sevoflurane up to 5% in a gas mixture of nitrous oxide 4 l/min + oxygen 2 l/min. Once the complete loss of consciousness is obtained, sevoflurane concentration is set at 2% and a venous route is secured. Pressure-controlled mechanical ventilation with a rate of 20/min is initiated and the peak inspiratory pressure is adjusted to maintain the end-tidal CO2 tension within 35 - 45 mmHg. The anesthesia and ventilation conditions are maintained, and blood pressure is measured every 1 min for 5 min (induction period, ID). Following ID, mechanical ventilation with O2 6 l/min +sevofurane 3% is started. After 1 min, laryngeal mask insertion or oro-tracheal intubation is performed. During surgery, anesthesia is mantained using the gas mixture of O2 1.5 l/min + air 4.5 /min + maintenance concentrations of sevoflurane. a small amount of fentanyl and/or peripheral nerve blocks are supplemented before the start of surgery as appropriate for the type of surgery. Svoflurane inspired concentration is reduced to 1.2% 5 min before the end of surgery and maintained for 3 min after the end of surgery. Blood pressure is measured every 1 min for the last 3 min (control period, Control). After the control period, The administration of sevoflurane is terminated, and the patients are ventilated with 100% O2 until the patients get emergence from anesthesia as a usual anesthesia arousal procedure.
Interventions/Control_2
O2 group. Anesthesia is induced using slowly-incremental doses of sevoflurane up to 7% in oxygen 6 l/min. Once the complete loss of consciousness is obtained, sevoflurane concentration is set at 2.5%. As in the N2O (intervention 1) group, venous route acquisition, the mechanical ventilation, and the five-min data collection are followed. Thereafter, the maintenance of anesthesia, postoperative data collection, and anesthesia arousal procedure are conducted same as in the N2O group.
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
| 2 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects whose ages are equal to or older than 2 years old and younger than 7 years old.
2) Subjects who are planned to undergo minor surface surgery under general anesthesia such as inguinal hernia repair, orchidopexy, resection of fistula auris congenita, nevus resection, and laser diathermy of nevus pigmentosus
3) Subjects who do not suffer any systemic disease such as cardiovascular, respiratory, endocrine or metabolic diseases.
4) Subjects (the guardians) who give written informed consent
Key exclusion criteria
1) Subjects who undergo emergency or sub-emergency surgery.
2) Subjects who suffer acute illnesses such as infectious diseases even after the approval from the guardians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Sato |
Organization
Tokyo Women's Medical University, Yachiyo Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Owada-Sinden 477-96, Yachiyo, Chiba, 276-8524, Japan
TEL
047-450-6000
sato.jiro@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Sato |
Organization
Tokyo Women's Medical University, Yachiyo Medical Center
Division name
Department of Anesthesiology
Zip code
Address
Owada-Sinden 477-96, Yachiyo, Chiba, 276-8524, Japan
TEL
047-450-6000
Homepage URL
sato.jiro@nifty.com
Sponsor or person
Institute
Tokyo Women's Medical University
Yachiyo Medical Center
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Yachiyo Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
東京女子医科大学八千代医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | 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
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023127
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| Registered date | File name |
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| Registered date | File name |
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