UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039750 |
|---|---|
| Receipt number | R000045258 |
| Scientific Title | Changes in heart rate caused by nitrous oxide during general anesthesia |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2020/03/09 20:19:30 |
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Basic information
Public title
Changes in heart rate caused by nitrous oxide during general anesthesia
Acronym
Changes in heart rate caused by nitrous oxide
Scientific Title
Changes in heart rate caused by nitrous oxide during general anesthesia
Scientific Title:Acronym
Changes in heart rate caused by nitrous oxide
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of nitrous oxide on heart rate during general anesthesia
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the heart rate from the control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group is administrated nitrous oxide for 15 minutes in each case. FiO2 is 0.3.
Interventions/Control_2
Control group is administrated air mixed oxygen for 15 minutes in each case. FiO2 is 0.3.
Interventions/Control_3
If the heart rate in the intervantion group (nitrous oxide, FiO2 0.3) significantly decrease compared with that in the control group, we will investigate the effect of nitrous oxide, FiO2 0.65 on the heart rate.
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 general anesthesia using inhalational anesthetics combined epidural anesthesia
2. Supine position,
3. ASA-PS1,2
4. Intubated cuffed tracheal tube
5. scheduled urological operation of over 150 minutes
Key exclusion criteria
1. Past history of cardiac,respiratory,or neuromuscular disease affecting respiratory function
2. Upper respiratory infection
3. non-scheduled operation
4. allergy of anesthetics
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomonari |
| Middle name | |
| Last name | Shinozaki |
Organization
Miyagi Children's Hospital
Division name
Department of Anesthesiology
Zip code
989-3126
Address
4-3-17 Ochiai, Aoba, Sendai, Miyagi
TEL
0223915111
shinozaki-t@miyagi-children.or.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nakai |
Organization
Miyagi Children's Hospital
Division name
Clinical Research Center
Zip code
989-3126
Address
4-3-17Ochiai,Aoba,Sendai,Miyagi
TEL
0223915111
Homepage URL
kei.nakai@miyagi-children.or.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
Miyagi Children's Hospital
Address
4-3-17 Ochiai, Aoba, Sendai, Miyagi
Tel
0223915111
shinozaki-t@miyagi-children.or.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
| 2020 | Year | 03 | Month | 10 | 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
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045258
