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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039750
Receipt No. 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

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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
Email 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
Email kei.nakai@miyagi-children.or.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 Miyagi Children's Hospital
Address 4-3-17 Ochiai, Aoba, Sendai, Miyagi
Tel 0223915111
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045258

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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