UMIN-CTR Clinical Trial

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