UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in tidal volume caused by nitrous oxide during general anesthesia
Title of the study (Brief title)	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	Tomonari Shinozaki
Organization	Miyagi children's hospital
Division name	department of anesthesiology
Address	4-3-17, Ochiai, Aoba-ku Sendai-shi, Miyagi, Japan
TEL	022-391-5111
Email	tmn316@yahoo.co.jp

Public contact
Name of contact person	Tomonari Shinozaki
Organization	Miyagi children's hospital
Division name	department of anesthesiology
Address	4-3-17, Ochiai, Aoba-ku Sendai-shi, Miyagi, Japan
TEL	022-391-5111
Homepage URL
Email	tmn316@yahoo.co.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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035119