UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009933
Receipt number R000011637
Scientific Title Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants: evaluation by heart rate variability
Date of disclosure of the study information 2013/02/01
Last modified on 2018/08/29 11:34:17

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Basic information

Public title

Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants: evaluation by heart rate variability

Acronym

Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants

Scientific Title

Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants: evaluation by heart rate variability

Scientific Title:Acronym

Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants

Region

Japan


Condition

Condition

cleft lip

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the optimal sevoflurane concentration that would minimize changes in the hemodynamics and autonomic nervous activity during intubation using heart rate variability in infants.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

heart rate, blood pressure, heart rate variability

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are 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

sevoflurane 3%

Interventions/Control_2

sevoflurane 4%

Interventions/Control_3

sevoflurane 5%

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


Not applicable

Age-upper limit

6 months-old >=

Gender

Male and Female

Key inclusion criteria

cleft lip patients aged under 6 months old with an American Society of Anesthesiologists physical status of 1 or 2 who were undergoing general anesthesia for elective cheiloplasty.

Key exclusion criteria

A history of epilepsy or significant cardiopulmonary, renal, or hepatic dysfunction, symptoms of an upper respiratory tract infection, or predictive signs of difficult intubation

Target sample size

68


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Hanamoto

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Dental Anesthsiology

Zip code


Address

1-8, Yamadaoka, Suita, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Dental Anesthsiology

Zip code


Address

1-8, Yamadaoka, Suita, Osaka, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Osaka University Graduate School of Dentistry

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

大阪大学歯学部附属病院


Other administrative information

Date of disclosure of the study information

2013 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2010 Year 11 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 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

2013 Year 02 Month 01 Day

Last modified on

2018 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011637


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name