UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bispectral index values during general anesthesia in children.
Title of the study (Brief title)	Bispectral index values and premedication in children.
Region	Japan

Condition
Condition	Pediatric patients scheduled for elective surgery under general anesthesia.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the end-tidal sevoflurane concentration for Bispectral Index 50 of children with clonidine as premedication and that of children without premedication.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The end-tidal sevoflurane concentration for maintaining Bispectral Index 50.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	2 years-old <=
Age-upper limit	4 years-old >=
Gender	Male and Female
Key inclusion criteria	Pediatric patients with written informed parental concent, ASA I and II, aged 2 to 4 years, and scheduled for elective surgery under general anesthesia.
Key exclusion criteria	severe heart and lung disease, psychic and nervous disease,abnormal ECG, obesity with BMI >30 kg.m-2, other sedative medication, expected difficult airway management.
Target sample size	70

Research contact person
Name of lead principal investigator	Junko TOKUWAKA
Organization	University of Tsukuba Hospital
Division name	Department of anesthesiology
Address	Amakubo 2 chome 1-1, Tsukuba City, Ibaraki
TEL	029-896-7357
Email	tokuwaka-tuk@umin.ac.jp

Public contact
Name of contact person	Junko TOKUWAKA
Organization	University of Tsukuba Hospital
Division name	Department of anesthesiology
Address	Amakubo 2 chome 1-1, Tsukuba City, Ibaraki
TEL	029-896-7357
Homepage URL
Email	tokuwaka-tuk@umin.ac.jp

Sponsor
Institute	Department of Anesthesiology, University of Tsukuba
Institute
Department

Funding Source
Organization	Department of Anesthesiology, University of Tsukuba
Organization
Division
Category of Funding Organization	Self funding
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 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 01 Day
Anticipated trial start date	2011 Year 03 Month 10 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	Partially published
URL releasing results
Results
Other related information	We record patients` premedication and BIS value after maintaining end-tidal sevoflurane concentration over 10 minutes. Then we evaluate end-tidal concentration of sevoflurane for BIS 50 using logistic analysis until we gain significant confidence interval.

Management information
Registered date	2018 Year 08 Month 01 Day
Last modified on	2018 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038304