UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bispectral index values during general anesthesia using desflurane.
Title of the study (Brief title)	The relationship between bispectral index values and age.
Region	Japan

Condition
Condition	Patients scheduled for surgical treatment under general anesthesia.
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the minimum alveolar desflurane concentration for maintaining the BIS below 50 in adults and children.
Basic objectives2	Others
Basic objectives -Others	A BIS target below 50 is considered appropriate for maintaining unconsciousness during general anesthesia.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The end-tidal desflurane concentration for maintaining the BIS below 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	5 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with written informed consent, American Society of Anesthesiologists (ASA) physical status I and II, aged 5 to 90 years, and scheduled for elective surgery under general anesthesia.
Key exclusion criteria	A history of cardiovascular, respiratory or psychological diseases, abnormal electrocardiogram (ECG), obesity with BMI > 30 kg.m-2, expected difficult airway management, and parental request for premedication.
Target sample size	120

Research contact person
Name of lead principal investigator	Tsuyoshi Satsumae
Organization	University of Tsukuba
Division name	Department of Anesthesiology
Address	Tennodai 1-1-1, Tsukuba City, Ibaraki
TEL	029-853-3092
Email	tsuu@md.tsukuba.ac.jp

Public contact
Name of contact person	Tsuyoshi Satsumae
Organization	University of Tsukuba
Division name	Department of Anesthesiology
Address	Tennodai 1-1-1, Tsukuba City, Ibaraki
TEL	029-853-3092
Homepage URL
Email	tsuu@md.tsukuba.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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 15 Day
Anticipated trial start date	2014 Year 08 Month 05 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	The minimum alveolar concentration of desflurane was calculated to be 4.17%, 3.53%, 3.33% in the 10-19 year-old, 20-39 year-old, and 40-69 year-old group, respectively. The minimum alveolar concentration of desflurane decreases with advance in age (P = 0.007).
Other related information	Research design: cross-sectional study Way for subscription of patients: patients who were scheduled for elective surgery under general anesthesia after institutional review board approval and written informed consent from August 2014 Measurement parameters: heart rate, blood pressure, SPO2, BIS values, end-tidal CO2 concentration

Management information
Registered date	2015 Year 12 Month 07 Day
Last modified on	2017 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023181