UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the difference of emergence agitation between sevoflurane and desflurane anesthesia with remifentanil
Title of the study (Brief title)	The effect of volatile anesthetics on emergence agitation
Region	Japan

Condition
Condition	thyroid diseases
Classification by specialty	Endocrine surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the degree of emergence agitation between sevoflurane and desflurane anesthesia with remifentanil
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The degree of emergence agitation evaluated by modified pediatric anesthesia emergence delirium (PAED) scale
Key secondary outcomes	Time to extubation Post-operative pain evaluated by numerical rating scale Postoperative nausea and vomiting

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Sevoflurane anesthesia with remifentanil
Interventions/Control_2	Desflurane anesthesia with remifentanil
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients equal to or more than 20 years old who undergo operation under general anesthesia for thyroid diseases
Key exclusion criteria	Patients with body mass index more than 35 Patients with psychiatric disorder Patients contraindicated against suxamethonium
Target sample size	150

Research contact person
Name of lead principal investigator	Takeshi Suzuki
Organization	Keio University School of Medicine
Division name	Anesthesiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	takeshi-su@a7.keio.jp

Public contact
Name of contact person	Takeshi Suzuki
Organization	Keio University School of Medicine
Division name	Anesthesiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	takeshi-su@a7.keio.jp

Sponsor
Institute	Department of Anesthesiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Self funding
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	2016 Year 09 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 26 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	2016 Year 09 Month 17 Day
Last modified on	2018 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027739