UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of remifentanil on emergence agitation after desflurane anesthesia
Title of the study (Brief title)	The effect of remifentanil on emergence agitation
Region	Japan

Condition
Condition	Patients undergoing surgery for thyroid disease
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate whether remifentanil can attenuate the degree of emergence agitation after desflurane anesthesia, compared with the historical control without remifentanil administration
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The degree of emergence agitation evaluated by the modified pediatric anesthesia emergence delirium scale
Key secondary outcomes	Time to extubation Visual analogue scale Postoperative nausea and vomotting

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients undergoing operation for throid diseases
Key exclusion criteria	Patients with GCS equal to or less than 14, psychiatry diseases, mental retardation, or obesity with BMI>35
Target sample size	60

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 160-8582 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 160-8582 Japan
TEL	03-3353-1211
Homepage URL
Email	takeshi-su@a7.keio.jp

Sponsor
Institute	Ito Hospital
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Keio University School of Medicine
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	2015 Year 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 07 Month 01 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	Patients, who met the inclusion criteria, underwent operation under general anesthesia with desflurane and remifentanil. Emergence agitation was evaluated using the scoring system after operation and before extubation. Time to extubation, VAS and PONV were also recorded. These measurements were compared with those of historical control which didn't receive remifentanil adminostration.

Management information
Registered date	2015 Year 11 Month 08 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=R000022751