UMIN-CTR Clinical Trial

Basic information
Public title	The accuracy of surgical pleth index (SPI) according to nicardipine or remifentanil intravenous infusion by comparing numerical changes of SPI value and end-tidal desflurane concentration during thyroid surgery: a prospective, single-centered, randomized , double-blind study.
Acronym	The accuracy of surgical pleth index (SPI) according to nicardipine or remifentanil intravenous infusion by comparing numerical changes of SPI value and end-tidal desflurane concentration
Scientific Title	The accuracy of surgical pleth index (SPI) according to nicardipine or remifentanil intravenous infusion by comparing numerical changes of SPI value and end-tidal desflurane concentration during thyroid surgery: a prospective, single-centered, randomized , double-blind study.
Scientific Title:Acronym	The accuracy of surgical pleth index (SPI) according to nicardipine or remifentanil intravenous infusion by comparing numerical changes of SPI value and end-tidal desflurane concentration
Region	Asia(except Japan)

Condition
Condition	Patients who are undergoing elective thyroidectomy
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The accuracy of surgical pleth index (SPI) according to nicardipine or remifentanil intravenous infusion by comparing numerical changes of SPI value and end-tidal desflurane concentration
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes of SPI value during general anesthesia, change of desflurane concentration, hemodynamic change, recovery profiles and postoperative pain, analgesic requirement in adult whose age are from 20 to 65.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	remifentanil 50ug bolus administration before skin incision, than administation remifentanil infusion 0.02ug/kg/min and titrate by 0.01ug/kg/min to maintaine mean arterial pressure between baseline MBP 20%
Interventions/Control_2	nicardipine 100ug bolus administration before skin incision, than administation nicardipine infusion 0.5ug/kg/min and titrate by 0.1ug/kg/min to maintaine mean arterial pressure between baseline 20%
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients aged 20-65 years with a physical status of 1 (the American Society of Anesthesiologists rating) who are scheduled to undergo elective thyroidectomy
Key exclusion criteria	Patients with a history of cardiovascular, respiratory (asthma), neurologic (seizure), kidney, liver disease, mood disorder, prematurity, or developmental delay, the presence of upper respiratory infection, hypersensitivity to drugs, and those receiving analgesics, sedatives or psychiatric medication will be excluded.
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Middle name Last name Young ju Won
Organization	Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82-2-2626-1437
Email	moma2@naver.com

Public contact
Name of contact person	1st name Middle name Last name Young ju Won
Organization	Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82226261437
Homepage URL
Email	moma2@naver.com

Sponsor
Institute	Korea University
Institute
Department

Funding Source
Organization	Korea University
Organization
Division
Category of Funding Organization	Outside Japan
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

Other administrative information
Date of disclosure of the study information	2016 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	2015 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2016 Year 12 Month 08 Day
Date of closure to data entry	2016 Year 12 Month 10 Day
Date trial data considered complete	2016 Year 12 Month 10 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 09 Month 17 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022028

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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