UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019058
Receipt No. R000022028
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.
Date of disclosure of the study information 2016/02/01
Last modified on 2017/07/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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://upload.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


Contact us.