UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019058 |
|---|---|
| Receipt number | 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 09:26:44 |
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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
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
moma2@naver.com
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022028
