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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015683
Receipt No. R000018135
Scientific Title The comparison of the indicator of oxycodone administration during thyroidectomy operation: surgical pleth index versus conventional vital sign
Date of disclosure of the study information 2015/08/11
Last modified on 2015/08/11

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Basic information
Public title The comparison of the indicator of oxycodone administration during thyroidectomy operation: surgical pleth index versus conventional vital sign
Acronym The comparison of the indicator of oxycodone administration during thyroidectomy
Scientific Title The comparison of the indicator of oxycodone administration during thyroidectomy operation: surgical pleth index versus conventional vital sign
Scientific Title:Acronym The comparison of the indicator of oxycodone administration during thyroidectomy
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 The aims of this study are to evaluate the effectiveness of surgical pleth index-guided analgesia compared with conventional practice analgesia in the aspects of intraoperative anesthetic and analgesic requirement, hemodynamic change, recovery profiles and postoperative pain, analgesic requirement in adult whose age are from 20 to 65.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intraoperative analgesic requirement
Key secondary outcomes Intraoperative anesthetic consumption, hemodynamics, recovery profiles, and postoperative pain, analgesic requirement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intravenous oxycodone 1mg will be administered when surgical pleth index (SPI) value is above 50 in SPI group for 1 min. Time intervalof administration is minimum 5min .
Interventions/Control_2 Intravenous oxycodone 1mg will be administered when blood pressure or heart rate is increased to above 20% of the baseline value in control group for 1 min. Time intervalof administration is minimum 5min .
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 92

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 82-2-2626-1437
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
2015 Year 08 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2014 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
2015 Year 03 Month 13 Day
Date trial data considered complete
2015 Year 03 Month 16 Day
Date analysis concluded
2015 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 11 Month 13 Day
Last modified on
2015 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018135

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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