UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034634 |
|---|---|
| Receipt number | R000039443 |
| Scientific Title | Effects of perioperative administration of synthetic steroid on glycometabolism and insulin resistance |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2021/07/02 15:00:43 |
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Basic information
Public title
Effects of perioperative administration of synthetic steroid on glycometabolism and insulin resistance
Acronym
Effects of perioperative administration of synthetic steroid on glycometabolism and insulin resistance
Scientific Title
Effects of perioperative administration of synthetic steroid on glycometabolism and insulin resistance
Scientific Title:Acronym
Effects of perioperative administration of synthetic steroid on glycometabolism and insulin resistance
Region
| Japan |
Condition
Condition
preoperative management for oral, maxirofacial surgery and dental surgery
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study effects of administration of synthetic steroid during general anesthesia on postoperative hyperglycemia and insuline resistance
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative Insulin Resistance
Key secondary outcomes
change of blood glucose nduring general anesthesia, blood test (lactate, free fatty acid,ketone body, catecholamine, 3-methylhistidine(indicator of muscle protein degradation,cortisol), serum electrolyte(Na+,K,Mg2+,Ca2+,Cl-),arterial blood gas (pH,PaCO2,PaO2,HCO3-,BE),urine glucose, urea nitrogen
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Synthetic steroid
Interventions/Control_2
Normal saline
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
written informed concent is obtained from patients who undergo oral surgery
aged from 20 to 50
ASA from 1 or 2
estimated operation time:3-7 hours
Key exclusion criteria
patients diagnosed with diabetes mellitus or disorder of carbohydrate metabolism
18.0>BMI BMI<=30
patients to who should not receive rinderon
patients whom reseachers consider inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaori Tsukamoto |
Organization
Kyushu University Hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926426480
tsukamoto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayuri Kadowaki |
Organization
Kyushu University Hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926426480
Homepage URL
s.koyama@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Nikkiso Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
YES
Study ID_1
29049
Org. issuing International ID_1
Kyushu University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039443
