UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010013 |
|---|---|
| Receipt number | R000011718 |
| Scientific Title | Autonomic nervous influence of inhalational anesthetic desflurane |
| Date of disclosure of the study information | 2013/02/13 |
| Last modified on | 2013/02/10 13:01:25 |
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Basic information
Public title
Autonomic nervous influence of inhalational anesthetic desflurane
Acronym
Autonomic nervous influence of desflurane
Scientific Title
Autonomic nervous influence of inhalational anesthetic desflurane
Scientific Title:Acronym
Autonomic nervous influence of desflurane
Region
| Japan |
Condition
Condition
Patients who undergo general anesthesia by desflurane
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of desflurane to the sympathetic and parasympathetic nervous systems
Basic objectives2
Others
Basic objectives -Others
To investigate effects of desflurane to the sympathetic and parasympathetic nervous systems using heart rate variability
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Low and high frequency before induction of general anesthesia, during induction and during emergence
Key secondary outcomes
Blood pressure and heart rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Desflurane 3%
During general anesthesia
Interventions/Control_2
Desflurane 6%
During general anesthesia
Interventions/Control_3
Desflurane 9%
During general anesthesia
Interventions/Control_4
Sevoflurane 2%
During general anesthesia
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS(American Society of Anesthesiologists - Physical Status) 1~3
Key exclusion criteria
(a) Patients with IHD
(b) Patient with COPD
(c) Renal or/and hepatic dysfunction
(d) Obesity (BMI > 35)
(e) Drug or/and alcohol abuse
(f) Anemia (Ht < 25%)
(g) Past or/and family history of malignant hyperthermia
(h) Patient who underwent general anesthesia within 7 days
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Hirata |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Chuo-ku S-1 W-17 291, Sapporo, Hokkaido
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
Chuo-ku S-1 W-17 291, Sapporo, Hokkaido
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
札幌医科大学附属病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 12 | Day |
Last modified on
| 2013 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011718
