UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006778 |
|---|---|
| Receipt number | R000008022 |
| Scientific Title | Studies of the relationship between anesthetic and postoperative delirium |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2013/03/26 12:40:04 |
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Basic information
Public title
Studies of the relationship between anesthetic and postoperative delirium
Acronym
Studies of the relationship between anesthetic and postoperative delirium
Scientific Title
Studies of the relationship between anesthetic and postoperative delirium
Scientific Title:Acronym
Studies of the relationship between anesthetic and postoperative delirium
Region
| Japan |
Condition
Condition
Thoracic,abdominal,spinal disease
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Obstetrics and Gynecology | Orthopedics |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Anesthetic management in the elderly, the use remifentanil, the impact of postoperative delirium and serum melatonin
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum melatonin concentrations
The incidence rate of delirium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2011.12-2014.3
Remifentanil group 18patients
The remifentanil used during anesthesia
with sevoflurane
Remifrntanil infusion 0.25-0.1microgram/kg/min
Blood pressure, heart rate, can be administered as 80-120% of control in the previous anesthesia
Interventions/Control_2
2011.12-2014.3
Fentanyl group 18patients
The fenanyl used during anesthesia with sevoflurane
Fentanyl intravenous 0.5-1maicrogram/kg/min
Blood pressure, heart rate, can be administered as 80-120% of control in the previous anesthesia
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients undergoing surgical surgery scheduled at least five hours and they are obtained approval from their doctor
2) Patients will admitted to intensive care after surgery and Patients are extubated
3) Once Upon receiving a full explanation of the study participants,
And over full understanding, patient consent was obtained in writing by the patient's own free will
Key exclusion criteria
1)Japan coma scale 10-300
2) Mental illness, alcoholism patients,
Patients with drug dependence
3) Patients with dementia
4) Patients with sleep disorders
5) The principal investigator,
Patients deemed unsuitable as subjects
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mishiya Matsumoto |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of anesthesiology
Zip code
Address
1-1-1 minamikogushi,ube-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Secretariat of postoperative delirium studies
Division name
Yamaguchi University Graduate School of Medicine Department of Anesthesiology
Zip code
Address
TEL
0836-22-2525
Homepage URL
Sponsor or person
Institute
Secretariat of postoperative delirium studies
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
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
| 2011 | Year | 12 | Month | 01 | 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
| 2011 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | 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
| 2011 | Year | 11 | Month | 27 | Day |
Last modified on
| 2013 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008022
