UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006778
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Obsterics 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
Email

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
Email

Sponsor
Institute Secretariat of postoperative delirium studies
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008022

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.