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


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 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


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

Value
https://center6.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