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Comparison Effect of etomidate and propofol on delirium and dementia in elderly patients after orthopedic surgery at the hospital Ali ibn Abi Talib in Rafsanjan: a randomized, double-blind,

Protocol summary

Study aim
1- Determination of the effect of two anti-epileptic drugs and propofol on the delirium after surgery, by sex, age and time. 2. Determine the mean score of the dementia test (MMSE) based on sex, age and time 3. Determine the mean score of the Neecham test based on sex, age and time 4- Determination of the effect of two drugs and propofol on the patient's pain after anesthesia by gender, age and time.
Design
A concealed, randomized, blinded, drug controlled clinical trial with a parallel group design of 50 patients, enrolled between Jun 2018 and September 2019
Settings and conduct
In this study, elderly people over 60 years of age who suffered a bone fracture in 96 and 97 years and who were referred to Ali ibn Abi Talib Hospital in Rafsanjan and who were required to undergo general anesthesia surgery. Patients were randomly divided into two groups. Before starting anesthesia and during anesthesia, we monitored the vital signs of the patients. The amount of arterial oxygen saturation and blood pressure were measured every 5 minutes. After this stage, the hypnotic drug (Propofol control group - In-group autoimmunity) was given on the basis of patient weight.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having at least 60 years of age, orthopedic candidate Exclusion criteria: Alcoholism, history of mental disorders (MMSE score less than 23), history of stroke in 6 months before surgery, patient dissatisfaction.
Intervention groups
In the control group, Propofol (2 mg per kg body weight) (manufacturer B, Brun melsungen AG Germany) was used to sleep, and in the Intervention group, an autoantibody (0.2 mg per dose) Kg body weight (manufacturer Janssen-Cilag2012) is used for sleeping.
Main outcome variables
pain- Dementia-Delirium

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181206041866N1
Registration date: 2019-01-29, 1397/11/09
Registration timing: retrospective

Last update: 2019-01-29, 1397/11/09
Update count: 0
Registration date
2019-01-29, 1397/11/09
Registrant information
Name
Hossein Ghavipaykar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 6000
Email address
ghavipeykar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-13, 1396/10/23
Expected recruitment end date
2018-09-13, 1397/06/22
Actual recruitment start date
2018-01-13, 1396/10/23
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2018-10-13, 1397/07/21
Scientific title
Comparison Effect of etomidate and propofol on delirium and dementia in elderly patients after orthopedic surgery at the hospital Ali ibn Abi Talib in Rafsanjan: a randomized, double-blind,
Public title
etomidate and propofol on delirium and dementia in elderly patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Senior citizens over the age of 60 who are candidates for orthopedic surgery Class 1 and ASA class 1 disease Candidate for orthopedic surgery
Exclusion criteria:
Alcohol addiction History of mental disorders (MMSE score less than 23) History of myocardial infarction in 6 months before surgery Patient dissatisfaction
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The patient chooses a sealed envelope in random order
Blinding (investigator's opinion)
Double blinded
Blinding description
All staff involved with the patient in the process include nurses and health professionals A person who measures the status of the patient's consequences is also blinded The patient himself does not know about the drug
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR. Rums. REC. 1396.206

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
F45.41
ICD-10 code description
Pain disorder exclusively related to psychological factors

2

Description of health condition studied
Dementia
ICD-10 code
F01.51
ICD-10 code description
Vascular dementia with behavioral disturbance

3

Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition

Primary outcomes

1

Description
pain
Timepoint
one day - 3 day after operation
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Dementia
Timepoint
one and 3 day after operation
Method of measurement
The Mini–Mental State Examination

2

Description
Delirium
Timepoint
One and 3 day after operation
Method of measurement
The NEECHAM Confusion Scale

Intervention groups

1

Description
Intervention group: It is an intravaginal anesthetic drug for induction of anesthesia or sedation that can be used for a short therapeutic course, such as insertion of shoulder joint or tracheal intubation. Its metabolism is essentially carried out with steroid hydrolysis to inactive metabolites, which are then excreted in urine and bile. The duration of the effect period is linearly dependent on the dose, which results in anesthesia with about 0.1 mg / kg per 100 seconds.
Category
Treatment - Drugs

2

Description
Control group: Propofol is a drug from the family of alkaline phenols, which was discovered in the 1970s. Propofol is used in general anesthesia for induction of anesthesia and maintenance of anesthesia in the intensive care unit, and an outpatient outpatient treatment is used in adults with a dose of 1.5-5.5mg / kg / 1 intravenously. Also, side effects of the medicine include the treatment of cholestasis and stroke epilepsy.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Hossein Ghavipeykar
Street address
Iman Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0000
Email
aliebn@rums.ac.ir
Web page address
https://aliebn.rums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3131 5075
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hossein Ghavipeykar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
dr.ghavipaykar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Pakzad
Position
Aneshtiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
EMAM ALI
City
RAFSANJAN
Province
Kerman
Postal code
7716614697
Phone
+98 343428000
Email
Pakzadmoghadam@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hossein Ghavipeykar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
dr.ghavipaykar@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document
There is no further information
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