This study compared the effects of sevoflurane and propofol anesthesia on early cognitive function in patients 55 to 65 years old who are undergoing surgery should be done. A total of 60 patients (two groups of 30) 65 to 55 years, ASA class 2-1 have the characteristics of the study population are examined in this study.
Patients 12 hours before surgery in terms of cognitive function were assessed by MMSE test score is given. After infusion of the anesthetic propofol to maintain anesthesia in group 1 dose of 200-100 micrograms / kg / min is used.
The second group of patients with established Anesthesia sevofluran gas flow rate of 100% oxygen will 1MAC. 12 patients after -24-48 hours after surgery in terms of cognitive impairment with MMSE tests are evaluated and compared with before anesthesia 200-100 micrograms / kg / min in group 1. maintenance of anesthesia Patients in the second group would be sevofluran gas flow rate of 1MAC . the patients after 12 -24-48 hours after the operation are evaluated in terms of cognitive impairment with MMSE tests and compared with before anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102211209N1
Registration date:2013-02-02, 1391/11/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-02, 1391/11/14
Registrant information
Name
Parviz Kheirkhah
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1445 9802
Email address
parvizkheirkhah@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-10-29, 1391/08/08
Expected recruitment end date
2013-04-28, 1392/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Early cognitive function after Sevoflorane and Propofol anesthesia in 55-65 years old patients
Public title
Early cognitive function after Sevoflorane and Propofol anesthesia in 55-65 years old patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients needs elective abdominal Hernia surgery with ASA class 1 and 2 longed 1 to 4 hours.
exclusion criteria:patients with emergency surgery ; ASA class 3 and 4;history of known Psychology;History of cardiovascular disease;Stroke; High intracranial pressure; Traumatic brain injury in the past 12 months; Addiction to Alcohol; Substance Abuse; Sensitivity to anesthetic drugs And unwillingness to participate in the study
Age
From 55 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University Of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Approval date
2012-10-09, 1391/07/18
Ethics committee reference number
پ/29/5/1/2740
Health conditions studied
1
Description of health condition studied
Cognitive disorder
ICD-10 code
(F00-F99)
ICD-10 code description
disorders of psychological development
Primary outcomes
1
Description
Attention
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
2
Description
perception
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
3
Description
Speech
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
4
Description
Memory
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
5
Description
Learning
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
6
Description
Abstract thinking
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
Secondary outcomes
1
Description
Delirium
Timepoint
48-24-12 hours later, 12 hours before anesthesia
Method of measurement
MMSE TEST
Intervention groups
1
Description
Propofol 100-200 micrograms / kg / minute during the 1-3 hour surgery
Category
Treatment - Drugs
2
Description
During a 1-3 hour surgery with sevoflurane MAC1
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Parviz Kheirkhah
Street address
Beheshti Hospital,5th Kilometer Ghotbe Ravandi Bulv.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University Of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan University Of Medical Sciences, 5th Kilometer Ghotbe Ravandi Bulv
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan Univercity Of Medical Sciences
Full name of responsible person
Dr.Parviz Kheirkhah
Position
Resident in Anesthesiology
Other areas of specialty/work
Street address
Beheshti Hospital,5th Kilometer Ghotbe Ravandi Bulv.
City
Kashan
Postal code
Phone
+98 36 1533 0527
Fax
+98 36 1445 9697
Email
parvizkheirkhah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan Univercity Of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Fazel
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beheshti Hospital,5th Kilometer Ravand Bulv.
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
drmfazel@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan Univercity Of Medical Sciences
Full name of responsible person
Parviz Kheirkhah
Position
Resident in Anesthesiology
Other areas of specialty/work
Street address
Kashan Univercity Of Medical Sciences
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
+98 36 1445 9697
Email
parvizkheirkhah@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)