We have studied the influence of using BIS index (Bispectral index) in recovery of elderly patients undergoing abdominal surgery anaesthetized with isoflurane. This study was designed to investigate whether BIS monitoring improves clinical anesthetic delivery, recovery profiles in elderly patients undergoing abdominal surgery with general anesthesia compared to standard clinical practice (without monitoring) . The study group included 68 patients having American Society of Anesthesiologists (ASA) physical status of I to III who were scheduled for elective abdominal surgery. Patients were randomly allocated into two groups that receiving general anesthesia with BIS monitoring and without using of BIS. Inclusion criteria were abdominal surgery, ASA ( American Society of Anesthesiologists ) physical status of I to III, over the age of 60 and exclusion criteria were a history of psychotic disorders, dementia, previous CVA (cerebrovascular accident), head trauma, and drug abuse . In both groups standard monitoring was used, including BIS recording via two bipolar electroencephalographic leads. The main outcome is recovery time and discharge from recovery.
General information
Acronym
BIS monitoring
IRCT registration information
IRCT registration number:IRCT201101121481N1
Registration date:2011-05-10, 1390/02/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-10, 1390/02/20
Registrant information
Name
Amir Asadi
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1828 1440
Email address
asadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences and Health Services
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Use of Isoflurane with depth anesthesia monitoring (Bispecteral Index) and its effect on the recovery of elderly patients
Public title
Use of Isoflurane with depth anesthesia monitoring (Bispecteral Index) and its effect on the recovery of elderly patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: elderly patients with grade ASA (American Society of Anesthesiologists) I to III, have over 60 years of age for the intra-abdominal surgery (Cholecystectomy, ...). Exclusion Criteria: Psychotic disorders, Dementia, Previous CVA, Head trauma, and Drug abuse.
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences and Health Services
Street address
Hamedan University of Medical Sciences and Health Services
City
Hamedan
Postal code
8736-3-65178
Approval date
2008-07-26, 1387/05/05
Ethics committee reference number
56581/9/35/16/پ
Health conditions studied
1
Description of health condition studied
general anesthesia
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Measuring Depth of Anesthesia
Timepoint
Continuously during surgery
Method of measurement
By bipolar electroencephalographic leads that connected to the temporal and frontal area of patients and brain waves evaluated by BIS monitoring according to numbers from 0 to 100.
Secondary outcomes
1
Description
awakening and discharge from recovery
Timepoint
awakening time and discharge from recovery
Method of measurement
According to Alderet Score
Intervention groups
1
Description
A: Standard practice (control group): receive general anesthesia and administration of anesthesia drugs was performed according to patients clinical evaluation in during surgery.
Category
Other
2
Description
B: BIS Group (test group): receive general anesthesia and administration of anesthesia drugs was performed according to BIS monitoring guided titration in during surgery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Amir Asadi
Street address
Besat Hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research , Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ali Ghaleiha
Street address
Vice chancellory for Research, Hamedan University of Medical Sciences and Health Services
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research , Hamedan University of Medical Sciences and Health Services
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
Vice chancellor for research , Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Dr. Ali Ghaleiha
Position
Associate Professor
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences and Health Services
City
Hamedan
Postal code
Phone
+98 81 1827 6296
Fax
Email
ghaleiha@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Amir Asadi
Position
M.sc
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences and Health Services
City
Hamedan
Postal code
Phone
+98 81 1828 1440
Fax
Email
asdadi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences and Health Services
Full name of responsible person
Amir Asadi
Position
M.sc
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences and Health Services
City
Hamedan
Postal code
65178-3-8736
Phone
+98 81 1828 1440
Fax
+98 81 1828 1442
Email
asadi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)