Comparison of the effect of sedation by Propofol and Midazolam on cognitive performance in patients older than 65 years candidate for Hip surgery undergoing spinal anesthesia: double blind clinical trial
Comparison of the effect of sedation by Propofol and Midazolam on cognitive performance in patients older than 65 years candidate for hip surgery undergoing spinal anesthesia: double blind clinical trial
Design
136 Patients over 65 years old candidate for hip surgery undergoing spinal anesthesia will be in double blind randomized clinical trial. in one of the two intravenous administration of 0.2 mg/kg Propofol and 0.02 mg/kg Midazolam.
Settings and conduct
In this study, patients older than 65 years candidate for hip surgery undergoing spinal anesthesia cwho will be referred to the Besat Hospital of Hamadan during the study period, will be randomly assigned to randomized allocation blocks by random sampling.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: patients older than 65 years; Patients with ASA class 1 and 2; Patients candidate for Hip surgery undergoing spinal anesthesia.
Exclusion Criteria:Failure to spinal anesthesia and general anesthesia; Patients with history of alcohol and drug use, sedation and anticonvulsants; History sensitivity to anesthetic drugs; History of cognitive impairment; Spinal anesthesia contraindications
Intervention groups
Intervention group 1: The amount of 0.2 mg/kg Propofol intravenously after spinal anesthesia by an anesthesiologist injected intravenously.
2 intervention groups: the amount of 0.02 mg/kg Midazolam after spinal anesthesia by an anesthesiologist injected intravenously.
Main outcome variables
The percentage of people who have Mini Mental State Examination scores less than 20 after spinal anesthesia and taking Propofol or Midazolam.
Systolic and Diastolic Blood Pressure, Nausea & vomiting, Heart Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120915010841N19
Registration date:2019-07-01, 1398/04/10
Registration timing:registered_while_recruiting
Last update:2019-07-01, 1398/04/10
Update count:0
Registration date
2019-07-01, 1398/04/10
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-21, 1397/12/02
Expected recruitment end date
2021-02-20, 1399/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sedation by Propofol and Midazolam on cognitive performance in patients older than 65 years candidate for Hip surgery undergoing spinal anesthesia: double blind clinical trial
Public title
Effect of sedation by propofol and midazolam on cognitive performance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 65 years
Patients with ASA class 1 and 2
Patients candidate for hip surgery undergoing spinal anesthesia
Exclusion criteria:
Failure to spinal anesthesia and general anesthesia
Patients with history of alcohol and drug use, sedation and anticonvulsants
History sensitivity to anesthetic drugs
History of cognitive impairment
Spinal anesthesia contraindications
Age
From 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and, According to the text, the patient is given one of two groups: A (Propofol) and B (Midazolam). Then, for four subsequent patients, the paper is returned to the bag again, and this process is repeated until the end of the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
In both groups A and B, medications after spinal anesthesia one of two drugs (Propofol or Midazolam) will be prescribed.In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.UMSHA.REC.1397.966
Health conditions studied
1
Description of health condition studied
Cognitive disorders following hip surgery under spinal anesthesia
ICD-10 code
G31.1
ICD-10 code description
Senile degeneration of brain, not elsewhere classified
Primary outcomes
1
Description
The percentage of people who have Mini Mental State Examination scores less than 20 after spinal anesthesia and taking Propofol or Midazolam.
Timepoint
The day before surgery and before discharging from the hospital
Method of measurement
Using Mini Mental State Examination questionnaire
Secondary outcomes
1
Description
Nausea & vomiting
Timepoint
After surgery
Method of measurement
Observation
2
Description
Systolic and Diastolic Blood Pressure
Timepoint
Every three minutes to 20 minutes and then every 10 minutes until the end of the surgery
Method of measurement
Non-invasive automatic barometric device
3
Description
Heart Rate
Timepoint
Every three minutes to 20 minutes and then every 10 minutes until the end of the surgery
Method of measurement
Using a pulse oximeter
Intervention groups
1
Description
First Intervention group : The amount of 0.2 mg/kg Propofol 1%(10mg/ml and made by B.BRAUN company in Germany), is injected intravenously after spinal anesthesia by anesthesiologist.
Category
Treatment - Drugs
2
Description
Second Intervention group: The amount of 0.02 mg/kg Midazolam(1mg/ml and made by Caspian pharmaceutical company in Iran), is injected intravenously after spinal anesthesia by anesthesiologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Besat Hospital in Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.besat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 918 111 0366
Email
manuchehriann@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available