The effects of different doses of midazolam and preoperative anxiety on retrograde and anterograde amnesia in patients undergoing abdominal laparotomy under general anesthesia
The effects of different doses of midazolam and preoperative anxiety on retrograde and anterograde amnesia in patients undergoing abdominal laparotomy under general anesthesia
Design
120 patients aged 20 to 60 years at risk of ASA1-2 undergoing non-emergency abdominal laparotomy under GA at Rasoul Akram Hospital randomly assigned to, two groups with 60 persons a stressful or normal after the Amsterdam test Then, patients in each group are again divided into three groups of 20 each. This is performed by randomized block metod , Patients are divided into 3 blocks and 6 blocks in each blocks of the three groups are existed in study.the study is done with tripel metod and has a control group
Settings and conduct
In our study, 120 patients aged 20 to 60 years at risk of ASA1-2 undergoing non-emergency abdominal laparotomy under GA at Rasoul Akram Hospital were randomly assigned to two groups with 60 patients high -stress and Normal Then patients in each group were again divided into three groups of 20 each. To the first group midazolam As premed with dose of .02mg per kg and second one .04mg per kg will be injected. The third group will be the control group and will not receive midazolam. The registrant has no information about the type of drug.
Participants/Inclusion and exclusion criteria
Patients aged 20 to 60 years at risk of anesthesia 1 and 2 undergoing non-emergency abdominal laparotomy.Exclusion criteria included ASAIII risk, pregnant patients, patients with psychiatric disorders or taking sedative and antipsychotic medications, mental disorders, patients with visual or hearing impairment, patients with hepatic and renal impairment, and previous benzodiazepine use.
Intervention groups
The first group receive midazolam 02. mg / kg as premedication. The second group receive midazolam 04. mg / kg as premedication. Control group do not recieve Midazolam
Main outcome variables
Amnesia
General information
Reason for update
Acronym
The American Society of Anesthesiologists (ASA) (GA)general anesthesia SpO2 stands for peripheral capillary oxygen saturation blood pressure( BP
IRCT registration information
IRCT registration number:IRCT20200213046484N1
Registration date:2020-03-06, 1398/12/16
Registration timing:prospective
Last update:2020-03-06, 1398/12/16
Update count:0
Registration date
2020-03-06, 1398/12/16
Registrant information
Name
Saied Amniati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 0317
Email address
amniati.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of different doses of midazolam and preoperative anxiety on retrograde and anterograde amnesia in patients undergoing abdominal laparotomy under general anesthesia
Public title
The effect ofmidazolam and anxiety on amnesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
120 patients aged 20 to 60 years at risk of ASA1-2 undergoing non-emergency abdominal laparotomy undergoing GA at Rasool Akram Hospital
Exclusion criteria:
Patients with ASAIII risk
The Pregnant patient
Patients with psychiatric disorders or receiving sedative and antipsychotic medications
Mental dysfunction
Patients with visual or hearing impairment
Patients with liver and kidney dysfunction
Previous use of benzodiazepine
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In our study, 120 patients aged 20 to 60 years at risk of ASA1-2 undergoing non-emergency abdominal laparotomy undergoing GA at Rasoul Akram Hospital were randomly assigned to two groups of 60 high stress subjects after the Amsterdam test. And they will be normal. Then, patients in each group are again divided into three groups of 20 each. This is done by block randomization. Patients are divided into 3 and 6 blocks, each block having three study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient and the injector and the registrant are unaware of the type of study, and the study will be a Triple Blind study.
Placebo
Not used
Assignment
Factorial
Other design features
n our study, 120 patients aged 20 to 60 years at risk of ASA1-2 undergoing non-emergency abdominal laparotomy undergoing GA at Rasoul Akram Hospital were randomly assigned to two groups of 60 high stress subjects after the Amsterdam test. And they will be normal. Then the patients in each group are again divided into three groups of 20 each
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Rasoul Akram Hospital; Mansouri St; Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.IUMS.FMD.REC.1398.505
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Amnesia
Timepoint
Zero minutes (4 min before premedication), 2 (2 min before premedication), 4 (immediately before premedication) 6 min (2 min after premedication), 8 (4 min after Premedication) and 10 (6 min after premedication
Method of measurement
Cards with simple photos
Secondary outcomes
1
Description
Blood pressure
Timepoint
minutes 1,2,3 after intubation
Method of measurement
NIBP
2
Description
Heart rate
Timepoint
Minutes 1,2,5after intubation
Method of measurement
Monitoring device
3
Description
Decrease in oxygen saturation
Timepoint
Minutes 1,2,5after intubation
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Intervention group: : Midazolam .02mg / kg , One dose is injected as a premedication.
Category
Treatment - Drugs
2
Description
Intervention group: Midazolam .04mg / kg ,One dose is injected as a premedication.
Category
Treatment - Drugs
3
Description
Control group:do not take midazolam
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Azadeh Habibi
Street address
Rasoul Akram Hospital; Mansouri st; Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
azade_h84@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Azadeh Habibi
Street address
Rasoul Akram Hospital ; mansouri st ;Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 6435 2326
Fax
+98 21 6650 9059
Email
azade_h84@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Azadeh Habibi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram Hospital ; mansouri st ;Satarkhan Ave
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Personal information including patients 'age and sex ,anxiety and the effects of different doses of midazolam on amnesia and hemodynamic variables including blood pressure and heart rate may be disclosed if needed without disclosure and with ethical guidelines
When the data will become available and for how long
After publish of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The Current analysis in medical research subject to ethical standards in studies