The effects of Dexmedetomidine and Midazolam on hemodynamic responses after tracheal intubation in elderly patients under Cataract surgery with general anesthesia in comparison to control group in Isfahan Feyz hospital from 2018-2019
The effects of Dexmedetomidine and Midazolam on hemodynamic responses after tracheal intubation in elderly patients under Cataract surgery with general anesthesia in comparison to control group
Design
Randomized double-blinded clinical trial study, Parallel groups with control groups on 195 patients, that randomization was centralized with Random Allocation software
Settings and conduct
The use of two different drugs with specific dose in two intervention groups and use of Normal Saline with the same volume in control group and comparing their effects on hemodynamic responses during tracheal intubation in Cataract surgery in Isfahan Feyz Hospital, that doctor and patient were unaware of the kind of medications
Participants/Inclusion and exclusion criteria
Conclusion criteria: Patients over 65 years old candidate for cataract surgery with general anesthesia with ASA2-3; No allergy to any of the study medications, Exclusion criteria: Hemodynamic changes over 30% that needed intervention; Patient who refusing; Severe drug complications; History of using opioid and alcohol; Changing the method of anesthesia; Severe chronic disease
Intervention groups
First intervention group patients receiving Dexmedetomidine; Second intervention group patients receiving Midazolam; Control group receiving Normal Saline with the same volume
Main outcome variables
Hemodynamic responses
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200510047389N2
Registration date:2020-05-19, 1399/02/30
Registration timing:retrospective
Last update:2020-05-19, 1399/02/30
Update count:0
Registration date
2020-05-19, 1399/02/30
Registrant information
Name
Amir Beidokhti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 3538
Email address
amir.beidokhti71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2018-11-22, 1397/09/01
Actual recruitment end date
2019-11-22, 1398/09/01
Trial completion date
2019-12-01, 1398/09/10
Scientific title
The effects of Dexmedetomidine and Midazolam on hemodynamic responses after tracheal intubation in elderly patients under Cataract surgery with general anesthesia in comparison to control group in Isfahan Feyz hospital from 2018-2019
Public title
The effects of Dexmedetomidine and Midazolam on hemodynamic responses after tracheal intubation in elderly patients under Cataract surgery with general anesthesia in comparison to control group
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly patients over 65 years old candidate for cataract surgery with general anesthesia
ASA2-3
No allergy to any of the study medications
Exclusion criteria:
Hemodynamic changes over 30% that needed intervention
Patient who refusing
Severe drug complications
History of using opioid and alcohol
Changing the method of anesthesia
Severe chronic disease
Age
From 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
210
Actual sample size reached:
195
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided to three groups A, B, C in based on a simple random sampling by Random Allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blinded study the doctor and patient were unaware of type of medications and medications were prepared and encoded by anesthetist
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences., Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.MUI.MED.REC.1397.369
Health conditions studied
1
Description of health condition studied
Cataract surgery
ICD-10 code
H28
ICD-10 code description
Cataract in diseases classified elsewhere
2
Description of health condition studied
Tracheal intubation
ICD-10 code
Y84.8
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
Systolic Blood pressure
Timepoint
Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time
Method of measurement
Blood pressure monitoring device
2
Description
Diastolic blood pressure
Timepoint
Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time
Method of measurement
Blood pressure monitoring device
3
Description
Mean arterial Blood pressure
Timepoint
Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time
Method of measurement
Blood pressure monitoring device
4
Description
Heart rate
Timepoint
Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time
Method of measurement
Monitoring device
5
Description
Arterial oxygen saturation percentage
Timepoint
Before the anesthesia, 1, 3, 5, 10 during anesthesia, entering the recovery and discharge time
Method of measurement
Pulse oximetry
Secondary outcomes
1
Description
Surgery complictions
Timepoint
After the surgery in recovery
Method of measurement
Physical examination and observation by physician
2
Description
Recovery time
Timepoint
After the surgery
Method of measurement
Minute
Intervention groups
1
Description
Intervention group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. Patients in this group received Dexmedetomidine at a dose of 1 mic/kg by slow infusion
Category
Treatment - Drugs
2
Description
Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. The second group received Midazolam at a dose of 0.1 mg/kg by slow infusion
Category
Treatment - Drugs
3
Description
Control group: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and vital signs were recorded by standard monitoring devices including pulse oximeter, capnography, and ECG. In this group Normal Saline was given both volume and form with two previous medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Feyz Hospital
Full name of responsible person
Khosrou Naghibi
Street address
Feyz hospital., Modares Steet
City
Isfahan
Province
Isfehan
Postal code
73461-81764
Phone
+98 31 3445 2035
Email
Naghibi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor of Research and Technology of University., Isfahan University of Medical Science , Hezar jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Amir Beidokhti
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moshtagh St
City
Isfahan
Province
Isfehan
Postal code
8158968886
Phone
+98 31 3260 3538
Email
Amir.beidokhti71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Khosrou Naghibi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital., Modares St
City
Isfahan
Province
Isfehan
Postal code
7346181764
Phone
+98 31 3668 5555
Email
Naghibi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Beidokhti
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Moshtagh St
City
Isfahan
Province
Isfehan
Postal code
8158968886
Phone
+98 31 3260 3538
Email
Amir.beidokhti71@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