Comparison of Dexmedetomidine and Midazolam anesthesia effect in elderly patients to be on Cataract surgery.
Design
Clinical trial with parallel group, double blinded, randomized on 121 patients, that Randomization was centralized with Random allocation software
Settings and conduct
The use of two different medications with specific dose and comparing their effects on sedation level and hemodynamic complications in Cataract surgery in Isfahan Feyz Hospital. The patient and doctor were unaware of the kind of medication
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients over 65 years old candidate for Cataract Surgery with ASA2-3; NO allergy to any of 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
Intervention group 1: Elderly patients candidate for Cataract Surgery with Dexmedetomidine
Intervention group 2: Elderly patients candidate for Cataract Surgery with Midazolam
Main outcome variables
Anesthesia level; Hemodynamic complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200510047389N1
Registration date:2020-05-17, 1399/02/28
Registration timing:retrospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
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
2020-05-14, 1399/02/25
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
2018-09-11, 1397/06/20
Actual recruitment end date
2019-11-11, 1398/08/20
Trial completion date
2019-11-16, 1398/08/25
Scientific title
Comparison of Dexmedetomidine and Midazolam Anesthesia Effect in Elderly Patients during Cataract Surgery
Public title
Comparison of Dexmedetomidine and Midazolam Anesthesia Effect in Elderly Patients during Cataract Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 65 years old candidate for Cataract Surgery with ASA 2-3
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
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
130
Actual sample size reached:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided to two groups 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 medication and medication were prepared and encoded by anesthetist
Placebo
Not 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 Science
Street address
Hezarjarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.MUI.MED.REC.1397.042
Health conditions studied
1
Description of health condition studied
Cataract Surgery
ICD-10 code
H28
ICD-10 code description
Cataract in diseases classified elsewhere
Primary outcomes
1
Description
Sedation level
Timepoint
Every 5 minutes during surgery
Method of measurement
Modified Observers Assessment of Alertness/Sedation Scale
Secondary outcomes
1
Description
Systolic Blood pressure
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Monitoring device
2
Description
Diastolic blood pressure
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Monitoring device
3
Description
Mean arterial Blood pressure
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Monitoring device
4
Description
Heart rate
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Heart rate monitoring device
5
Description
Arterial oxygen saturation percentage
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Pulse oximetry
6
Description
Pain level
Timepoint
Entering the recovery; Every 15 minute in the recovery
Method of measurement
Visual Analog Scale
7
Description
Surgeon satisfaction
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Likert questionnaire
8
Description
Patient satisfaction
Timepoint
Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery
Method of measurement
Likert questionnaire
Intervention groups
1
Description
Intervention group: Patients in first group receiving Dexmedetomidine 1 Mic/kg by slow infusion
Category
Treatment - Drugs
2
Description
Intervention group: Patients in second group receiving Midazolam 0.02 mg/kg by slow infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Khosrou Naghibi
Street address
Modares Street
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
Isfahan University of Medical Science., Hezarjarib 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
Mahgolsadat Matinkhah
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
Mahgol_mtn72@yahoo.de
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
Alzahra hospital., Sofe St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
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