Comparison of sedation and hemodynamic changes resulting from administration of dexmedetomidine, ketamine and Etomidate with propofol during cataract surgery by Phacoemulsification method
Comparison of sedation and hemodynamic changes resulting from administration of dexmedetomidine, ketamine and Etomidate with propofol during cataract surgery by Phacoemulsification method
Design
The study of the two-course clinical trial of 128 patients was randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Candidates cataract surgery in Amirkabir Hospital in Arak are divided into 4 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidate for cataract surgery by Fico method, age 35 to 85 years, absence of mental disorders, lack of history of chronic use of sedatives, no alcohol and drugs, absence of severe obstructive pulmonary disease and asthma, no history of heart disease, heart block and bradycardia, absence of systolic blood pressure less than 90 mm Hg, absence of severe liver and renal failure, absence of uncontrolled diabetes, absence of cerebrovascular diseases
Exclusion criteria: patient dissatisfaction, existence of any complication during sedation that leads to a change in the method of anesthesia used or cancellation of surgery
Intervention groups
Intervention group: Dexmedetomidine is administered intravenously at a dose of 0.5 μg / kg. (Madonex ampoule 100 micro grams per millilitre made by Exir Pharmaceutical Company - Iran)
Intervention group: 0.1 mg / kg of Etomidate is given to patients. (Made by Abureihan Pharmaceutical Company - Iran)
Intervention group: 0.5 mg / kg ketamine is administered intravenously. (Made by Rotex Medica - Germany) (Rotexmedica GmbH Arzneimittelwerk)
Placebo group: Receive routine treatment with placebo.
Main outcome variables
Relaxation, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N156
Registration date:2021-04-25, 1400/02/05
Registration timing:prospective
Last update:2021-04-25, 1400/02/05
Update count:0
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedation and hemodynamic changes resulting from administration of dexmedetomidine, ketamine and Etomidate with propofol during cataract surgery by Phacoemulsification method
Public title
Comparison of sedation and hemodynamic changes resulting from administration of dexmedetomidine, ketamine and Etomidate with propofol during cataract surgery by Phacoemulsification method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for cataract surgery by Fico method
Age 35 to 85 years
Absence of mental disorders
Lack of history of chronic use of sedatives
No alcohol and drugs
Absence of severe obstructive pulmonary disease and asthma
No history of heart disease, heart block and bradycardia
Absence of systolic blood pressure less than 90 mm Hg
Absence of severe liver and renal failure
Absence of uncontrolled diabetes
Absence of cerebrovascular diseases
Exclusion criteria:
Patient dissatisfaction
Age
From 35 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in4 groups A and B and C and D. In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.ARAKMU.REC.1399.339
Health conditions studied
1
Description of health condition studied
Cataract surgery
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Sedation
Timepoint
Every 5 minutes during surgery and in recovery and 1, 2 and 4 hours after surgery
Method of measurement
Ramsay score
2
Description
Pain
Timepoint
During surgery every 5 minutes and during recovery and 1, 2 and 4 hours after surgery
Method of measurement
Visual analog pain score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dexmedetomidine is administered intravenously at a dose of 0.5 μg / kg. (Madonex ampoule 100 micro grams per millilitre made by Exir Pharmaceutical Company - Iran)
Category
Treatment - Drugs
2
Description
Intervention group: 0.1 mg / kg of Etomidate is given to patients. (Made by Abureihan Pharmaceutical Company - Iran)
Category
Treatment - Drugs
3
Description
Intervention group: 0.5 mg / kg ketamine is administered intravenously. (Made by Rotex Medica - Germany) (Rotexmedica GmbH Arzneimittelwerk)
Category
Treatment - Drugs
4
Description
Control group: Receive routine treatment with placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?