Comparison of Dexmedetomidine and Propofol with Ketamine-Propofol combination for Sedation in Cataract Surgery
Design
The study of the two-course clinical trial of 96 patients was randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Candidates for cataract surgery in Amirkabir Hospital in Arak are divided into 3 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:Age 18 to 85 years, both sexes ,candidate for cataract surgery ,absence of mental disorders ,lack of chronic history of sedatives ,no alcohol and drugs ,lack of allergy to the drugs used ,absence of severe obstructive pulmonary disease and name ,no history of heart disease, heart block and bradycardia ,absence of systolic blood pressure less than 90 mm Hg ,absence of severe liver failure ,absence of uncontrolled diabetes ,absence of cerebrovascular diseases
Exclusion criteria:Patient dissatisfaction ,existence of any complication during sedation that leads to change of anesthesia schedule or cancellation of surgery.
Intervention groups
Intervention group 1: Dexmedetomidine dose of 0.5 microgram in kilogram will injected intravenously to patients in 10 minutes.
Intervention group: 20 milliliter of propofol and 2 milliliter of ketamine and 28 milliliter of normal saline are mixed. The resulting solution contains 4 milligram of propofol and 2 milligramof ketamine. 125. 0 milliliter in kilogram in ten minutes
Intervention group 3: They receive 0.3 milligram in kilogram of propofol by intravenous bolus injection and then 0.5 milligram in kilogram per hour by slow intravenous infusion.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N148
Registration date:2020-09-21, 1399/06/31
Registration timing:registered_while_recruiting
Last update:2020-09-21, 1399/06/31
Update count:0
Registration date
2020-09-21, 1399/06/31
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
2020-06-30, 1399/04/10
Expected recruitment end date
2021-07-01, 1400/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine Versus Ketamine-Propofol combination versus Propofol for Sedation in Cataract Surgery
Public title
Comparison of Dexmedetomidine Versus Ketamine-Propofol combination versus Propofol for Sedation in Cataract Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 85 years
Both sexes
Candidate for cataract surgery
Absence of mental disorders
Lack of chronic history of sedatives
No alcohol and drugs
Lack of allergy to the drugs used
Absence of severe obstructive pulmonary disease and name
No history of heart disease, heart block and bradycardia
Absence of systolic blood pressure less than 90 mm Hg
Absence of severe liver failure
Absence of uncontrolled diabetes
Absence of cerebrovascular diseases
Exclusion criteria:
Patient dissatisfaction
Existence of any complication during sedation that leads to change of anesthesia schedule or cancellation of surgery.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B and C.
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
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Not 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
2020-06-28, 1399/04/08
Ethics committee reference number
IR.ARAKMU.REC.1399.130
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Pain
Timepoint
Every 5 minutes in surgery and recovery
Method of measurement
Visual analog scale pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Dexmedetomidine dose of 0.5 microgram in kilogram will injected intravenously to patients in 10 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: 20 milliliter of propofol and 2 milliliter of ketamine and 28 milliliter of normal saline are mixed. The resulting solution contains 4 milligram of propofol and 2 milligramof ketamine. 0.125 milliliter in kilogram in ten minutes
Category
Treatment - Drugs
3
Description
Intervention group 3: They receive 0.3 milligram in kilogram of propofol by intravenous bolus injection and then 0.5 milligram in kilogram per hour by slow intravenous infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr HAlireza Kamali
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
alikamaliir@yahoo.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?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street