Determination of the Effectiveness of Two Drug Combinations of Ketamine Midazolam and Ketamine Propofol on the sedation level in Patients undergoing Phacoemulsification cataract surgery
Design
Randomised clinical trial, double blinded with a parallel group design of 68 patients candidate for cataract surgery who are randomly divided into two groups based on arandom number table.
Settings and conduct
In this study, two compounds of ketamine-midazolam and ketamine-propofol are used in two groups of cataract patients undergoing phacoemulsification surgery in the Feyz Hospital of Isfahan and the level of sedation is measured in each group..
Patient and researcher are not aware of the type of drug used.Data is also recorded by a person who is not aware of the type of medication used.
Participants/Inclusion and exclusion criteria
Entry conditions include patients who are candidates for cataract surgery and patients who are satisfied with the study. Conditions for not entering are items such as history of allergy or allergic reaction to any of the medication used in the study ; high intraocular pressure or intracranial pressure; cardiovascular risk; advanced epilepsy or history of seizure.
Intervention groups
In the first intervention group 0.5 mg/kg Ketamine with 1 mg/kg propofol is injected. In case of need, 20 mg of ketamine is injected and recorded as a rescue dose and at the end the prescribed total dose is recorded.
In the second intervention group 0.05 mg/kg Midazolam with 0.5 mg/kg Ketamine is injected. In case of need, 25 mg of ketamine is injected and recorded as a rescue dose and at the end the prescribed total dose is recorded.
Comparison of the effect of ketamine-propofol and ketamine-midazolam on the sedation level during cataract surgery by phacoamulsification method
Public title
Propofol-Ketamine versus Midazolam-Ketamine for sedation in patients undergoing cataract surgery by phacoamulsification method.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for cataract surgery.
Patients who are satisfied to enter the study.
Patients aged 30-88 years.
Exclusion criteria:
History of allergy or allergic reaction to any of the medication used in the study.
History of head injuries.
High intraocular pressure or intracranial pressure.
Cardiovascular risk.
Severe respiratory disease.
Advanced epilepsy or history of seizure or neurological disorder.
The presence of any tumor or brain metastasis.
Use of any analgesic and anesthetic drug.
Age
From 30 years old to 88 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
In the operating room, patients are assigned to either midazolam ketamine or propofol ketamine based on a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the researcher are not aware of the type of medication used.Medications are prepared by an anesthetic expert who has no role in the study and then injected by an anesthetist to each patient group.
The person who records the data is also unaware of the type of medication used.
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 Sciences
Street address
Isfahan University of Medical Sciences and Health Services,Building No. 4, Research and Technology Deputy of University, Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.MUI.REC.1396.3.629
Health conditions studied
1
Description of health condition studied
Cataract surgery
ICD-10 code
H26.9
ICD-10 code description
Unspecified cataract
Primary outcomes
1
Description
Sedation level
Timepoint
After induction of anesthesia, during the procedure every 5 minutes.
Method of measurement
Modified Ramsay Sedation Scale(RSS)
Secondary outcomes
1
Description
Mean Arterial Pressure
Timepoint
Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours.
Method of measurement
pressure gauge
2
Description
Heart rate
Timepoint
Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours.
Method of measurement
Pulse oximeter
3
Description
Arterial oxygen saturation
Timepoint
Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours.
Method of measurement
Pulse oximeter
4
Description
Intensity of pain
Timepoint
During the process every 10 minutes and in recovery every 10 minutes up to two hours.
Method of measurement
Universal Pain assessment tool
5
Description
Frequency of complications
Timepoint
During the process every 10 minutes and in recovery every 10 minutes up to two hours.
Method of measurement
Adverse drug reaction questionnaire
6
Description
Recovery time
Timepoint
After completing the procedure until the exit from the recovery
Method of measurement
Minute Numbers
7
Description
Surgeon Satisfaction
Timepoint
During the procedure
Method of measurement
Likert scale
Intervention groups
1
Description
Intervention group: 0.5 mg/kg Ketamine with 1 mg/kg propofol in a syringe titre is injected. In case of need, 20 mg of ketamine is injected and recorded as a rescue dose and at the end of the prescribed total dose is recorded.
Category
Treatment - Drugs
2
Description
Intervention group: 0.05 mg/kg Midazolam with 0.5 mg/kg Ketamine in a syringe titre is injected. In case of need, 25 mg of ketamine is injected and recorded as a rescue dose and at the end of the prescribed total dose is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Faiz Hospital, Modarres St., Ghods Square
City
Isfahan
Province
Isfehan
Postal code
8149644874
Phone
+98 31 3445 2034
Email
hamidshetabi@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjooye Javanmard
Street address
Vice chancellor of research and technology of university, Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
Sh_haghjoo@med.mui.ac.ir
Web page address
http://research.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
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesia, Al-Zahra Medical Center, Sofe Avenue
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 313668555
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sofe Bolvar , Al-Zahra Medical Center, Department of Anesthesia
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesia, Al-Zahra Medical Center, Sofe Avenue
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamidshetabi@mui.ac.ir
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