A comparative study of two sedation methods during cataract surgery with two combinations of sodium thiopental and ketamine vs propofol and ketamine under local anesthesia in 60 patients who are candidates for cataract surgery due to old age and the effectiveness and side effects of this combination
Determining the effectiveness of the most studied drugs with the least side effects
Design
Patients are randomly divided into two groups A and B by random allocation software. In one group, the combination of sodium thiopental and ketamine is used, and in the other group, the combination of propofol and ketamine is used. There are 30 people in each group.
Settings and conduct
A three-blind clinical trial at Faiz Medical Education Center in 2022-2023
Participants/Inclusion and exclusion criteria
Conditions of non-entry: history of alcohol addiction, smoking, drugs, seizures and sensitivity to drugs used in research
Entry requirements: age 30 to 70 years old - cataract caused by aging - ASA 1,2,3
Intervention groups
The combination of sodium thiopental and ketamine compared with propofol and ketamine
Main outcome variables
Choosing one of the medicinal combinations of sodium thiopental and ketamine or propofol and ketamine for sedation during cataract surgery is to achieve higher quality in surgery and fewer complications after surgery, considering achieving the desired level of sedation and limiting the patient's activity during surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100926004819N6
Registration date:2023-01-27, 1401/11/07
Registration timing:registered_while_recruiting
Last update:2023-01-27, 1401/11/07
Update count:0
Registration date
2023-01-27, 1401/11/07
Registrant information
Name
Saied Morteza Heidari Tabaei Zavareh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1267 6415
Email address
m_heidari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-09, 1401/10/19
Expected recruitment end date
2023-02-08, 1401/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of two sedation methods during cataract surgery with two combinations of sodium thiopental and ketamine vs propofol and ketamine under local anesthesia in 60 patients who are candidates for cataract surgery due to old age and the effectiveness and side effects of this combination
Public title
Comparative investigation of two sedation methods during cataract surgery with two combinations of sodium thiopental and ketamine vs propofol and ketamine under local anesthesia.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for cataract surgery due to old age
Consent to participate in the study
Age between 30 and 70 years
ASA1/2/3
Exclusion criteria:
Need general anesthesia
Seizures and response to study drugs
High risk of surgery such as monocular or traumatic patients
History of alcoholism, smoking, drugs
Age
From 30 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization method. The randomization unit is individual and layered randomization is not used. The randomization tool is Randomize Allocation software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, one group of patients received ketamine and propofol, and the other group received ketamine and sodium thiopental. The study is triple-blind, which means the patient does not know about his group, the person who collects the data does not know which patient received which combination, and the statistical analyst does not know about the groups either.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of isfehan university of medical science
Street address
feiz hospital
City
isfehan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Approval date
2022-05-27, 1401/03/06
Ethics committee reference number
IR.MUI.MED.REC.1401.098
Health conditions studied
1
Description of health condition studied
senile cataract
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Appropriate sedation during surgery with monitoring of vital signs during surgery
Timepoint
0, 10, 20, 30, 40, 60 minutes in the operating room and 0, 15, 30 minutes in recovery
Method of measurement
monitoring device
2
Description
Pain intensity during and after surgery
Timepoint
During recovery and during surgery
Method of measurement
questionnaire
3
Description
Consent of the surgeon and the patient
Timepoint
During recovery and during surgery
Method of measurement
questionnaire
4
Description
drug's side effect
Timepoint
in recovery room , after being alert
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group, after placing the patient on the surgical bed, ambulatory monitoring of blood pressure, ECG, pulse oximetry and capnograph is established for monitoring the patient during the operation. Systolic and diastolic blood pressure, arterial blood oxygen saturation, end-expiratory CO2 and heart rate are measured and recorded. Then, to start sedation, the combination of fentanyl with a dose of 1µ/Kg, propofol with a dose of 2mg/kg/lit and ketamine with a dose of 0.3mg/kg will be used, then during surgery to maintain sedation with ketamine with a dose of 0.3mg/kg every five minutes and Thiopental sodium is found at a dose of 0.3 mg/kg every five minutes.
Category
Rehabilitation
2
Description
Intervention group: The second group, after placing the patient on the surgical bed, ambulatory monitoring of blood pressure, ECG, pulse oximetry and capnograph is established for monitoring the patient during the operation. Systolic and diastolic blood pressure, arterial blood oxygen saturation, end-expiratory CO2 and heart rate are measured and recorded. Then, to start sedation, fentanyl with a dose of 1µ/Kg, propofol with a dose of 2mg/kg/lit, and ketamine with a dose of 0.3mg/kg will be used, then during surgery to maintain sedation with a combination of ketamine with a dose of 0.3mg/kg every five minutes. and propofol at a dose of 2 mg/kg every five minutes.