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IRCT20100926004819N6 IRCT 2023-01-27 Esfahan University of Medical Sciences Comparative investigation of two sedation methods during cataract surgery with two combinations of sodium thiopental and ketamine vs propofol and ketamine under local anesthesia. 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 2023-01-09 anticipated 60 Complete https://irct.ir/trial/68177 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. 2 senile cataract. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: The access period starts 12 months after the publication of the results To whom: Researchers working in academic institutions Conditions: If used for other studies Where to obtain: If you request access to the documents, send a message to the email below. fatemeh .sadat075@gmail.com How to obtain: Approval of Research Committee and Ethics Committee of Isfahan University of Medical Sciences Comments:
public Saied Morteza Heidari Tabaei Zavareh
Isfahan Province, Isfahan, Qods Square, Ayat A... Modares St., No. 1
isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 921 114 5026 fatemeh.sadat075@gmail.com Esfahan University of Medical Sciences scientific Saied Morteza Heidari Tabaei Zavareh
Isfahan Province, Isfahan, Qods Square, Ayat A... Modares St., No. 1
isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۶۱ +98 921 114 5026 fatemeh.sadat075@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Candidate patients for cataract surgery due to old age Consent to participate in the study Age between 30 and 70 years ASA1/2/3 30 years 70 years Both Need general anesthesia Seizures and response to study drugs High risk of surgery such as monocular or traumatic patients History of alcoholism, smoking, drugs T88.5 Other complications of anesthesia Rehabilitation Rehabilitation 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. 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. 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. Pain intensity during and after surgery. Timepoint: During recovery and during surgery. Method of measurement: questionnaire. Consent of the surgeon and the patient. Timepoint: During recovery and during surgery. Method of measurement: questionnaire. Drug's side effect. Timepoint: in recovery room , after being alert. Method of measurement: questionnaire. isfahan university of medical sciences Approved 2022-05-27 ethics committee of isfehan university of medical science feiz hospital isfehan Isfehan Iran (Islamic Republic of)