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IRCT20230715058780N1 IRCT 2023-07-28 Esfahan University of Medical Sciences Comparative study of efficacy and side effects of combination Nesdonal - Fentanyl - Midazolam with Etomidate - Fentanyl - Midazolam for sedation of patients undergoing cataract surgery Comparative study of efficacy and side effects of combination Nesdonal - Fentanyl - Midazolam with Etomidate - Fentanyl - Midazolam for sedation of patients undergoing cataract surgery 2023-08-05 anticipated 52 Complete https://irct.ir/trial/71612 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of each day, samples are selected based on the inclusion criteria and after informed consent, random allocation is done based on the file number by random allocation software. People are divided into two groups A and B, for the purpose of blinding, only one reliable person, other than the researcher and data collector, is aware of the type of intervention, then each group is printed in two separate but similar lists. The type of sedation and the people in each group are confirmed by respected anesthesia experts. The data collector only knows the patients by their file number and has no knowledge of the type of intervention. Also, these data are still available to the data analyst in two groups, nicknamed A and B, and the type of intervention remains with the designated person until the end of the analysis, Blinding description: The three-way blinding of the study in terms of: 1) the patient does not know the type of injectable drugs. 2) The data collector has no knowledge of injectable drugs. 3) The data analyst has no knowledge of which group the data belongs to. For the purpose of blinding, similar syringes are used without a specific color and name and are covered with aluminum foil, and after collecting the data until the end of the statistical analysis, Randomly, one group is called A and the other B. 3 Cataract surgery. Intervention 1: Intervention group: Intervention group: The FIRST group is first injected with midazolam and fentanyl intravenous bolus with the following dose: fentanyl 1 Microg/Kg, midazolam 0.02 Mg/Kg, then after 3 minutes intravenous bolus Nesdonal is injected with the following dose: 3mg/kg. Intervention 2: Intervention group :The second group is first injected with intravenous midazolam and fentanyl bolus with the following dose: midazolam 0.02 mg/Kg, fentanyl 1 Microg/Kg, then after 3 minutes, Etomidate is injected as an infusion: 0.03mg/kg/h. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not decided yet
public Dr. Mitra Jabal Ameli
School of Medicine., Isfahan University of Medical Sciences and Health Services., Hazar Jarib St
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 1992 jabalameli@med.mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Mitra Jabal Ameli
School of Medicine., Isfahan University of Medical Sciences and Health Services., Hazar Jarib St
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3620 1992 jabalameli@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Cataract surgery candidates for emulsification method Having (ASA) between 1 and 3 Age between 18 and 70 years Consent to participate in the study 18 years 70 years Both Parkinson's Occurrence of acute cardiac ischemia in the last three months Having a history of narcotic drugs use Having a history of allergy to anesthetics Pregnancy Weighing more than one hundred kilograms Baseline blood pressure greater than 180/110 Dyspenea Psychosis H25.0 Age-related incipient cataract Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: The FIRST group is first injected with midazolam and fentanyl intravenous bolus with the following dose: fentanyl 1 Microg/Kg, midazolam 0.02 Mg/Kg, then after 3 minutes intravenous bolus Nesdonal is injected with the following dose: 3mg/kg Intervention group :The second group is first injected with intravenous midazolam and fentanyl bolus with the following dose: midazolam 0.02 mg/Kg, fentanyl 1 Microg/Kg, then after 3 minutes, Etomidate is injected as an infusion: 0.03mg/kg/h Blood pressure. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device. Respiratory rate per minute. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device. Heart rate per minute. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device. Blood oxygen saturation percentage. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device. Determining and comparing the average length of stay in recovery Community Verified icon. Timepoint: After transfer to recovery until the end. Method of measurement: timer. Determining and comparing the frequency of sedation. Timepoint: At the time of receiving the drugs and 5, 10, 20 minutes after the start of the surgery Community Verified icon. Method of measurement: Determining sedation with the Ramsay-Sedation-Scale. Determining and comparing the frequency of surgeon satisfaction Community Verified icon. Timepoint: End of surgery. Method of measurement: CHECK LIST. Determining and comparing the frequency of intramuscular metoclopramide consumption in recovery. Timepoint: After exiting recovery. Method of measurement: Determining nausea based on Baxter Retching Faces and metoclopromide injection in scores higher than 6 and counting doses. Esfahan University of Medical Sciences Approved 2023-04-01 Ethics committee of Isfahan University of Medical Sciences Research and Technology Vice-Chancellorm., Building No. 4., Isfahan University of Medical Sciences and Health Care Services., Hazar Jarib St esfahan Isfehan Iran (Islamic Republic of)