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IRCT20160307026950N45 IRCT 2022-09-10 Esfahan University of Medical Sciences Investigating the sedative effect of Melatonin in Cataract surgery Investigating the effect of oral Melatonin premedication on the quality of sedation and pain scale in Cataract surgery 2022-09-23 anticipated 40 Complete https://irct.ir/trial/65639 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number, Blinding description: This is a triple-blind clinical trial; In this way, before obtaining consent, patients are informed about the study but do not know which group they will be in and therefore are blind. Also, the researcher who records the patient's symptoms is different from the nurse who injects the drug and does not know the type of drug and is blind. Analysts who analyze the data collected during the study also do not know the type of intervention applied in each group and are blind. 3 Cataract. Intervention 1: Intervention group: In this group, patients receive a sublingual tablet containing 3 mg of Melatonin manufactured by Norm Life 1 hour before surgery. After being placed on the surgical bed, he is subjected to cardiac and respiratory monitoring, an intravenous line is established for drug injection, as well as the measurement criteria are explained to the patient. Then the patient is put under anesthesia and the operation begins. The patient's symptoms are measured and recorded until the end of the operation and then during recovery. Intervention 2: Control group: In this group, patients receive a placebo sublingual tablet 1 hour before surgery. After being placed on the surgical bed, he is subjected to cardiac and respiratory monitoring, and an intravenous line is established for drug injection, as well as the measurement criteria are explained to the patient. Then the patient is put under anesthesia and the operation begins. The patient's symptoms are measured and recorded until the end of the operation and then during recovery. 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 There is no more information
public Shahrzad Andalib
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Andalibshahrzad@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age over 18 ASA class I, II and III Candidate for Cataract surgery Informed consent for study 18 years no limit Both Patients with a history of obstructive sleep apnea Patients treated with psychiatric drugs Patients with autoimmune diseases, diabetes, nystagmus, leukemia and deafness Allergy to the drugs used Use of painkillers in the past week BMI index greater than 35 H25 Age-related cataract Prevention Placebo Intervention group: In this group, patients receive a sublingual tablet containing 3 mg of Melatonin manufactured by Norm Life 1 hour before surgery. After being placed on the surgical bed, he is subjected to cardiac and respiratory monitoring, an intravenous line is established for drug injection, as well as the measurement criteria are explained to the patient. Then the patient is put under anesthesia and the operation begins. The patient's symptoms are measured and recorded until the end of the operation and then during recovery. Control group: In this group, patients receive a placebo sublingual tablet 1 hour before surgery. After being placed on the surgical bed, he is subjected to cardiac and respiratory monitoring, and an intravenous line is established for drug injection, as well as the measurement criteria are explained to the patient. Then the patient is put under anesthesia and the operation begins. The patient's symptoms are measured and recorded until the end of the operation and then during recovery. Intensity of pain. Timepoint: before the intervention, before the operation, after anesthesia and then every 10 minutes until the end of recovery. Method of measurement: Behavioral Pain Scale questionnaire. Heart Rate. Timepoint: before the intervention, before the operation, after anesthesia and then every 10 minutes until the end of recovery. Method of measurement: ECG monitoring. Blood Pressure. Timepoint: before the intervention, before the operation, after anesthesia and then every 10 minutes until the end of recovery. Method of measurement: Sphygmomanometer. Esfahan University of Medical Sciences Approved 2020-11-30 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)