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IRCT201102223051N3 IRCT 2011-04-13 vice-chancellor for research of Qazvin university of medical sciences The effects of melatonin on anxiety and pain scores of patients, intraocular pressure and operating conditions during cataract surgery under topical anesthesia The effects of melatonin on anxiety and pain scores of patients, intraocular pressure and operating conditions during cataract surgery under topical anesthesia 2009-09-17 anticipated 60 Complete https://irct.ir/trial/3065 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. 2-3 anxiety. Intervention 1: sublingual melatonin 3 mg 60 minutes before surgery. Intervention 2: sublingual placebo tablet 60 minutes before surgery.
public Dr. Marzieh Beigom Khezri
Shahid Bahonar Blvd
Qazvin Iran (Islamic Republic of) +98 28 1222 2452 mkhezri@qums.ac.ir Qazvin university of medical sciences and health services scientific Dr. Marzieh beigom Khezri
Shahid Bahonar Blvd
Qazvin Iran (Islamic Republic of) +98 28 1222 2452 MKHEZRI@QUMS.AC.IR Qazvin university of medical sciences and health services Iran (Islamic Republic of) Inclusion criteria: age 25–80 years, scheduled for elective cataract surgery with intraocular lens implantation using phacoemulsification under topical anesthesia with an ASA physical status classification I–III. Exclusion criteria: patients with sleep disorders, autoimmune disease, diabetes, depressive disorder or expected compliance problems (known psychiatric disease), epilepsy, leukemia, insufficient pupillary dilation, nystagmus, deafness, allergy to the study drugs, ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week of admission, daily analgesic treatment, ß blockers, Coumadin derivates and those who could not tolerate Shioetz tonometer during IOP measurement. 25 years 80 years Both Y47 Complications of medical and surgical care Prevention Prevention sublingual melatonin 3 mg 60 minutes before surgery sublingual placebo tablet 60 minutes before surgery Anxiety. Timepoint: before premedication (T1), sixty minutes after premedication, on arrival in the operating room (T2), during the operation period (T3) and postoperatively. Method of measurement: VAS (verbal anxiety score). Intraocular pressure. Timepoint: before premedication (T1), and postoperatively. Method of measurement: Shioetz tonometer. Pain. Timepoint: before premedication (T1), 60 minutes after premedication, on arrival to the OR (T2), five minutes after the start of surgery (T3), and postoperatively before discharging the patient from the recovery room (T4). Method of measurement: Verbal pain score. Arterial blood pressure. Timepoint: before premedication (T1), sixty minutes after premedication, on arrival in the operating room (T2), during the operation period (T3) and postoperatively before discharging the patient from the recovery room (T4). Method of measurement: noninvasive measurement of blood pressure. Heart rate. Timepoint: before premedication (T1), sixty minutes after premedication, on arrival in the operating room (T2), during the operation period (T3) and postoperatively before discharging the patient from the recovery room (T4). Method of measurement: electrocardiogram. vice-chancellor for research of Qazvin university of medical sciences Approved 2009-07-20 Qazvin University of Medical Sciences & Health Services Shahid Bahonar Blvd Qazvin Iran (Islamic Republic of)