anxiety. Complications of medical and surgical care
Conditions
Interventions
Intervention 1: sublingual melatonin 3 mg 60 minutes before surgery. Intervention 2: sublingual placebo tablet 60 minutes before surgery.
Prevention
sublingual melatonin 3 mg 60 minutes before surgery
sublingual placebo tablet 60 minutes before surgery
Sponsors
vice-chancellor for research of Qazvin university of medical sciences
Eligibility
Sex/Gender
All
Age
25 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Marzieh Beigom Khezri
Qazvin university of medical sciences and health services
Outcome results
None listed