The effects of melatonin on anxiety and pain scores of patients, intraocular pressure and operating conditions during cataract surgery under topical anesthesia
Phase 2
- Conditions
- anxiety.Complications of medical and surgical care
- Registration Number
- IRCT201102223051N3
- Lead Sponsor
- vice-chancellor for research of Qazvin university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.