Comparison of melatonin and midazolam on preoperative anxiety and intraoperative hemodynamic disorders in cataract surgery patients

Comparison of melatonin and midazolam on preoperative anxiety and intraoperative hemodynamic disorders in patients candidates for cataract surgery

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190618043934N15

Enrollment

Registered

2022-11-01

Start date

2022-11-06

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract. Age-related cataract

Interventions

Intervention 1: Intervention group: Intervention group 1 patients will receive melatonin (0.1 mg/kg melatonin tablets manufactured by ASI Italy) one hour before the operation. Intervention 2: Interven

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Having informed consent to enter the study ASA class 1 and 2

Exclusion criteria

Exclusion criteria: Having a drug addiction Failure to cooperate with the study manager Heart failure Uncontrolled blood pressure Anticoagulant use Taking anti-epileptic drugs Taking immunosuppressive drugs History of liver or kidney diseases Confucius Dementia Lack of verbal communication Chronic use of narcotics Treatment with barbiturates or antipsychotic drugs Allergy Body mass index below 18.5 or above 30

Design outcomes

Primary

Measure	Time frame
Anxiety. Timepoint: The patient's anxiety will be evaluated before the administration of the medicine in the eye department (2 hours before the operation), before the surgery and before entering the operating room and in the waiting room for the operation in a conscious state (half an hour before the operation) using Beck's anxiety questionnaire. Method of measurement: Beck Anxiety Questionnaire.;Hemodynamics of the patient. Timepoint: Hemodynamics of the patients before the operation (2 hours before the operation), during (half an hour after the start of the operation in the operating room) and after the surgery (after the patient is fully awake, 6 hours after the operation) are investigated by the researcher. Method of measurement: Hemodynamics of patients, including blood pressure before (2 hours before the operation) and after the operation (after the patient is fully awake, 6 hours after the operation) in the ward using a sphygmomanometer and a medical phone by the study manager (medical intern) and counting Heart rate will be obtained using the radial pulse. Also, the monitoring device in the operating room will be used to check the hemodynamics during the operation (half an hour after the start of the operation in the operating room).	—

Measure

Time frame

Anxiety. Timepoint: The patient's anxiety will be evaluated before the administration of the medicine in the eye department (2 hours before the operation), before the surgery and before entering the operating room and in the waiting room for the operation in a conscious state (half an hour before the operation) using Beck's anxiety questionnaire. Method of measurement: Beck Anxiety Questionnaire.;Hemodynamics of the patient. Timepoint: Hemodynamics of the patients before the operation (2 hours before the operation), during (half an hour after the start of the operation in the operating room) and after the surgery (after the patient is fully awake, 6 hours after the operation) are investigated by the researcher. Method of measurement: Hemodynamics of patients, including blood pressure before (2 hours before the operation) and after the operation (after the patient is fully awake, 6 hours after the operation) in the ward using a sphygmomanometer and a medical phone by the study manager (medical intern) and counting Heart rate will be obtained using the radial pulse. Also, the monitoring device in the operating room will be used to check the hemodynamics during the operation (half an hour after the start of the operation in the operating room).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZabihullah Mohaqiq

Birjand University of Medical Sciences

oabstudent@gmail.com+98 56 3232 3232

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026