The effect of Melatonin-fentanyl and Midazolam-fentanyl on pain and anxiety in cataract surgery

Comparing the effectiveness of preoperative injection of Melatonin-Fentanyl and Midazolam-Fentanyl on the amount of anxiety and pain in Cataract surgery under local anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160307026950N41

Enrollment

Registered

2022-07-13

Start date

2022-07-23

Completion date

Unknown

Last updated

2022-08-29

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 A: In this group of patients, after being placed on the surgical bed, they are subjected to cardiac and respiratory monitoring, and an intravenous line is establishe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 ASA class I, II and III Candidate for Cataract surgery under local anesthesia Ability to answer questions Informed consent for study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Pain intensity. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Behavioral Pain Scale questionnaire.;Anxiety amount. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Richmond Agitation-Sedation Scale questionnaire.	—

Measure

Time frame

Pain intensity. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Behavioral Pain Scale questionnaire.;Anxiety amount. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Richmond Agitation-Sedation Scale questionnaire.

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Secondary

Measure	Time frame
Heart Rate. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: ECG monitoring.;Blood Pressure. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Sphygmomanometer.;Respiratory Rate. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Counts per minute.;Recovery stay length. Timepoint: From the time of entry to recovery until exit. Method of measurement: Modified Aldrete Score questionnaire.	—

Measure

Time frame

Heart Rate. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: ECG monitoring.;Blood Pressure. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Sphygmomanometer.;Respiratory Rate. Timepoint: Before the intervention, after the intervention, every 10 minutes after the start of the operation until the end of recovery. Method of measurement: Counts per minute.;Recovery stay length. Timepoint: From the time of entry to recovery until exit. Method of measurement: Modified Aldrete Score questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmmar Hammadeh

Esfahan University of Medical Sciences

rayyanhmedi1@gmail.com+98 31 3662 0048

Outcome results

None listed

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