Comparison of the effects of Melatonin and Dexmedetomidine on Propofol consumption in anesthesia for ear surgeries using BIS monitoring.

Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in tympanomastoid operation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120214009011N4

Enrollment

Registered

2025-05-12

Start date

2025-01-01

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Otitis media. Otitis media, unspecified

Interventions

Intervention 1: Intervention Group (M):The surgical technique for all patients is standardized and performed by a specific surgeon. Before administering any medications to the patients, the forehead i

Eligibility

Sex/Gender

All

Age

21 Years to 60 Years

Inclusion criteria

Inclusion criteria: Adult patients with ASA grade II or III (American Society of Anesthesiology classification). Adult patients between 21 and 60 years old. Adult patients who are candidates for elective Tympanomastoid operation.

Exclusion criteria

Exclusion criteria: Allergy to the drugs used in the study. Patients with a history of liver failure, kidney failure, cardiovascular diseases, stroke, neurological disorders, endocrine diseases (such as diabetes and hypothyroidism), and peripheral or central vascular diseases. Patients with a history of taking anticonvulsant medications. Surgery duration longer than 180 minutes. All patients who do not consent to participate in the study.

Design outcomes

Primary

Measure	Time frame
Pain after surgery. Timepoint: Recovery and at the time of arrival and every 15 minutes. Method of measurement: Visual pain scale questionnaire.;Blood pressure. Timepoint: Recovery and at the time of arrival and every 15 minutes. Method of measurement: Monitoring.;Electrocardiogram. Timepoint: Recovery and at the time of arrival and every 15 minutes. Method of measurement: ECG examination.;Anxiety. Timepoint: Before surgery and in the recovery room. Method of measurement: Beck's standardized test.;Incidence of patient drowsiness(seduction). Timepoint: In the recovery room and after fully waking up in minutes (30, 60, 90, 120). Method of measurement: The Richmond Test.;The amount of propofol used. Timepoint: At the end of surgery. Method of measurement: Medical record.	—

Measure

Time frame

Pain after surgery. Timepoint: Recovery and at the time of arrival and every 15 minutes. Method of measurement: Visual pain scale questionnaire.;Blood pressure. Timepoint: Recovery and at the time of arrival and every 15 minutes. Method of measurement: Monitoring.;Electrocardiogram. Timepoint: Recovery and at the time of arrival and every 15 minutes. Method of measurement: ECG examination.;Anxiety. Timepoint: Before surgery and in the recovery room. Method of measurement: Beck's standardized test.;Incidence of patient drowsiness(seduction). Timepoint: In the recovery room and after fully waking up in minutes (30, 60, 90, 120). Method of measurement: The Richmond Test.;The amount of propofol used. Timepoint: At the end of surgery. Method of measurement: Medical record.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Salari

Shiraz University of Medical Sciences

Salari.mehrdad@gmail.com+98 71 3647 4270

Outcome results

None listed

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