Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgeryon

Comparison the effect of Melatonin and Dexmedetomidine on dose requirements of propofol in induction and maintenance of anesthesia by guidance of BIS in femur fracture surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20141009019470N103

Enrollment

Registered

2020-12-23

Start date

2021-02-18

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

Femur Fracture. Age-related osteoporosis with current pathological fracture, femur

Interventions

Intervention 1: Intervention group:In the dexmedetomidine group, after diluting the drug with normal saline in a 50 ml syringe, 1 µg / kg dexmedetomidine is injected within 15 minutes and after induct

Eligibility

Sex/Gender

All

Age

21 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 21 and 60 years ASA I ,II BMI 18-30 Elective tympanomastoidectomy

Exclusion criteria

Exclusion criteria: Hypersensitivity to propofol, dexmedetomidine or melatonin Consumption of opium and psychotropic drugs Consumption of beta blocker History of liver, kidney and cardiovascular failure Vascular stroke Neurological diseases Diabetes Hypothyroidism Peripheral or central vascular diseases History of high blood pressure History of taking anticonvulsant drugs Pace maker Duration of operation more than 180 minutes

Design outcomes

Primary

Measure	Time frame
Sedation. Timepoint: After transfer to the recovery room. Method of measurement: Richmond test.;Anxiety. Timepoint: The morning of the operation, before entering the operating room. In the recovery room and after full awakening in 30,60,90,120 minutes. Method of measurement: BECk Anxiety Assessment Test.;Pain. Timepoint: Severity of pain after waking up in the recovery room at 30,60,90,120 minute. Method of measurement: Visual analog Scale.;Nausea and Vomiting. Timepoint: After transferring patients to the recovery room. Method of measurement: PONV score: 0 = no emetic symptoms, 1 = nausea, 2 = vomiting.	—

Measure

Time frame

Sedation. Timepoint: After transfer to the recovery room. Method of measurement: Richmond test.;Anxiety. Timepoint: The morning of the operation, before entering the operating room. In the recovery room and after full awakening in 30,60,90,120 minutes. Method of measurement: BECk Anxiety Assessment Test.;Pain. Timepoint: Severity of pain after waking up in the recovery room at 30,60,90,120 minute. Method of measurement: Visual analog Scale.;Nausea and Vomiting. Timepoint: After transferring patients to the recovery room. Method of measurement: PONV score: 0 = no emetic symptoms, 1 = nausea, 2 = vomiting.

—

Secondary

Measure	Time frame
The duration of the end of surgery until the extubation. Timepoint: The interval from the end of surgery to the removal of the endotracheal tube. Method of measurement: Observation.;Duration of recovery. Timepoint: Duration of stay in recovery. Method of measurement: Observation.;The amount of bleeding. Timepoint: At the end of surgery. Method of measurement: Observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Jouybar

Shiraz University of Medical Sciences

joybarr@sums.ac.ir+98 71 3647 4270

Outcome results

None listed

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