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 surgeryo

Phase 2

Conditions: Femur Fracture.
Age-related osteoporosis with current pathological fracture, femur
M80.05

Registration Number: IRCT20141009019470N103

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 80

Inclusion Criteria

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.