The Effect of Melatonin on Pneumatic Tourniquet Ischemia Reperfusion Injury in Lower Extremity Orthopedic Operatio

Phase 2

Recruiting

Conditions: Orthopedic surgery of the lower extrimites.
S82.201A
Unspecified fracture of shaft of right tibia, initial encounter for closed fracture

Registration Number: IRCT20141009019470N87

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

ASA Class I, II
Age range 18-65 years
Patients undergoing lower limb orthopedic surgery using tourniquet
Morning schedule

Exclusion Criteria

BMI> 30 kg/m2
Liver disorders
Patients with severe renal failure
Patients with metabolic acidosis
Patients with congestive heart failure
Blood transfusion
smoking
alcohol consumption
Pregnancy or breastfeeding
Patients taking any anti-oxidant
Drug Allergies
Contraindication of Spinal Anesthesia
Mental disorders which are require drug therapy and analgesics

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of superoxide dismutase. Timepoint: The night before surgery, pre-medication or placebo are taken immediately before spinal anesthesia and 30 minutes after tourniquet inflatation, then 15 minutes after tourniquet removal for measuring superoxide dismutase. Method of measurement: Enzyme kits.;Serum levels of malondialdehyde. Timepoint: The night before surgery, pre-medication or placebo are taken immediately before spinal anesthesia and 30 minutes after tourniquet inflatation, then 15 minutes after tourniquet removal for measuring superoxide dismutase. Method of measurement: Enzyme kits.

Secondary Outcome Measures

Name	Time	Method
Sedation Score. Timepoint: It is measured before melatonin administration and at intervals of 5,10,20,30,45,60,80 minutes after melatonin administration. Method of measurement: Ramsey Score.;Patient satisfaction. Timepoint: At the end of the operation. Method of measurement: Likert criteria.