Orthopedic surgery of the lower extrimites. Unspecified fracture of shaft of right tibia, initial encounter for closed fracture
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: Patients in melatonin group receive 10 mg oral melatonin tablets the night before surgery and 2 hours before surgery. Intervention 2: Control gr
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ASA Class I, II Age range 18-65 years Patients undergoing lower limb orthopedic surgery using tourniquet Morning schedule
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSima Razmjooie
Shiraz University of Medical Sciences
Outcome results
None listed