Spinal anesthesia (SA) is the choice method of anesthesia for Prostate gland surgery through urinary tract (Trans Urethral Resection of the Prostate- TURP). In conventional method of SA, which we ordinarily use 2 CC lidocaine 5% (100 mg), there are many dangerous complications in elderly patients such as ischemic heart disease, cardio-vascular collapse, Acute Tubular Necrosis (ATN) or even Acute Renal Failure (ARF). These complications may be occurred especially among patients who have cardio-vascular diseases such as systemic hypertension. As a result, the patients' morbidity and mortality may be increased. Neuro-axial usage of local anesthetic drugs such as lidocaine may create hypotension via blocking sympatic fibers. To solve this problem, we could decrease lidocaine dosage together with drugs, simultaneously. We could solely use narcotic drugs, because hypotension do not occurs subsequent of neuro-axial usage of narcotic drugs.
In this Double-blind Randomized Clinical Trial (RCT) study, we will compare anesthetic effects of a combination of anesthetic-narcotic drugs with the ordinary method. Doing spinal anesthesia, we will use 1 CC lidocaine 5% (50 mg) together with 1 CC fentanil (50 mcg) in treatment group. We hope this drug combination not only create a relevant painless level for the patients, but also inhibit hemodynamic variability. Therefore, we could expect to reduce morbidity and mortality resulted from the hemodynamic variability.
This will be a double-blind RCT. It means both the patients and the evaluators will not know which patient receive which treatment will.
Study population will be the candidate patients of TURP surgery. The inclusion criteria will be hypertensive patients age 50 and older who admit in the 15-Khordad hospital with Benign Prostate Hyperplasia (BPH).
There will be some exclusion criteria consisting of patient's inability to immobility when interning spinal needle; increasing Intra Cranial Pressure (ICP); coagulation disorders; skin or soft tissue infection in the spinal site; instability in hemodynamic features.
Demographic characteristics of all samples will be initially registered. Then, normal/saline serum (5cc/kg) will be infused for each patient. They will be also monitored concerning blood pressure and heart rate. Electro Cardio Graph (ECG) and pulse-oximetery will be done for all the samples. To implement SA, we will randomly assign the patients in the treatment (1 CC lidocaine + 1 CC Fantanil) and control (2 CC lidocaine) groups. The injections will be done through L4-L5 or L5-S1 intra-vertebral areas. The patients' BP and HR will be measured and recorded after spinal anesthesia and every 5 minutes. Major hypotension (descending BP greater than 20% of basic BP) and bradycardia (HR lower than 45/min) will be treated with ephedrine and atropine, respectively. PRBC transfusion will be done in patients with excessive bleeding. These patients will be excluded from the study.
According to previous similar studies, we determined 148 samples (74 samples for each group) in this research.