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IRCT138903013991N1 IRCT 2009-03-21 Iran University of Medical Science Comparison of co-administration of clonidine and pethdine with bupivacaine during spinal anesthesia Comparison of co-administration of clonidine and pethdine with bupivacaine during spinal anesthesia 2009-03-21 anticipated 50 Complete https://irct.ir/trial/4162 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Spinal anesthesia. Intervention 1: Spinal anesthesia with 15 mg Bupivacaine 0.5%. Intervention 2: Spinal anesthesia with 0.75 mg/kg pethidine + 0.75 microgram/kg clonidine.
public Reza Salmanian
Niayesh st., Satarkhan ave.
Tehran Iran (Islamic Republic of) +98 21 6435 2326 salmanian@gmail.com Iran university of medical sciences scientific Farnad Imani
Niayesh st., Sattarkhan Ave.
Tehran Iran (Islamic Republic of) +98 21 6435 2344 farimani@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients in class I or II ASA are selected for surgery in lower limbs at Rasoule akram Hospital. Exclusion criteria: Any known contraindication for spinal anesthesia, such as increased intracranial pressure, neurological disorders, hemorrhagic diathesis, or infection at the puncture site, disorientation, bilateral lower limb Fx., pelvic Fx., diabetes mellitus, miteral stenosis, aortic stenosis, allergy to bupivacaine or clonidine or pethidine. 15 years 50 years Both Y48.4 Anaesthetic, unspecified Treatment - Drugs Treatment - Drugs Spinal anesthesia with 15 mg Bupivacaine 0.5% Spinal anesthesia with 0.75 mg/kg pethidine + 0.75 microgram/kg clonidine Systolic Blood Pressure. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: With automatic BP indicator. Level of sensory block. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: Evaluation for level of sensory block at different dermatome with blunt needle fo e. Motor Block. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: 1=unable to move hip, 2=unable to move knee and 3=unable to move foot. Sedation rate. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: 0=anxiet, 1=awake and calm, 2=Sleepy, 3=Sleepy and responsive to sound, 4=Sleepy and responsive to painfull stimuli, 5=Unresponsive. Heart rate. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: ECG monitoirg. Analgesic request. Timepoint: Every 1 hour for 24 hours. Method of measurement: Patient's request. Vomitting. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: Observation. Bradicardia. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: ECG monitoirg. Nausea. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: Observation. Hypotension. Timepoint: First 10 minutes: every 2 minutes, next 10 minutes: every 3 minutes and next 160 minutes: every 5 minutes. Method of measurement: Observation on Monitoring of Blood pressur indicator. Iran University of Medical Science Approved 2009-02-21 Iran University of Medical Sciences Hemmat Expway, Iran University of Medical Sciences Tehran Iran (Islamic Republic of)