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IRCT2012092210900N1 IRCT 2013-09-22 Deputy of Research Kerman University of Medical Sciences Comparison of two method of spinal anesthesia in opium addicts Evaluation of the effects of adding Fentanyl to Bupivacaine in spinal anesthesia in opium addicted patients 2012-08-01 anticipated 60 Complete https://irct.ir/trial/11307 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: After approving by Ethic Committee of Kerman University of Medical Sciences, informed consent will be obtained from the patients. The method of sampling is simple randomization which amongst studied members of community who are referred to operation rooms of Afzalipoor, Shafa and Bahonar hospitals of kerman, one sample will be selected from the listed groups in the chances box by the patient accidentally. The medication is prepared by study leader and the anesthesiologist and technician who are responsible for taking care of the patient are blind to the medication as well as the patient. The preparation of patients in both group are similar and all the patients must be NPO for 8 hours before operation. The patients are notified of consuming regular opium as their usual pattern. 2 Opium Addiction. Intervention 1: Patients in control group undergo spinal anesthesia with 12.5 mg Bupivacaine (20mg/4ml, manufactured by ICI Pharmaceuticals India Limited) plus 0.5 ml sterile instilled water. Intervention 2: In intervention group spinal anesthesia is performed using 12.5 mg bupivacaine (20mg/4ml, made by ICI Pharmaceuticals India Limited) and 25µg fentanyl (0.5mg/10ml, manufactured by Aburaihan Co.Iran).
public Azam Karimi
Afzalipoor Hospital
Kerman Iran (Islamic Republic of) +98 34 1322 2250 javakrd34@gmail.com Kerman University of Medical Sciences scientific Hoseyn Sattari
Afzalipoor Hospital
Kerman Iran (Islamic Republic of) +98 34 1322 2250 hosattatri@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: 1) patient's consent of spinal anesthesia. 2) The patient who are admitted for lower abdomen and lower extremity surgery. 3) patients who are in the age range of 65-15 year 4) Patients in the height range between 185 - 150 cm 5)opium addict is a person who have used opium orally or inhales it at least for one year 6) surgery length of 80 to 150 minutes 7) No history of other drug abuse and psychological disorders. 8) Weight between 50 to 85 kg. exclusion criteria: 1- consuming other kinds of drugs 2- history of pulmonary or cardiac diseases 3-history of disorders which have absolute or partial contraindication for spinal anesthesia 4- history of hypersensitivity to fentanyl or bupivacaine. 15 years 65 years Male F11 Mental and behavioural disorders due to use of opioids Treatment - Drugs Treatment - Drugs Patients in control group undergo spinal anesthesia with 12.5 mg Bupivacaine (20mg/4ml, manufactured by ICI Pharmaceuticals India Limited) plus 0.5 ml sterile instilled water In intervention group spinal anesthesia is performed using 12.5 mg bupivacaine (20mg/4ml, made by ICI Pharmaceuticals India Limited) and 25µg fentanyl (0.5mg/10ml, manufactured by Aburaihan Co.Iran). The onset of pain after surgery. Timepoint: after operation. Method of measurement: asking the patient. Blood pressure. Timepoint: every 5 minutes and every 15 minutes in PACU. Method of measurement: digital monitoring device. The length of sensory nerves block. Timepoint: at 40,50,60,70,80,90,100,110 and 120 minutes. Method of measurement: skin stimulation test. The length of motor nerves block. Timepoint: at 40,50,60,70,80,90,100,110 and 120 minutes. Method of measurement: asking the patient to move his legs. The time of onset the analgesia. Timepoint: after performing the procedure. Method of measurement: skin stimulation test. Nausea and vomiting. Timepoint: throughout the operation and in PACU. Method of measurement: asking the patient. Itching. Timepoint: throughout the operation and in PACU. Method of measurement: asking the patient. Shivering. Timepoint: throughout the operation and in PACU. Method of measurement: observation. Deputy of Research Kerman University of Medical Sciences Approved 2012-05-19 Ethics committee of Kerman University of Medical sciences Jomhoori boulevard Kerman Iran (Islamic Republic of)