]>
IRCT20141209020258N141 IRCT 2020-04-09 Arak University of Medical Sciences Management of opioid-induced pruritus after spinal anesthesia in femoral fracture surgery Comparison of the effect of Midazolam, Dexamethasone, Ondansetron and Propofol in the prevention of opioid-induced pruritus after spinal anesthesia in femoral fracture surgery 2020-02-20 anticipated 132 Complete https://irct.ir/trial/46831 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple individual randomization with randomization with envelopes in 4 groups A and B and C and D . In this method, we write a few cards or letters as intervention groups and the same ‎number of cards for the control group, then the cards are mixed. One card is taken out and its ‎allocation is registered and the card is returned to the other cards after leaving. Then the cards ‎are mixed again and then another card is picked up. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Outcome elevator and analyzer and participant are blind. Outcome elevator and analyzer and participant don't aware from grouping. Each group of drugs will be prescribed as a bolus and then intravenous infusion. Patients and outcome elevator will be unaware of the prescribed medication. Bolus and infusion injection syringes as well as drug infusion sets will be covered with foil. After calculating the amount, the required drugs are drawn in 50 ML syringes and prescribed at the desired dose. 3 Femoral fracture surgery. Intervention 1: Intervention group1: We inject 4 milligram Ondansetron bolus followed by 50 millileter of distilled water with rate of 25 millileter per hour. Intervention 2: Intervention group 2: We inject 2 milligram Propofol bolus initially and then 10 micro grams per kilogram per minute (intravenous infusion drug is poured into 50 milliliter syringes). Intervention 3: Intervention group 3: We inject 8 milligram Dexamethasone and then infuse 50 milliliter of distilled water with rate of 25 milliliter per hour. Intervention 4: Intervention group 4: We inject 0.03 milligram Midazolam bolus and then infuse 0.02 milligram per kilogram per hours. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Hesamodin Modir How to obtain: They have to write letters to the professors and the university. Comments:
public Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years ASA class 1 and 2 Femoral fractures surgery No history of any skin condition associated with generalized itching No complaints of pruritus before surgery No history of drug addiction No history of seasonal allergies No history of long-term corticosteroid use Absence of motion sickness Absence of diabetes Absence of neuromuscular diseases 18 years 65 years Both Failure in the anesthesia and use another method Dissatisfaction S72 Fracture of femur Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: We inject 4 milligram Ondansetron bolus followed by 50 millileter of distilled water with rate of 25 millileter per hour. Intervention group 2: We inject 2 milligram Propofol bolus initially and then 10 micro grams per kilogram per minute (intravenous infusion drug is poured into 50 milliliter syringes). Intervention group 3: We inject 8 milligram Dexamethasone and then infuse 50 milliliter of distilled water with rate of 25 milliliter per hour. Intervention group 4: We inject 0.03 milligram Midazolam bolus and then infuse 0.02 milligram per kilogram per hours. Itching. Timepoint: During recovery and up to 12 hours after surgery, every 2 hours. Method of measurement: Observation. Sedation. Timepoint: Every 15 minutes until the end of surgery and in recovery and then every 2 hours to 12 hours after surgery. Method of measurement: Ramsey score. Arak University of Medical Sciences Approved 2020-02-09 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)