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IRCT20161014030294N5 IRCT 2021-01-13 Arak University of Medical Sciences Investigation of the effect of Ketamine in comparison with Dexmedetomidine dose in pain management and postoperative complications of orthopedics Investigation of the effect of Ketamine in comparison with Dexmedetomidine dose in pain management and postoperative complications of orthopedics 2021-01-20 anticipated 70 Complete https://irct.ir/trial/53509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling is done purposefully. In this study, due to the existence of two types of treatment, the block randomization method is used. Is a randomization unit of the individual. Depending on the sample size, blocks with a capacity of 4 units are considered. In order to better randomize, the web-based software is used to prepare a randomization list, which creates random permutations for each type of treatment in each block, and due to the change of permutations in each block, concealment is also observed. The researcher's ability to predict the next treatment decreases during the study.Site used for random permutation block method: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: Patients who have undergone orthopedic surgery of the lower extremities of the femur or pelvis are included in the study by easy sampling. Patients are randomly divided into two groups of 35 people. Group 1 receives a pain pump containing Ketamine labeled A and group 2 receives a pain pump containing Dexmedetomidine labeled B. The preparation of the pain pump is done by someone outside the study and the caregiver does not know the type of medicine inside the pain pump. 3 Femoral orthopedic surgery. Intervention 1: Intervention group: They receive ketamine at a dose of 1 mg / kg in the pain pump after the operation. Complications and pain scores are observed before the intervention and after 8 hours after the operation in the recovery and transferred ward. Intervention 2: Control group: They receive dexmedetomidine at a rate of 1 microgram per kilogram in the pain pump after the operation. Observation of complications and pain score before the intervention and after 8 hours after the operation is performed every hour in the recovery and transferred ward. Yes - There is a plan to make this available What will be shared: All potential data can be shared after people have not been identified When: Start the access period 2 months after printing the results To whom: Researchers working in academic and scientific institutions Conditions: Use documentation by citing the source Where to obtain: Mansoreh Karimi Kia Arak University of Medical Sciences Phone 09181600717 Email karimikia93@gmail.com How to obtain: After receiving the request by phone or email, the data will be sent within 2 weeks. Comments:
public Mansoreh Karimi Kia
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) ٣٨١٩٦٩٣٣٤٥ +98 86 3313 6055 karimikia93@gmail.com Arak University of Medical Sciences scientific Behnam Mahmoudieh
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 Behnammahmoudye@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years orthopedic surgery of the lower limb or pelvis with general anesthesia consent to research absence of underlying diseases such as cardiovascular physical condition 1 and 2 American Society of Anesthesiologists (ASA) 18 years 65 years Both Hypersensitivity to Ketamine or Dexmedetomidine cardiovascular and pulmonary disease death of patient dissatisfaction with participation in the study withdrawal from the study at any stage s72 femoral fracture Treatment - Drugs Treatment - Drugs Intervention group: They receive ketamine at a dose of 1 mg / kg in the pain pump after the operation. Complications and pain scores are observed before the intervention and after 8 hours after the operation in the recovery and transferred ward. Control group: They receive dexmedetomidine at a rate of 1 microgram per kilogram in the pain pump after the operation. Observation of complications and pain score before the intervention and after 8 hours after the operation is performed every hour in the recovery and transferred ward. The extent of postoperative pain. Timepoint: Pain score before the intervention and after up to 8 hours after the operation every hour. Method of measurement: VAS scale. Arak University of Medical Sciences Approved 2020-11-29 Ethics Committee of Arak University of Medical Sciences A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak Markazi Iran (Islamic Republic of)