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IRCT20191104045328N33 IRCT 2025-04-04 Arak University of Medical Sciences Sedation and analgesia of dexmedetomidine, fentanyl, and intrathecal neostigmine in femoral surgery Comparison of the sedation and analgesia effect of intrathecal dexmedetomidine, fentanyl and neostigmine in femur fracture repair surgery 2025-04-09 anticipated 135 Complete https://irct.ir/trial/82472 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to three intervention groups in order of arrival and based on a randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. A block randomization method with blocks of 9 will be used to allocate samples. Thus, using the site www.sealedenvelope.com, blocks of 9 letters A, B, and C will be randomly generated based on the sample size. The order of the letters A, B, and C in each block from the first block to the last block is considered as the randomization sequence. The generation of these blocks and their random sequence is entirely done by this site and the researcher is not aware of their sequence, Blinding description: This study will be based on a double-blind design. In this way, the anesthesiologist performing spinal anesthesia is aware of the patient grouping, but the patients and the intern who is responsible for collecting the data are unaware of the groupings, and finally the relevant intern will record the clinical information and outcomes of each patient and deliver it to the statistician. Patients who are anesthetized and are not aware of the medication they receive. Therefore, in this study, it can be stated that the patients and the intern evaluating the data are unaware of the groupings. 3 Femur fracture repair surgery. Intervention 1: Dexmedetomidine group: Patients receive 5 micrograms of dexmedetomidine (in a volume of 1 ml) manufactured by Exir Company of Iran along with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) manufactured by Molteni Company of Italy intrathecally. Intervention 2: Fentanyl group: 50 micrograms of fentanyl (1 ml) (manufactured by Caspian Tamin Company - Rasht, Iran) along with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) manufactured by Molteni Company, Italy, were administered intrathecally. Intervention 3: Neostigmine group: 50 mg of neostigmine (in a volume of 1 ml) manufactured by Caspian Tamin Pharmaceutical Company, Rasht – Iran, along with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) manufactured by Molteni Company, Italy, were administered intrathecally. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 2025/06/20 to 2028/06/20 for 3 years. To whom: University researchers Conditions: Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study. Where to obtain: University researchers and university professors can request Dr. Ahmadreza Behrouzi to use the data after contacting the relevant professor via message or email. Dr. Hesamuddin Modiri: Phone: 09183615107 Email: modir.he@gmail.com, Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education How to obtain: Letter writing should be done with professors and universities. Comments:
public Dr. Hesamuddin Modir
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Arak University of Medical Sciences
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 Dr.amaniarak@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for femur fracture repair surgery and refer to Vali Asr Hospital in Arak Consent to participate in the study BMI less than 30 ASA Class One and Two 18 years 60 years Both Presence of kidney, liver, heart disease, and cardiac arrhythmias Allergy to the medications used Psychological problems and absence of peripheral and central neuropathy Local infection in the spinal area M80.05 Age-related osteoporosis with current pathological fracture, femur Treatment - Drugs Treatment - Drugs Treatment - Drugs Dexmedetomidine group: Patients receive 5 micrograms of dexmedetomidine (in a volume of 1 ml) manufactured by Exir Company of Iran along with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) manufactured by Molteni Company of Italy intrathecally. Fentanyl group: 50 micrograms of fentanyl (1 ml) (manufactured by Caspian Tamin Company - Rasht, Iran) along with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) manufactured by Molteni Company, Italy, were administered intrathecally. Neostigmine group: 50 mg of neostigmine (in a volume of 1 ml) manufactured by Caspian Tamin Pharmaceutical Company, Rasht – Iran, along with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) manufactured by Molteni Company, Italy, were administered intrathecally. Pain score. Timepoint: Postoperatively, during recovery and 2, 4, 6, 12, and 24 hours after surgery. Method of measurement: visual analog scale. Onset of sensory and motor block. Timepoint: After spinal anesthesia. Method of measurement: Minute. Duration of sensory and motor block. Timepoint: It is measured from the start of spinal anesthesia to its end. Method of measurement: Minute. Arak University of Medical Sciences Approved 2024-09-08 Ethics Committee of Arak University of Medical Sciences Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)