]>
IRCT20191104045328N49 IRCT 2025-12-30 Arak University of Medical Sciences Comparison of delirium after knee replacement surgery in elderly patients with propofol and dexmedetomidine. Comparison of the Incidence of Postoperative Delirium in Elderly Patients Over 60 Undergoing Knee Arthroplasty with General Anesthesia Using Propofol or Dexmedetomidine. 2026-01-10 anticipated 146 Complete https://irct.ir/trial/88315 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to two intervention groups based on their order of entry and according to a randomization sequence that will be generated in advance. This sequence will be unpredictable, and the allocation will be entirely random. Block randomization with blocks of 4 will be used for sample allocation. Using software to generate random numbers in a block design, a randomization sequence will be created according to the required sample size for the two groups. Initially, all possible combinations of the letters A and B within the 4-item blocks will be arranged. Then, one block is randomly selected, and its arrangement will be used for allocating participants. Afterward, this block is placed in the main container, and another block is selected. All these steps will be performed using software called Sealed Envelope. With this method, concealment will also be maintained. The concept of concealment means that the allocation of participants to groups is unpredictable. In practice, the researcher will not be able to predict which group the next participant will be assigned to, Blinding description: This study will be conducted as a double-blind trial. None of the patients will be aware of the type of drug they are receiving. These drugs will be administered by the anesthesiologist, with each drug drawn into a separate syringe. The syringes and the extension tubes connecting the syringes to the angiocatheter will be covered with foil, so the contents will remain unknown. As a result, the intern responsible for recording outcomes will not know the patient group assignment and will assess the patients based on their file numbers, then provide the collected data to the attending physician. 3 Postoperative Delirium. Intervention 1: Dexmedetomidine group: Patients in this group will receive dexmedetomidine (0.1 µg/kg/h) as a continuous infusion from the time of anesthesia induction until admission to the recovery room. Intervention 2: Propofol group: Patients in this group will receive propofol (100 µg/kg/min) as a continuous infusion from the time of anesthesia induction until admission to the recovery room . 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: The access period will start on 2026/04/19, and continue until 2029/04/18 for a duration of three 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. Alireza Susanabadi
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 dr.susanabadi@arakmu.ac.ir Arak University of Medical Sciences scientific 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 Iran (Islamic Republic of) Patients who are candidates for knee arthroplasty under general anesthesia Having informed consent to participate in the study Surgical duration between 60 and 150 minutes 60 years no limit Both Presence of systemic diseases and history of specific conditions, including renal, hepatic, and cardiovascular diseases, hypertension, diabetes, hematological and vascular diseases, psychotic and mental disorders, Parkinson’s disease, motion sickness, a history of chemotherapy, and malignancies. History of substance use and drug allergies, including absence of opioid use, chronic use of analgesics, hypersensitivity to the medications under study, and seasonal allergies. F05 Delirium due to known physiological condition Treatment - Drugs Treatment - Drugs Dexmedetomidine group: Patients in this group will receive dexmedetomidine (0.1 µg/kg/h) as a continuous infusion from the time of anesthesia induction until admission to the recovery room. Propofol group: Patients in this group will receive propofol (100 µg/kg/min) as a continuous infusion from the time of anesthesia induction until admission to the recovery room . Occurrence of delirium. Timepoint: After surgery. Method of measurement: Confusion Assessment Method. Duration of delirium. Timepoint: After surgery. Method of measurement: By the Watch. Time of onset of delirium. Timepoint: The first, second, and third days after surgery. Method of measurement: Patient file. Duration until discharge from the recovery unit. Timepoint: After surgical recovery. Method of measurement: Modified Aldrete Score. Mean arterial pressure. Timepoint: At the beginning of surgery and every 15 minutes during the operation, throughout the recovery period, and at 2, 4, and 6 hours after surgery. Method of measurement: NIBP monitoring device. Heart rate. Timepoint: At the beginning of surgery and every 15 minutes during the operation, throughout the recovery period, and at 2, 4, and 6 hours after surgery. Method of measurement: Cardiac monitoring device. Arterial blood oxygen saturation. Timepoint: At the beginning of surgery and every 15 minutes during the operation, throughout the recovery period, and at 2, 4, and 6 hours after surgery. Method of measurement: Pulse oximetry. Arak University of Medical Sciences Approved 2025-10-19 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)