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IRCT20220302054164N2 IRCT 2023-01-19 Arak University of Medical Sciences The effect of intravenous infusion of remifentanil and dexmedetomidine on hemodynamic changes and pain in patients undergoing cataract surgery The effect of intravenous infusion of remifentanil and dexmedetomidine on hemodynamic changes and pain in patients undergoing cataract surgery 2023-02-20 anticipated 122 Complete https://irct.ir/trial/66738 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, the patients who meet the criteria of the study will be selected by available sampling, then they will be assigned to two intervention groups, dexmedetomidine (D) and remifentanil (R), using random permuted blocks. In order to randomize patients, 17 blocks of 6 will be used: RDDRDR, RDRDRD, DRRDDR, etc. D indicates dexmedetomidine group and R indicates remifentanil group. The order of the blocks will be randomly determined using a table of random numbers, and then the patients will be assigned to remifentanil and dexmedetomidine groups based on the blocks. One of the researchers who will not play a role in data collection will do the sequence of random allocation of blocks. The intervention will be done by other researchers. Blinding will be done with the help of a trained person who does not know about the allocation of patients in groups, and the measurements will be done by this person, Blinding description: The medications will be prepared by the anesthesiologist in charge of the research in syringes of the same size and color (only he knows the type and dosage of the drugs) and given to the anesthetist who is unaware of the type and dosage of the drug in the syringe, and finally, the questionnaire will be filled in by the same anesthetist, so this study will be double-blind. 3 Cataract. Intervention 1: Intervention group: Dexmedetomidine recipient Receiving ./5 μg/kg/h of dexmedetomidine from Elixir company using an infusion pump from the onset of induction of anesthesia to the end of surgery. Intervention 2: Intervention group: Remifentanil recipient Receiving 2 μg/kg/h of remifentanil from Elixir company using an infusion pump from the onset of induction of anesthesia to the end of surgery. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying the participants When: Access starts after the publication of the article To whom: researchers and students Conditions: In order to use the results Where to obtain: The person in charge of the project with the mentioned specifications How to obtain: The request is sent by email to the correspond author with the address S_omidvar1991@yahoo.com and the information is provided to the requester. Comments:
public Safoora Omidvar
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3526 s_omidvar1991@yahoo.com Arak University of Medical Sciences scientific Alireza Kamali
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 86 3383 8330 s_omidvar1991@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients referred to Amirkabir Arak Hospital for cataract surgery signing informed consent by patients Patients age 25-75 years American Society of Anesthesiologists (ASA) physical status classification I & II Candidates of local anesthesia 25 years 75 years Both H25 Age-related cataract Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine recipient Receiving ./5 μg/kg/h of dexmedetomidine from Elixir company using an infusion pump from the onset of induction of anesthesia to the end of surgery Intervention group: Remifentanil recipient Receiving 2 μg/kg/h of remifentanil from Elixir company using an infusion pump from the onset of induction of anesthesia to the end of surgery Hemodynamic variables based on the questionnaire. Timepoint: During surgery and recovery. Method of measurement: monitoring devices. Emergence agitation. Timepoint: Recovery room. Method of measurement: Richmond Agitation and Sedation Scale (RASS). Pain score. Timepoint: recovery. Method of measurement: The Visual Analogue Scale (VAS). Surgeon satisfaction. Timepoint: During surgery. Method of measurement: Asking the surgeon. Arak University of Medical Sciences Approved 2021-12-19 Ethics committee of Arak University of Medical Science A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran Arak Markazi Iran (Islamic Republic of)