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IRCT20190325043107N33 IRCT 2023-07-19 Tabriz University of Medical Sciences Effects of propofol infusion with and without lidocaine on pain and need for sedation during ERCP Effects of propofol infusion with and without lidocaine on pain and need for sedation during Endoscopic Retrograde Cholangio Pancreatography(ERCP) 2023-05-07 anticipated 80 Complete https://irct.ir/trial/71406 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they were divided into two intervention groups (group A) and control group (group B), Blinding description: The thesis results analyst who analyzed the expected outcome and also the participants remained unaware of the type of procedure performed and were blind during the study; Therefore, this study was conducted in a double-blind manner. 2-3 Pain. Intervention 1: Intervention group: For the patients of this group, 1.5 mg of lidocaine will be injected for each kilogram of weight, and then they will receive 4 mg of lidocaine per kilogram of weight in one hour as an infusion. Then propofol as an infusion. It will be given at a rate of 2 to 4 mg per kilogram of weight per hour. Then, during ERCP, the intensity of pain and the level of sedation will be checked. Intervention 2: Control group: For the patients of this group, 4 cc of normal saline will be infused at the beginning and then 2 to 4 cc per hour. Then propofol will be given as an infusion at a rate of 2 to 4 mg per kilogram of weight per hour. became. Then, during ERCP, the intensity of pain and the level of sedation will be checked. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) ASA class I to III patients ERCP candidate 18 years 65 years Both Patients with arterial oxygen saturation less than 90% Heart rate less than 50 Seizure patients G89.1 Acute pain, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: For the patients of this group, 1.5 mg of lidocaine will be injected for each kilogram of weight, and then they will receive 4 mg of lidocaine per kilogram of weight in one hour as an infusion. Then propofol as an infusion. It will be given at a rate of 2 to 4 mg per kilogram of weight per hour. Then, during ERCP, the intensity of pain and the level of sedation will be checked. Control group: For the patients of this group, 4 cc of normal saline will be infused at the beginning and then 2 to 4 cc per hour. Then propofol will be given as an infusion at a rate of 2 to 4 mg per kilogram of weight per hour. became. Then, during ERCP, the intensity of pain and the level of sedation will be checked. Pain. Timepoint: Once every 10 minutes and for thirty minutes. Method of measurement: Visual Analogue Scale. Sedation. Timepoint: For a moment and for thirty minutes. Method of measurement: Patient observation. Tabriz University of Medical Sciences Approved 2023-05-07 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)