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IRCT20220706055402N2 IRCT 2023-02-11 Ahvaz University of Medical Sciences dexmedetomidine with intravenous lidocaine in colonoscopy Comparison of the effect of dexmedetomidine with intravenous lidocaine in patients undergoing colonoscopy under sedation with propofol-fentanyl 2023-01-21 anticipated 120 Complete https://irct.ir/trial/68060 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: With the easy sampling method, the referring people who are eligible to enter the study are randomly divided into two intervention and control groups. In this study, the division of people is done by the four permutation block method. In this method, A represents an individual. is the one who receives the intervention and B represents the person who is placed in the control group. Considering the block of four, replace AABB with code 0, replace ABAB with code 1, replace ABBA with code 2, replace BAAB with code 3, replace with BBAA code 4 and BABA we give the code 5 to 9. Then, using the table of random numbers, we randomly choose a starting point and after that we consider 21 numbers in a row or column. Considering the order of the numbers in the table, for each We will replace the corresponding number with the number we found. Finally, by selecting 21 numbers from the table of allocation, the total of 120 people will be divided into two groups, Blinding description: After selecting the samples, the participants in the study, the endoscopic physician and the principal investigator are not aware of the allocation method and the drugs are injected by an anesthesiologist who is aware of the allocation and the data collection is done by them. 3 colonoscopy,sedation. Intervention 1: Intervention group: Intravenous lidocaine is injected with an initial dose of 1.5 mg/kg and a maintenance dose of 1 mg/kg/h, in addition to propofol 0.5 mg/kg and 1 microgram/kg of fentanyl. Intervention 2: Intervention group: Dexmedetomidine is injected with an initial dose of 1 μg/kg and a maintenance dose of 0.5 μg/kg per hour, plus propofol 0.5 mg/kg and fentanyl 1 μg/kg. 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 After the study will be determined
public Fatemeh Moftakhar
Imam Khomeini Hospital, Azadegan St
Ahwaz Iran (Islamic Republic of) 6193673111 +98 61 3338 3372 moftakhar-f@ajums.ac.ir Ahvaz University of Medical Sciences scientific Fatemeh Moftakhar
Imam Khomeini Hospital, Azadegan St
Ahwaz Iran (Islamic Republic of) 6193673111 +98 61 3338 3372 moftakhar-f@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Colonoscopy candidate patients who need anesthesia In the age range of 18 to 65 years Not suffering from cardiovascular diseases, kidney or liver failure No drug addiction Patient willingness to participate in the study 18 years 65 years Both The patient's unwillingness to participate in the study Intestinal perforation during the procedure Esophageal or stomach or intestinal bleeding during the procedure Changing the type of procedure during colonoscopy or the need for surgery during the procedure T88.52 Failed moderate sedation during procedure Treatment - Drugs Treatment - Drugs Intervention group: Intravenous lidocaine is injected with an initial dose of 1.5 mg/kg and a maintenance dose of 1 mg/kg/h, in addition to propofol 0.5 mg/kg and 1 microgram/kg of fentanyl. Intervention group: Dexmedetomidine is injected with an initial dose of 1 μg/kg and a maintenance dose of 0.5 μg/kg per hour, plus propofol 0.5 mg/kg and fentanyl 1 μg/kg. Level of sedation. Timepoint: From start to end of colonoscopy. Method of measurement: Ramsay Sedation Scale. Amount of pain. Timepoint: From start to one hour after colonoscopy. Method of measurement: Visual Analogue Scale. Ahvaz University of Medical Sciences Approved 2022-12-13 Ethics Committee of Golestan Educational-Research and Treatment Center of Ahvaz Jundishapur Universi Golestan hospital,Golestan Ave,Golestan town Ahvaz Khouzestan Iran (Islamic Republic of)