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IRCT20220221054090N1 IRCT 2022-06-03 Ahvaz University of Medical Sciences Effect of intravenous Lidocaine in Endoscopy Evaluation of the sedative effect of intravenous lidocaine in patients undergoing Endoscopy with Propofol-Ketamine 2022-06-22 anticipated 138 Complete https://irct.ir/trial/62147 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By easy sampling method, the patients who are eligible to enter the study are randomly divided into two groups of intervention and control. In this study, the individuals are divided into four quadratic block methods.A Is the person receiving the intervention, and B represents the person in the control group.Considering the quadruple block, instead of AABB code 0, instead of ABAB code 1, give ABBA code 2, BAAB code 3, BBAA code 4 and BABA code 5 to 9. Then, using the table of random numbers, we randomly select the starting point and then consider 21 numbers as rows or columns. Whatever number we encounter, we replace the corresponding permutation.Finally, by selecting 21 items from the table, a total of 138 people will be divided into two groups, Blinding description: After selecting the samples, the study participants, the endoscopist, and the principal investigator are unaware of the allocation, and the drugs are injected by an anesthesiologist who is aware of the allocation, and the data are collected by them. 3 Endoscopy,Sedation. Intervention 1: Intervention group:The intervention group will receive Propofol 0.5 mg/kg and Ketamine 0.5 mg/kg, intravenous Lidocaine 2% 1.5 mg/kg made in Daroupakhsh company in Iran. Intervention 2: Control group: The control group will receive propofol 0.5 mg/kg and ketamine 0.5 mg/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 Hossein Keshavarzi
Emamkhomeini Hospital,Emamkhomein Street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 5677 8987 ghossein.hk@gmail.com Ahvaz University of Medical Sciences scientific Reza Akhondzadeh
Emamkhomeini Hospital,Emamkhomein Street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 2220118 rezaakh@hotmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Candidate patients under 18 to 65 years of age who are in groups 1 and 2 according to the American Society of Anesthesiology (ASA Class) 18 years 65 years Both Patients with severe heart or lung disease are not included in this study Patients with Renal failure are not included in this study Patients with Liver failure are not included in this study Patients allergic to Propofol, Ketamine, or Lidocaine are not included in this study T88.52 Failed moderate sedation during procedure Treatment - Drugs Treatment - Drugs Intervention group:The intervention group will receive Propofol 0.5 mg/kg and Ketamine 0.5 mg/kg, intravenous Lidocaine 2% 1.5 mg/kg made in Daroupakhsh company in Iran Control group: The control group will receive propofol 0.5 mg/kg and ketamine 0.5 mg/kg Total amount of Propofol consumed. Timepoint: From start to end of endoscopy. Method of measurement: Dose of drug. Level of sedation. Timepoint: From start to end of endoscopy. Method of measurement: Ramsay Sedation Scale. Amount of pain. Timepoint: From start to one hour after Endoscopy. Method of measurement: Visual Analogue Scale. Amount of Nausea and Vomiting. Timepoint: From start to end of Endoscopy. Method of measurement: Visual Analogue Scale. Time of recovery. Timepoint: From start to end of Endoscopy. Method of measurement: From end of endoscopy to full consciousness. Hemodynamic instability. Timepoint: From start to end of Endoscopy. Method of measurement: Amount of Heart rate, mean arterial pressure and blood oxygen saturation changes. Ahvaz University of Medical Sciences Approved 2021-10-19 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)