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IRCT20200818048445N1 IRCT 2020-10-28 Ahvaz University of Medical Sciences A Comparison between the sedative effect of Fentanyl and Ketamine outside the operating room. A Comparison between the effect of Propofol Fentanyl and Propofol Ketamine on Colonoscopy patients' sedation. 2020-04-18 anticipated 144 Complete https://irct.ir/trial/50428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects were randomly divided into two groups based on the method of four random blocks.The site www.sealedenvelope.com was used for randomization.If we call the two groups A and B, the logic of randomization is that we select as many samples from the 6 blocks, AABB, BAAB, BBAA, ABBA, ABAB and BABA, by (ie as n / 4)by placing them to reach the sample size, Blinding description: In order to double blind the study, the patient's degree of sedation is recorded according to a modified Ramsay standard during the procedure by another person who does not know the medication prescribed to the patient. 2-3 Pain management of patients referred for Colonoscopy and reduce their anxiety. Intervention 1: The first intervention group: The group receiving Propofol Fentanyl for sedation during Colonoscopy. Intervention 2: Intervention group 2: The group receiving Propofol Ketamine for sedation during Colonoscopy. Yes - There is a plan to make this available What will be shared: The Excel file contains the identification code, reference to the file number and the registered information, except for the documents that can be provided. When: 6 months after printing the results until 10 years later To whom: All those who officially correspond with the Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences Conditions: Documents can be used for systematic review studies and meta-analysis Where to obtain: Vice Chancellor for Research Ahvaz Jundishapur University How to obtain: After approval from the Vice Chancellor for Research, the data file will be provided to the Vice Chancellor and then the data will be shared with other researchers or emailed to them. Comments: The material and intellectual property of this project is with Ahvaz University of Medical Sciences
public Baghbanian reza
NO.123/1, 3d Phase, West Mordad St, Chamran Blvd, Kian Pars
Ahvaz Iran (Islamic Republic of) 6155644379 +98 61 3376 5834 hosseinpour.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Baghbanian reza
NO.123/1, West Mordad Ave, Chamran Blvd, Kiyan Pars
Ahvaz Iran (Islamic Republic of) 6155644379 +98 61 3376 5834 baghbanian-r@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) They are between 18 and 65 years old Patients are referred for colonoscopy procedure Classification of Group 1 and 2 American Society of Anesthesiologists (ASA Class I & II) are selected as inclusion criteria. 18 years 65 years Both the patient's unwillingness to participate in the study They are under 18 years old They are over 65 years old They have kidney failure They have liver failure They have chronic pain syndrome They are addicted They have any drug allergies They have cardiovascular disease They have a respiratory disease They have metabolic diseases They have a neurological disease They have difficult airways The patient is classified as ASA class 3 and 4 Contraindicated propofol ketamine or propofol fentanyl Treatment - Drugs Treatment - Drugs The first intervention group: The group receiving Propofol Fentanyl for sedation during Colonoscopy. Intervention group 2: The group receiving Propofol Ketamine for sedation during Colonoscopy. A score of 5 or 6 RAMSAY criteria in the questionnaire. RAMSAY sedation criteria including 6 scores is as follows: 1. Completely awake and anxious 2. Quiet and calm with enough cooperation 3. Asleep and wakes up with a verbal command 4. Asleep and woke up with mild stimulation, but gives a strong reaction to painful stimuli 5. Slow reaction to painful stimuli 6. Lack of reaction to painful stimuli. Timepoint: 5 minutes after the procedure, 10 minutes after the procedure, 15 minutes after the procedure. Method of measurement: Verbal measurement criteria. The amount of pain. Timepoint: Start of procedure , end of procedure and one hour after the end of the procedure. Method of measurement: The Ambesh criterion, which includes the following four-point grading questions: 1. No pain: Negative answer to questions about having pain 2. Mild: Positive answers to questions about having pain, but without any physical symptoms 3. Medium: Positive answers to questions about having pain and the appearance of physical symptoms or successive complaints of pain 4. Intensity: The patient verbally complains of severe pain or shows pain with frowning and upset in the face or turning away with hand or expressing fear. Recovery time. Timepoint: Recovery time is defined as fast (less than 5 minutes), medium (between 5 to 10 minutes) and slow (more than 15 minutes). Method of measurement: Patient's appropriate answers to questions. Nausea. Timepoint: Every 5 minutes. Method of measurement: It is expressed by the person herself/himself. Systolic blood pressure. Timepoint: Every 5 minutes. Method of measurement: Blood pressure monitor. Diastolic blood pressure. Timepoint: Every 5 minutes. Method of measurement: Blood pressure monitor. Heart beat. Timepoint: every 5 minutes. Method of measurement: Cardiac monitor. Arterial blood oxygen saturation. Timepoint: Every 5 minutes. Method of measurement: Respiratory monitor. Ahvaz University of Medical Sciences Approved 2020-04-13 Research Ethics Committee of Ahwaz Jundishapur University of Medical Sciences Golestan Hospital, Golestan BLVD Ahvaz Khouzestan Iran (Islamic Republic of)