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IRCT20190714044207N1 IRCT 2019-07-25 Zahedan University of Medical Sciences The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018 ZSGIE The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018 2017-03-21 anticipated 140 Complete https://irct.ir/trial/40829 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Selection and assignment of samples to each treatment group is done by random blocking method. The number of cards in each block will be in the case and control groups, the arrangement of each card of the groups in the block, taking into account the random order with the examples of the permutations, will be arranged, Blinding description: Patients, Anesthetist, Gastroenterologist are unaware of the allocation of study groups. N/A Condition 1: The sedative effect of the medication on endoscopic digestive system. Condition 2: The sedative effect of the medication on endoscopic digestive system. Intervention 1: Intervention group: IV infusion of midazolam + fentanyl (F), midazolam, mcg / kg 15, fentanyl 0.15 mg / kg. Intervention 2: Intervention group:IV infusion of midazolam + propofol (P ) Midazolam 15mcg / kg and Propofol 1mg / 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 No more information
public Doctor Sakineh Sheikh
Salamat Blvd., Persian Gulf Highway, Zahedan
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5715 sakine.sheikh@gmail.com Zahedan University of Medical Sciences scientific Sakineh Sheikh
Third Intersection, No. 12 Shahid Barfi street, Shahid Barfi Ave
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3343 4621 mmahjoubifard@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Patient candidated for upper GI endoscopy 20-70 years old ASA class ≤3 20 years 70 years Both Heart disease AS، IHD ، HTN،(HF EF<30%) Liver disease (Child-Pugh classification C) Renal disease (GFR<60%) Lack of patient cooperation Psychiatric Disease (Major Depression, Mania, Psychosis) SBP<90 Addiction Emergent endoscopy Allergy to egg and soybean R10 R19 Abdominal and pelvic pain Other symptoms and signs involving the digestive system and abdomen Treatment - Drugs Treatment - Drugs Intervention group: IV infusion of midazolam + fentanyl (F), midazolam, mcg / kg 15, fentanyl 0.15 mg / kg Intervention group:IV infusion of midazolam + propofol (P ) Midazolam 15mcg / kg and Propofol 1mg / kg Sedation of drugs in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Ramsay sedation score (0-5). The number of respiration in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device. The number of heart rate in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device. Blood Pressure in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device. Arterial oxygen saturation in both groups before and after endoscopy. Timepoint: From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room. Method of measurement: Vital signs Monitor device. Comparison of vital signs after endoscopy. Timepoint: When the patient is transferred to the recovery room. Method of measurement: Monitoring device of vital signs. The satisfaction of sefation of two drug regimens. Timepoint: After Endoscopy End. Method of measurement: Anesthesiology Resident Skill and Experience. Zahedan University of Medical Sciences Approved 2019-01-26 Ethics committee of Zahedan University of Medical Sciences ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)