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IRCT20201028049177N1 IRCT 2021-05-24 Mashhad University of Medical Sciences Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants 2019-03-19 anticipated 50 Complete https://irct.ir/trial/53689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects will be randomly assigned into two groups of 25 patients with categories of 2 using the randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the 2 intervention and control groups, Blinding description: Participants and intubation technicians were initially informed of the study process and its contents, but were unaware that participants were in the intervention or control groups. 3 Comparison of the effect of dexmedetomidine and atracurium in the ease of the tracheal after induction with propofol and sufentanil in children aged 6 to 12 years without neuromuscular relaxants. Intervention 1: Dexmedotidine group (A) and atracurium group (B). Patients in group A receive the following: Dexmedotidine 1 μg / kg + Propofol (3 mg / kg) + Su fentanyl (0.3 μg / kg). Intervention 2: Control group: Patients in group B will receive atracurium 0.5 mg / kg + propofol (3 mg / kg) + su fentanyl (0.3 μg / kg). Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome When: Access period starts one year after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: Only for researchers working in academic and scientific institutions Where to obtain: Email How to obtain: 2 months after receiving the application Comments:
public DR. Mohammad Alipour
Mashhad, Ghaem hospital, Department of Anesthesia and Critical care
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 7402 alipourm@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Alipour Mohammad
Mashhad, Ghaem hospital, Department of Anesthesia and Critical care
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3841 7402 alipourm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between six to twelve years Candidates for tracheal intubation under general anesthesia who are candidates for elective surgery Asa physical condition score one and two Consent of the patient's guardian or legal guardian to enter the study 6 years 12 years Both Respiratory tract infection three weeks before intubation Children with cardiovascular disease Children have a difficult airway for intubation Children with morbid obesity (weight to height ratio more than 20%) Children with neuromuscular diseases Dissatisfaction of parents or legal guardians of patients to enter the study T88.4 Failed or difficult intubation Treatment - Drugs Treatment - Drugs Dexmedotidine group (A) and atracurium group (B). Patients in group A receive the following: Dexmedotidine 1 μg / kg + Propofol (3 mg / kg) + Su fentanyl (0.3 μg / kg) Control group: Patients in group B will receive atracurium 0.5 mg / kg + propofol (3 mg / kg) + su fentanyl (0.3 μg / kg) Success rate in intubation. Timepoint: before intervention and 1 min after intervention. Method of measurement: Ease of intubation based on scoring table and intubation anesthesia partner checklist. Vital signs were recorded by monitoring. Includes sphygmomanometer .Pulse oximetry .Electrocardiogram. Success rate in intubation in two groups/Hemodynamic responses. Timepoint: At zero time: before induction time one after induction and before intubation and time two one minute after intubation. Method of measurement: Scoring table / monitoring of blood pressure, heart rate and pulse oximetry. Secondary outcomes include hemodynamic responses at time zero: before induction, time one after induction and before intubation, and two minutes one minute after intubation measured in both groups and the incidence of complications in both groups and scoring the intubation status (scoring). Timepoint: before intervention and 1 min after intervention. Method of measurement: the scoring method. Mashhad University of Medical Sciences Approved 2019-06-18 Ethics committee of Mashhad University of medical Sciences Razavi Khorasan Province, Mashhad, Ahmadabad Blvd, Department of Anesthesia and critical care, Dr. Mohammad Alipor mashhad Razavi Khorasan Iran (Islamic Republic of)