]>
IRCT20090129001615N5 IRCT 2020-11-26 Esfahan University of Medical Sciences Evaluation of sublingual sufentanil effect in laryngoscopy Evaluation of the effect of two dose of subligual Sufentanil on heart rate and blood pressure changes after laryngoscopy and endotracheal intubation 2020-08-10 anticipated 96 Complete https://irct.ir/trial/49023 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization is done by using SPSS software. We have 96 patients and we give them numbers from 1 to 96. Then we enter these numbers into the SPSS. This software divides the patients into three groups and each patient is assigned a specific random number. By these numbers each patient is in his own group. The unit of randomization is individualized, Blinding description: The physician who will collect the patient’s data and the statistician who will analyze data have no information about the study group assignments. The study drugs will be injected by similar syringes in volume and color and they also will be administered for patients after induction of anesthesia so the patients will have no information about the injected drugs. 3 Patients who need generalize anesthesia with tracheal intubation. Intervention 1: First intervention group receive sublingual Sufentanil 0.1 microgram per kilogram 3 minutes before anesthetic drug injection. Intervention 2: Second Intervention group receive sublingual Sufentanil 0.2 microgram per kilogram 3 minutes before anesthetic drug injection. Intervention 3: Control group receive sublingual normal saline before anesthetic drug injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Azim Honarman
Isfahan University of Medical Science, Hezarjarib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8008 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences scientific Azim Honarmand
School of Medicine Sciences, Isfahan University of Medical, Hezar Jerib Ave.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8008 honarmand@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) age: 18-65 Patients with grade 1 or 2 of American Society of Anesthesiologists (ASA) grading patient needed endotracheal intubation in general anesthesia 18 years 65 years Both Patients with heart failure disease Patients with renal failure disease Patients with hepatic failure disease Patients with airway anomalies Patients aged 18 to 65 years Patients with addiction to drugs Prevention Prevention Prevention First intervention group receive sublingual Sufentanil 0.1 microgram per kilogram 3 minutes before anesthetic drug injection. Second Intervention group receive sublingual Sufentanil 0.2 microgram per kilogram 3 minutes before anesthetic drug injection. Control group receive sublingual normal saline before anesthetic drug injection. Systolic blood pressure. Timepoint: Before intervation and 1, 3, 5 and 10 minutes after intervation. Method of measurement: Blood pressure manometer. Diastolic blood pressure. Timepoint: Before intervation and 1, 3, 5 and 10 minutes after intervation. Method of measurement: Blood pressure manometer. Heart rate. Timepoint: Before intervation and 1, 3, 5 and 10 minutes after intervation. Method of measurement: Heart monitoring. Arterial O2 saturation. Timepoint: Before intervation and 1, 3, 5 and 10 minutes after intervation. Method of measurement: Puls oximeter. ST interval and T wave changes. Timepoint: Before intervation and 1, 3, 5 and 10 minutes after intervation. Method of measurement: Electrocardiogram. Esfahan University of Medical Sciences Approved 2020-08-22 Ethics committee of Isfahan University of Medical Sciences Isfahan university of medical science, Hezarjarib Ave. Isfahan Isfehan Iran (Islamic Republic of)