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IRCT20090129001615N4 IRCT 2020-10-28 Esfahan University of Medical Sciences Comparison of the effect of two drug combinations: Etomidate-Sufentanil with Ketamine-Sufentanil-Midazolam during laryngoscopy Comparison of the effect of two drug combinations: Etomidate-Sufentanil with Ketamine-Sufentanil-Midazolam on changes in heart rate and blood pressure after laryngoscopy and endotracheal intubation 2020-09-22 anticipated 96 Complete https://irct.ir/trial/49060 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be performed using Random Allocation software version 2.0. Ninety-six patients will be divided into 8 blocks of 12 members. For example, the first block will be included 12 patients that will be ordered non sequentially. The unit of randomization will be individualized. For allocation concealment, the physician administering the study drugs will not be informed from sequence of group assignment, Blinding description: Blinding will be performed as such: The physician who will collect the patient’s data and the statistician who will analyze data, have no information from 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 general anesthesia with tracheal intubation. Intervention 1: Intervention group 1: Patients will receive Etomidate (10 cc ampoules, 2 milligrams per cc, made by Abu Reihan Pharmaceutical Company) in the amount of 0.3 milligrams per kilogram body weight and Sufentanil (5 microgram ampoules per milliliter, made by the service institute Razavi drug) in the amount of 0.1 micrograms per kilogram of body weight. Both drugs will be injected intravenously and at the beginning of induction of anesthesia. Intervention 2: Intervention group 2: Patients will receive Ketamine (50 milligrams per milliliter ampoule, made by Razavi Pharmaceutical Services Institute) in the amount of 0.5 milligrams per kilogram body weight, Sufentanil in the amount of 0.1 micrograms per kilogram body weight and Midazolam (5 milligrams per milliliter ampoule, made by Razavi Pharmaceutical Services Institute) in the amount of 0.07 milligrams per kilogram body weight. Both drugs will be injected intravenously and at the beginning of induction of anesthesia. Intervention 3: Control group: Patients will receive Etomidate in the amount of 0.3 milligrams per kilogram body weight as well as normal saline (manufactured by Samen Pharmaceutical Company) as a placebo. Both will be injected intravenously and at the beginning of induction anesthesia. Yes - There is a plan to make this available What will be shared: There is no collected data yet. After collecting patients' information and making patient’s identities unrecognizable, all the information will be published in an article. When: Since the publication of the article To whom: Researchers working in academic, scientific and industrial institutes Conditions: Data publication will be done for additional statistical analysis after verifying the validity of the research center or the researcher who has requested the data. Where to obtain: Dr Azim Honarmand honarmand@med.mui.ac.ir How to obtain: The request for data will be answered 1 to 2 weeks after receiving email from the research center or the researcher. Comments:
public Azim Honarmand
Isfahan University of Medical, School of Medicine Sciences, Hezar Jerib 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) Patients with ASA (American Society of Anesthesiologists) grade:1 or 2 Patients aged 18 to 65 years Patients who need tracheal intubation and general anesthesia 18 years 65 years Both Patients with heart failure disease Patients who are addicted to drugs Patients with airway anomalies Patients with hepatic failure disease Patients with renal failure disease Patients with over 65 years or under 18 years Prevention Prevention Prevention Intervention group 1: Patients will receive Etomidate (10 cc ampoules, 2 milligrams per cc, made by Abu Reihan Pharmaceutical Company) in the amount of 0.3 milligrams per kilogram body weight and Sufentanil (5 microgram ampoules per milliliter, made by the service institute Razavi drug) in the amount of 0.1 micrograms per kilogram of body weight. Both drugs will be injected intravenously and at the beginning of induction of anesthesia. Intervention group 2: Patients will receive Ketamine (50 milligrams per milliliter ampoule, made by Razavi Pharmaceutical Services Institute) in the amount of 0.5 milligrams per kilogram body weight, Sufentanil in the amount of 0.1 micrograms per kilogram body weight and Midazolam (5 milligrams per milliliter ampoule, made by Razavi Pharmaceutical Services Institute) in the amount of 0.07 milligrams per kilogram body weight. Both drugs will be injected intravenously and at the beginning of induction of anesthesia. Control group: Patients will receive Etomidate in the amount of 0.3 milligrams per kilogram body weight as well as normal saline (manufactured by Samen Pharmaceutical Company) as a placebo. Both will be injected intravenously and at the beginning of induction anesthesia. Systolic blood pressure mean in each group. Timepoint: Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Blood pressure manometer. Diastolic blood pressure mean in each group. Timepoint: Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Blood pressure manometer. Heart rate mean in each group. Timepoint: Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Heart monitoring device. Arterial oxygen saturation mean in each group. Timepoint: Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Pulse oximeter. Electrocardiogram ST-T changes relative frequency in each group. Timepoint: Before intervention and 1, 3, 5 and 10 minutes after laryngoscopy. Method of measurement: Electrocardiogram. Esfahan University of Medical Sciences Approved 2020-08-31 Ethics committee of Isfahan University of Medical Sciences Hezarjerib Ave. Isfahan Isfehan Iran (Islamic Republic of)