]>
IRCT20170624034726N2 IRCT 2020-02-10 Esfahan University of Medical Sciences Effects of remifentanil on recovery conditions among healthy children Effects of remifentanil on recovery conditions among healthy children candidate for dentistry under general anesthesia 2020-04-19 anticipated 100 Complete https://irct.ir/trial/44032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals who are eligible for inclusion will be divided into two groups using simple random method. Individuals will be randomly assigned to remifentanil or propofol by an expert. All the study subjects and the original researcher will be unaware of the existing grouping until the end of the study, and the assignment will be performed by another person who has no knowledge of the research process. The anesthetist will inject the medications, Blinding description: This study will be a double blind study. Drugs injection will be done by anesthesiologist and assessor of recovery conditions and participants will not aware of type of drug used for anesthesia maintenance. 3 Condition 1: Recovery condition. Condition 2: Patient discharge time. Condition 3: Blood pressure. Intervention 1: Intervention group: Anesthesia induction in both intervention and control groups will be performed using 5 mg/kg sodium thiopental, 1 μg/kg fentanyl and 0.6 μg/kg atracurium. Then, the patient will be connected to an anesthesia machine with a respiratory rate of 10 cc/kg and a respiratory rate of 15 cc. The volume and number of breaths will be controlled using a capnograph. The intervention group will received remifentanil 0.4 µg/kg and then 1 µg/kg for initial loading, 100 µg/kg propofol and 50% N2O and 50% oxygen. Intervention 2: Control group: To anesthesia maintenance, the control group will receive 100 μg/kg propofol and then 1 μg/kg for initial loading, 50% N2O and 50% oxygen. 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 There is no further information.
public Nosrat Nourbakhsh
Isfahan University of Medical Sciences, Hezar Jerib avenue
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5591 Nourbakhsh@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Nosrat Nourbakhsh
Isfahan University of Medical Sciences, Hezar Jerib avenue
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5591 Nourbakhsh@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study 3-6 years old children Referred for dental practices under general anesthesia Lack of any special disease Lack of allergy to anesthesia drugs Lack of any previous experience of anesthesia 3 years 6 years Both Chronic diseases such as hepatic or kidney diseases cardiovascular diseases hemorrhagic diseases overweight and obese children children with cerebral palsy use of sedative drugs that interfere with agitation R03.0 Elevated blood-pressure reading, without diagnosis of hypertension Treatment - Drugs Treatment - Drugs Intervention group: Anesthesia induction in both intervention and control groups will be performed using 5 mg/kg sodium thiopental, 1 μg/kg fentanyl and 0.6 μg/kg atracurium. Then, the patient will be connected to an anesthesia machine with a respiratory rate of 10 cc/kg and a respiratory rate of 15 cc. The volume and number of breaths will be controlled using a capnograph. The intervention group will received remifentanil 0.4 µg/kg and then 1 µg/kg for initial loading, 100 µg/kg propofol and 50% N2O and 50% oxygen. Control group: To anesthesia maintenance, the control group will receive 100 μg/kg propofol and then 1 μg/kg for initial loading, 50% N2O and 50% oxygen. Recovery conditions. Timepoint: After leaving operating room. Method of measurement: Questionnaire. Patient discharge time. Timepoint: After leaving operating room. Method of measurement: Questionnaire. Blood pressure. Timepoint: After leaving operating room. Method of measurement: Digital sphygmomanometer. Esfahan University of Medical Sciences Approved 2019-07-12 Ethic committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Avenue Isfahan Isfehan Iran (Islamic Republic of)