]>
IRCT20160307026950N33 IRCT 2021-03-30 Esfahan University of Medical Sciences The effect of Fentanyl injection and Valsalva maneuver on pain caused by Etomidate injection Comparison of the effectiveness of Fentanyl administration and Valsalva maneuver in relieving pain caused by Etomidate injection to induce general anesthesia 2021-01-04 anticipated 96 Complete https://irct.ir/trial/51292 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, the two groups are compared in terms of intervention and the control group does not exist separately, Randomization description: Randomization is done by block method; If the number of patients in both groups is the same, the first patient enters one of the groups by lottery, then from the second patient, patients enter one of the groups one by one according to their arrival time, so that the sample size reaches the required number in each Reach the group, Blinding description: This is a randomized, double-blind clinical trial; Patients are explained that in order to reduce the pain caused by anesthesia injection, two interventions of Fentanyl injection and Valsalva maneuver are performed on them and depending on their group, only one of the interventions is performed completely, but patients are of the intervention type. The one who will be fully applied are unaware. Also, the person injecting the drug and the person recording the patient's symptoms are unaware of the type of intervention applied. The data is encrypted and therefore the analyzers are also blind. 3 The pain caused by injection of Etomidate. Intervention 1: Intervention group A: In this group, patients first receive 2 cc of normal saline intravenously and after 3 minutes, perform the Valsalva maneuver by blowing in a plastic tube (where the hole is closed on the tube) for at least 26 seconds. At the end of the Valsalva maneuver, Etomidate injection is started. Intervention 2: Intervention group B: Patients in this group first receive Fentanyl at a dose of 2 micrograms per kilogram of body weight intravenously and 3 minutes later a plastic tube is placed in the patient's mouth and the patient blows into the tube (while the hole is inserted on Is open on the pipe). Etomidate injection is started after 26 seconds. 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 more information
public Golshan Mazahery
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 www.g.mazaheri@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemoroaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 65 years Candidate for General Anesthesia ASA Class I and II Anesthesia Able to perform Valsalva maneuver 18 years 65 years Both History of mental, Cardiorespiratory and chronic pain disorders Use of painkillers History of allergy to Etomidate and Fentanyl History of drug use G89 Pain, not elsewhere classified Prevention Prevention Intervention group A: In this group, patients first receive 2 cc of normal saline intravenously and after 3 minutes, perform the Valsalva maneuver by blowing in a plastic tube (where the hole is closed on the tube) for at least 26 seconds. At the end of the Valsalva maneuver, Etomidate injection is started. Intervention group B: Patients in this group first receive Fentanyl at a dose of 2 micrograms per kilogram of body weight intravenously and 3 minutes later a plastic tube is placed in the patient's mouth and the patient blows into the tube (while the hole is inserted on Is open on the pipe). Etomidate injection is started after 26 seconds. The amount of pain caused by Etomidate injection. Timepoint: Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of Etomidate. Method of measurement: withdrawal response score. Blood Pressure. Timepoint: Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of atomidite. Method of measurement: Manometer. Heart Rate. Timepoint: Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of atomidite. Method of measurement: ECG. Blood oxygen saturation. Timepoint: Before intervention, after intervention, immediately after injection and 1, 2, 3, 5, 10 and 15 minutes after injection of initial dose of atomidite. Method of measurement: Pulse Oximeter. Vice Chancellor for Research, Isfahan University of Medical Sciences Approved 2020-08-22 Isfahan University of Medical Sciences Committe for Ethics in Biomedical Research Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)