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IRCT20200825048515N13 IRCT 2020-12-03 Esfahan University of Medical Sciences Comparing the effect of "ketamine-midazolam" with "ketamine-dexmedetomidine" on hemodynamic changes in patients candidate for fiberoptic bronchoscopy Comparative study of the effect of "ketamine-midazolam" with "ketamine-dexmedetomidine" on sedation, pain, and hemodynamic changes in patients candidate for fiberoptic bronchoscopy 2020-10-22 anticipated 66 Complete https://irct.ir/trial/51643 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In a double-blind trial, two drug-combinations will be prepared by the anesthesiologist before the intervention begins. All medicines will be provided in the same volume with the aid of distilled water. These syringes will be labeled and given to the researcher on a daily basis, and they will be administered without knowing the type of each drug. In addition, the patient (due to lack of consciousness) will not know the type of intervention. The statistical analyst will not be aware of the type of intervention. 2-3 Bronchoscopy. Intervention 1: First intervention group: First, for all patients, 2% lidocaine(Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the first intervention group receive 1 mg/kg ketamine(Caspian-Tamin Company) and 1 μg/kg dexmedetomidine(Caspian-Tamin Company) for 10 minutes and the infusion of 0.5 mg/min ketamine and 0.5 μg/kg dexmedetomidine. Intervention 2: Second intervention group: First, for all patients, 2% lidocaine (Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the second group receive 1 mg/kg ketamine (Caspian-Tamin Company) and 2.5 mg midazolam (Caspian-Tamin Company) over ten minutes and are also given an infusion of 0.5 mg/min ketamine and a 25% starting dose of midazolam. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Behzad Nazemroaya
Anesthesiology Department, Hezar Jerib Street, Al-Zahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Anesthesiology Department, Al-Zahra Hospital, Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients candidate for bronchoscopy The American Society of Anesthesiologists (ASA) Physical Status Classification equal I or II Being consent to participate in the study 18 years 60 years Both Taking painkillers and opioids 24 hours before surgery Taking beta-blockers before the study Allergy to medications Asthma History of cardiovascular disease History of kidney disease History of liver disease History of chronic respiratory disease History of immunodeficiency Consuming alcohol 24 hours before surgery People with heart block and conduction disorders Having muscle weakness Treatment - Drugs Treatment - Drugs First intervention group: First, for all patients, 2% lidocaine(Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the first intervention group receive 1 mg/kg ketamine(Caspian-Tamin Company) and 1 μg/kg dexmedetomidine(Caspian-Tamin Company) for 10 minutes and the infusion of 0.5 mg/min ketamine and 0.5 μg/kg dexmedetomidine. Second intervention group: First, for all patients, 2% lidocaine (Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the second group receive 1 mg/kg ketamine (Caspian-Tamin Company) and 2.5 mg midazolam (Caspian-Tamin Company) over ten minutes and are also given an infusion of 0.5 mg/min ketamine and a 25% starting dose of midazolam. Sedation level. Timepoint: Two minutes after bolus injection. Method of measurement: Ramsay Sedation Scale. Pain. Timepoint: Immediately, 10, 20 and 30 minutes after consciousness. Method of measurement: Visual Analog Scale (VAS). Blood pressure. Timepoint: Before the intervention, immediately, 10, 20 and 30 minutes after the intervention. Method of measurement: Monitoring device. Heart rate. Timepoint: Before the intervention, immediately, 10, 20 and 30 minutes after the intervention. Method of measurement: Monitoring device. Oxygen saturation percentage (SPO2). Timepoint: Before the intervention, immediately, 10, 20 and 30 minutes after the intervention. Method of measurement: Monitoring device. Isfahan University of Medical Sciences Approved 2020-08-08 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave, Azadi Square. Isfahan Isfehan Iran (Islamic Republic of)