]>
IRCT20180416039326N17 IRCT 2020-12-10 Esfahan University of Medical Sciences Effect of Ketamine on Sedation in Bronchoscopy Comparison of the Effect of Three Different Ketamine doses on Quality of Sedation in Bronchoscopy 2020-11-21 anticipated 90 Complete https://irct.ir/trial/51454 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into three groups based on the table created by randomization software (Randomization and Minimization). Randomization is performed by an expert who is not a member of the research team, and each code will be stored in a sealed envelope until the end of the study. On the day of surgery, patients enter the operating room based on the numbers assigned to them, Blinding description: On the day of surgery, patients enter the operating room based on the numbers assigned to them. The medications will be prepared and injected by an anesthesiologist who has no role in collecting the information. An observer who is unaware of the grouping of patients and prescribes drugs records the results of the study. 2-3 Bronchoscopy. Intervention 1: Intervention group 1 (The first group of Ketamine 0.2 mg/kg): Propofol 1.5 mg/kg is drawn into the pump syringe and according to the grouping, Ketamine is added to Propofol and the syringe volume is reduced to 15 ml. Sedation is started by gradual bolus injection of 50-100mcg / kg Propofol based on pump syringe Reaching the desired sedation level 3 based on Ramsey Continuation of sedation continues at an infusion rate of 50-100mcg / kg Propofol. If more sedation is needed, 0.5 mg / kg Propofol (5 mg/ml) will be injected in all three groups. If you feel pain during the procedure in all three groups of Fentanyl 1mcg / kg and if you feel pain in recovery, Apotel will be used at a dose of 15 mg/kg. Intervention 2: Intervention group 2 (the second group of ketamine 0.4 mg/kg): Propofol 1.5 mg / kg is drawn into the pump syringe and according to the grouping, Ketamine is added to Propofol and the syringe volume is reduced to 15 ml.Sedation is started by gradual bolus injection of 50-100mcg / kg Propofol based on pump syringe Reaching the desired sedation level 3 based on Ramsey Continuation of sedation continues at an infusion rate of 50-100mcg / kg Propofol.If more sedation is needed, 0.5 mg / kg Propofol (5 mg / ml) will be injected in all three groups. If you feel pain during the procedure in all three groups of Fentanyl 1mcg / kg and if you feel pain in recovery, Apotel will be used at a dose of 15 mg / kg. Intervention 3: Intervention group 3 (the third group of ketamine 0.5mg / kg): Propofol 1.5 mg / kg is drawn into the pump syringe and according to the grouping, Ketamine is added to Propofol and the syringe volume is reduced to 15 ml.Sedation is started by gradual bolus injection of 50-100mcg / kg Propofol based on pump syringe Reaching the desired sedation level 3 based on Ramsey Continuation of sedation continues at an infusion rate of 50-100mcg / kg Propofol.If more sedation is needed, 0.5 mg / kg Propofol (5 mg / ml) will be injected in all three groups. If you feel pain during the procedure in all three groups of Fentanyl 1mcg / kg and if you feel pain in recovery, Apotel will be used at a dose of 15 mg / kg. Yes - There is a plan to make this available What will be shared: Data include sedation and hemodynamic indices and complications in all three intervention groups after unidentifiable individuals can be shared. When: 6 months after publication of paper To whom: Academic and medical researchers Conditions: Use for research and treatment purposes Where to obtain: Email of the person in charge of public accountability: Hamidshetabi@med.mui.ac.ir How to obtain: Upon request, it will be sent via email if available within a maximum of 1 month Comments:
public Hamidraza Shetabi
Al-Zahra Hospital; Sofe bolevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Hamidraza Shetabi
Al-Zahra Hospital; Sofe bolevard
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 hamidshetabi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for Bronchoscopy Being at the age over 18 years old Patients whit ASA class 1 and 2 18 years no limit Both Patient disinclination Mental disorders History of chronic sedative drug use Opioid and alcohol use disorders History of any allergy to any medications use in the study Take sedative or analgesics 24 hours before the procedure Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1 (The first group of Ketamine 0.2 mg/kg): Propofol 1.5 mg/kg is drawn into the pump syringe and according to the grouping, Ketamine is added to Propofol and the syringe volume is reduced to 15 ml. Sedation is started by gradual bolus injection of 50-100mcg / kg Propofol based on pump syringe Reaching the desired sedation level 3 based on Ramsey Continuation of sedation continues at an infusion rate of 50-100mcg / kg Propofol. If more sedation is needed, 0.5 mg / kg Propofol (5 mg/ml) will be injected in all three groups. If you feel pain during the procedure in all three groups of Fentanyl 1mcg / kg and if you feel pain in recovery, Apotel will be used at a dose of 15 mg/kg. Intervention group 2 (the second group of ketamine 0.4 mg/kg): Propofol 1.5 mg / kg is drawn into the pump syringe and according to the grouping, Ketamine is added to Propofol and the syringe volume is reduced to 15 ml.Sedation is started by gradual bolus injection of 50-100mcg / kg Propofol based on pump syringe Reaching the desired sedation level 3 based on Ramsey Continuation of sedation continues at an infusion rate of 50-100mcg / kg Propofol.If more sedation is needed, 0.5 mg / kg Propofol (5 mg / ml) will be injected in all three groups. If you feel pain during the procedure in all three groups of Fentanyl 1mcg / kg and if you feel pain in recovery, Apotel will be used at a dose of 15 mg / kg. Intervention group 3 (the third group of ketamine 0.5mg / kg): Propofol 1.5 mg / kg is drawn into the pump syringe and according to the grouping, Ketamine is added to Propofol and the syringe volume is reduced to 15 ml.Sedation is started by gradual bolus injection of 50-100mcg / kg Propofol based on pump syringe Reaching the desired sedation level 3 based on Ramsey Continuation of sedation continues at an infusion rate of 50-100mcg / kg Propofol.If more sedation is needed, 0.5 mg / kg Propofol (5 mg / ml) will be injected in all three groups. If you feel pain during the procedure in all three groups of Fentanyl 1mcg / kg and if you feel pain in recovery, Apotel will be used at a dose of 15 mg / kg. Sedation level based on Ramsay score. Timepoint: During the operation every 5 minutes and then in recovery room every 15 minutes, until recovery from recovery room. Method of measurement: questionnaire. Heart Rate. Timepoint: Before the operation, During the operation every 5 minutes and then in recovery every 15 minutes, until recovery from recovery. Method of measurement: monitoring. Systolic blood pressure. Timepoint: Before the operation, During the operation every 5 minutes and then in recovery every 15 minutes, until recovery from recovery. Method of measurement: monitoring. Diastolic blood pressure. Timepoint: Before the operation, During the operation every 5 minutes and then in recovery every 15 minutes, until recovery from recovery. Method of measurement: monitoring. Mean Atrial Pressure. Timepoint: Before the operation, During the operation every 5 minutes and then in recovery every 15 minutes, until recovery from recovery. Method of measurement: monitoring. Percentage of arterial oxygen saturation. Timepoint: Before the operation, During the operation every 5 minutes and then in recovery every 15 minutes, until recovery from recovery. Method of measurement: monitoring. Complications during the procedure (hypo tension, hypertension, tachycardia, bradycardia, pain ...). Timepoint: During the operation every 5 minutes minutes. Method of measurement: questionnaire. Complications in recovery (vomiting nausea ...). Timepoint: in recovery every 15 minutes, until recovery from recovery. Method of measurement: questionnaire. Duration of stay in recovery. Timepoint: per minutes. Method of measurement: questionnaire. Esfahan University of Medical Sciences Approved 2020-11-09 Ethics committee of Isfahan University of Medical Sciences Al-Zahra Hospital; Sofe bolevard Isfahan Isfehan Iran (Islamic Republic of)