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IRCT20160812029310N4 IRCT 2018-07-01 Esfahan University of Medical Sciences Effect of Ketofol and Fenofol on sedation and analgesia Comparison of Propofol and Ketamine Combination (Ketofol) and Propofol and Fentanyl combination (Fenofol) on sedation and analgesia in patients undergoing lumpectomy 2017-02-28 anticipated 64 Complete https://irct.ir/trial/31669 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients were randomly assigned to the two groups of Fenofol and Ketofol using random number table, Blinding description: All drugs are prepared and placed at the same volume and homogeneously into the syringes by the investigator. The hemodynamic changes (after the administration of each drug) are monitored and recorded. Moreover, the Participant, Care provider, Outcome assessor, and Data analyser are not aware of the drug type and the investigator will decipher the codes after data analysis. 2 Condition 1: sedation. Condition 2: analgesia. Intervention 1: Intervention group 1: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and attached standard monitoring devices including pulsoximetry, capnography, and electrocardiogram. Baseline vital signs are recorded and the drugs are administered firstly through bolus injection and after that through continuous infusion. In this group, propofol (manufactured by B.Braun company Germany) at the dose of 1 mg/kg plus ketamine (manufactured by Rotexmedica Germany) at the dose of 1 mg/kg are infused during 10 minutes. Mean blood pressure, heart rate and oxygen saturation are recorded 1, 3, 5, 10, 60 and 120 minutes after induction. Intervention 2: Intervention group 2: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and attached standard monitoring devices including pulsoximetry, capnography, and electrocardiogram. Baseline vital signs are recorded and the drugs are administered firstly through bolus injection and after that through continuous infusion. In this group, propofol (manufactured by B.Braun company Germany) at the dose of 1 mg/kg plus Fentanyl (manufactured by Rotexmedica Germany) at the dose of 1mcg/kg are infused during 10 minutes. Mean blood pressure, heart rate and oxygen saturation during 1, 3, 5, 10 minutes after induction and at 60 and 120 minutes are recorded. Yes - There is a plan to make this available What will be shared: Only registered symptoms can be published without mentioning the names of the participants. When: "Starting the access period 6 months after printing results" To whom: Only available to scholars working in academia and academia Conditions: Written request via email and university approval Where to obtain: By contacting corresponding author How to obtain: After the email is received by the applicant, it takes one week to agree    The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days. Comments:
public Behzad Nazemroaya
Ostandari
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3224 7233 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Ostandari
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3224 7233 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) The patients at the age of 15-70 years old ASAIII With breast cancer ASA I,II candidates for lumpectomy 15 years 70 years Female Difficult airway management mental disorder allergy to drugs head Injury Severe cardiovascular disease Severe pulmonary disease history of Epilepsy or Seizure Treatment - Drugs Treatment - Drugs Intervention group 1: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and attached standard monitoring devices including pulsoximetry, capnography, and electrocardiogram. Baseline vital signs are recorded and the drugs are administered firstly through bolus injection and after that through continuous infusion. In this group, propofol (manufactured by B.Braun company Germany) at the dose of 1 mg/kg plus ketamine (manufactured by Rotexmedica Germany) at the dose of 1 mg/kg are infused during 10 minutes. Mean blood pressure, heart rate and oxygen saturation are recorded 1, 3, 5, 10, 60 and 120 minutes after induction. Intervention group 2: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and attached standard monitoring devices including pulsoximetry, capnography, and electrocardiogram. Baseline vital signs are recorded and the drugs are administered firstly through bolus injection and after that through continuous infusion. In this group, propofol (manufactured by B.Braun company Germany) at the dose of 1 mg/kg plus Fentanyl (manufactured by Rotexmedica Germany) at the dose of 1mcg/kg are infused during 10 minutes. Mean blood pressure, heart rate and oxygen saturation during 1, 3, 5, 10 minutes after induction and at 60 and 120 minutes are recorded. Mean arterial pressure. Timepoint: Before and after the intervention, one, three, five, ten minutes after induction of anesthesia and then at 60 and 120 minutes. Method of measurement: Non invasive blood pressure Automated. Heart rate. Timepoint: Before and after the intervention, 1, 3, 5, 10 minutes after induction of anesthesia and then at 60 and 120 minutes. Method of measurement: Pulse oximetry device. Arterial oxygen saturation. Timepoint: Before and after the intervention, 1, 3, 5, 10 minutes after induction of anesthesia and then at 60 and 120 minutes. Method of measurement: Pulse oximetry device. Intensity of pain. Timepoint: At times 1, 3, 5, 10 minutes after induction of anesthesia and then at 60 and 120 minutes after induction of anesthesia. Method of measurement: Using criterion VAS. Esfahan University of Medical Sciences Approved 2017-06-28 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar jarib street, Azadi square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)