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IRCT20121204011662N13 IRCT 2020-02-17 Shiraz University of Medical Sciences Comparison of quality anesthesia of two anesthetic drugs in direct laryngoscopy. Comparison of Dexmedetomidine and Remifentanil in the Anesthesia for Direct Laryngoscopy: A Randomized Clinical Trial 2020-01-20 anticipated 60 Complete https://irct.ir/trial/44260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients will be randomly allocated into two groups A & B, according to randomization numbers table using quadratic permutation blocks that will derive from randomization.org, Blinding description: For blindness, All of the drugs solution( dexmedetomidine and remifentanil) of this study will be prepared in 20 ml syringes that are similar and equal in shape , by a nurse of anesthesia who aware of patients' study's groups.These syringes will have label A or B. Anesthesiologist who will use these syringes will not aware of the content of this syringes, just use syringes with label A for patients in group A and syringes with label B for patients in group B. Patients and all medical stuffs who will collaborate in data gathering , will not aware of the content of this syringes. 3 Survey of anesthesia for direct laryngoscopy.. Intervention 1: Intervention group 1: After induction of anesthesia,patients in group Awill be received an IV infusion of dexmedetomidine 1 mcg/Kg over five minutes with a 20 ml syringe with the label A. Intervention 2: Intervention group 2: After induction of anesthesia,patients in group B will be received an IV infusion of remifentanyl 1 mcg/Kg over five minutes with a 20 ml syringe with the label B. 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 MohammadAli Sahmeddini
Anesthesia Department, Operation Room, Nemazee Hospital, Nemazee Square, Zand Blvd
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 sahmeddin@sums.ac.ir Shiraz University of Medical Sciences scientific MohammadAli Sahmeddini
Anesthesia Department, Operation Room, Nemazee Hospital, Anesthesia and Critical Research Center
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 sahmeddini@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) All patients who will candidate for direct laparoscopy under general anesthesia will be enrolled. 20 years 70 years Both Patients with history of ischemic heart disease Patients with history of heart failure Patients with history of asthma Patients with history of renal failure Patients with history of hepatic failure Patients who are morbidly obese Patients in emergency situation Treatment - Drugs Treatment - Drugs Intervention group 1: After induction of anesthesia,patients in group Awill be received an IV infusion of dexmedetomidine 1 mcg/Kg over five minutes with a 20 ml syringe with the label A. Intervention group 2: After induction of anesthesia,patients in group B will be received an IV infusion of remifentanyl 1 mcg/Kg over five minutes with a 20 ml syringe with the label B. Mean arterial blood pressure (MAP). Timepoint: Values will record at baseline, 5, 10, 15, 30, and 45, minutes. Method of measurement: Non invasive blood pressure monitoring. Heart rate per minute. Timepoint: Values will record at baseline, 5, 10, 15, 30, and 45, minutes. Method of measurement: Electrocardiogram. Sedation Score. Timepoint: Every 15 minutes in recovery room. Method of measurement: Ramsay Scale. Attacks of respiratory depression. Timepoint: Every 15 minutes in recovery room. Method of measurement: Defined as a respiratory rate < 8 breaths/min. Incidence of nausea and vomiting. Timepoint: Every 15 minutes in recovery room. Method of measurement: 0: No nausea and vomiting, 1: Nuasea without Vomiting, 2: Both Nausea and Vomiting. Severity of postoperative pain. Timepoint: Every 15 minutes in recovery room. Method of measurement: Visual analogue Scale. Shiraz University of Medical Sciences Approved 2019-12-16 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)