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IRCT20200825048515N57 IRCT 2022-08-28 Esfahan University of Medical Sciences Investigating the effect of dexmedetomidine on recovery indicators after rhinoplasty surgery Investigating the preventive effect of dexmedetomidine infusion on recovery indicators after rhinoplasty surgery under general anesthesia 2022-08-23 anticipated 60 Complete https://irct.ir/trial/64789 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 eligible patients are randomly selected. Then the letters A, B and C are written on 20 sheets and each one is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of three groups, Blinding description: In order to achieve the triple-blind study, different doses of Dexmedetomidine and placebo will be prepared daily by the operating room nurse (without the researcher's awareness) and placed in the bag and will be labeled A, B, C, and D. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention. 3 Rhinoplasty. Intervention 1: Control group: half an hour before the end of the surgery, normal saline will be administered in the same volume as the intervention groups in the form of bolus and infusion. Intervention 2: The first intervention group: Half an hour before the end of the surgery, dexmedetomidine 1 microgram/kg bolus dose will be prescribed within 10 minutes, and then half microgram/kg infusion and continue until 30 minutes after recovery. Intervention 3: The second intervention group: Half an hour before the end of the surgery, 1 microgram/kg bolus dose will be prescribed within 10 minutes, then 0.7 microgram/kg infusion and continue until 30 minutes after entering recovery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Azim Honarmand
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 honarmand@med.mui.a.ir Esfahan University of Medical Sciences scientific Azim Honarmand
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 honarmand@med.mui.a.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age range18 to 65 years Rhinoplasty surgery candidate under general anesthesia American Society of Anesthesiology (ASA) class one and two Consent to participate in the study 18 years 65 years Both Addiction The history of previous allergy to dexmedetomidine body mass index (BMI) above 30 kg/m2 Taking painkillers or neuropsychiatric drugs before the intervention J34 Other and unspecified disorders of nose and nasal sinuses Placebo Treatment - Drugs Treatment - Drugs Control group: half an hour before the end of the surgery, normal saline will be administered in the same volume as the intervention groups in the form of bolus and infusion. The first intervention group: Half an hour before the end of the surgery, dexmedetomidine 1 microgram/kg bolus dose will be prescribed within 10 minutes, and then half microgram/kg infusion and continue until 30 minutes after recovery. The second intervention group: Half an hour before the end of the surgery, 1 microgram/kg bolus dose will be prescribed within 10 minutes, then 0.7 microgram/kg infusion and continue until 30 minutes after entering recovery. Pain. Timepoint: Immediately after entering recovery and then every 15 minutes until leaving recovery. Method of measurement: Visual Analogue Scale. Chilling. Timepoint: Immediately after entering recovery and then every 15 minutes until leaving recovery. Method of measurement: Based on the shivering criterion (0: no shivering / 1: weak fasciculation of face and neck muscles / 2: visible tremor in more than one muscle group). Restlessness. Timepoint: Immediately after entering recovery and then every 15 minutes until leaving recovery. Method of measurement: Riker sedation-agitation scale. Nausea. Timepoint: Immediately after entering recovery and then every 15 minutes until leaving recovery. Method of measurement: 0: not having nausea, 1: mild nausea, 2: moderate nausea, and 3: sever nausea. Vomiting. Timepoint: Immediately after entering recovery and then every 15 minutes until leaving recovery. Method of measurement: 0: no vomiting, 1: little vomiting, 2: vomiting gastric contents, and 3: vomiting of food particles. Isfahan University of Medical Sciences Approved 2022-07-22 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)