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IRCT20191208045659N1 IRCT 2019-12-28 Semnan University of Medical Sciences effect of Lavender essential oil and Alprazolam on anesthesia and hemodynamic parameters during general anesthesia process Compare the effectiveness of Lavender essential oil and Alprazolam on anesthesia and hemodynamic parameters during general anesthesia process 2020-01-04 anticipated 90 Complete https://irct.ir/trial/44139 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The current study aims to help expand the use of non-pharmacological methods in the anesthesia and surgery process, Randomization description: Using random number tables (random blocks A, B, C), patients are placed in one of intervention groups 1 (alprazolam), intervention group 2 (lavender scent) and group 3 (control group), Blinding description: Premeditation therapy with alprazolam for group 1 and aromatherapy for group 2, will be performed by the researcher in the morning of surgery day. The person who evaluating the depth of anesthesia and the statistical analyst does not know the type of pre-medication received by the patient or whether he is in the intervention or control group. 3 Condition 1: Fractures of various organs that are surgically repaired under anesthesia. Condition 2: Femoral neck fracture. Condition 3: Fracture of the bones of the right hand. Condition 4: Fracture of the bones of the left hand. Condition 5: Abdominal and gastrointestinal surgeries. Intervention 1: 2-3 hours before surgery premed will be administrated. For group 1, the dose of oral alprazolam is 0.5 mg. Intervention 2: Intervention group: 3 drops of lavender that is poured on a clean cloth or gauze and inhaled for 15-20 minutes. Intervention 3: Control group: As a control group, they receive only routine medications. Yes - There is a plan to make this available What will be shared: Baseline data of participants' such as age, sex, and kind of disease, intervention, and outcomes could be available to others through the publication of articles When: It is available to everyone indefinitely by publishing the article To whom: research center of Semnan University of Medical Sciences and researchers in the field of anesthesiology and intensive care could access the anonymous documentation by providing appropriate reasons. Conditions: The main finding data will be available to the public through articles. More detailed data will be made available to researchers and specialists through correspondence with the research team Where to obtain: By contact with the Correspond author in the published articles How to obtain: Introduce himself and mentioning personal, professional and organizational characteristics as well as the reasons for accessing to more detailed information and how to use this information. Comments: It seems that through the publication of the articles, the main research findings can be available to practitioners and researchers in anesthesiology and intensive care fields.
public Sefollah Alaei
Damghan Road, Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3514993437 +98 23 3365 4190 alaei@semums.ac.ir Semnan University of Medical Sciences scientific Abolfazl Abdullah Pour
Amin
Semnan Iran (Islamic Republic of) 3519735763 009831420 Ů‘Felordce@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Class I and II Anesthesia, Age group 15-60 years Not have serious illnesses and problems affecting body function and thermodynamics such as diabetes and cardiovascular disease 15 years 60 years Both History of mental illness or brain injury, current use of sedatives, opiates, psychotropics drugs, patients who do not cooperate, history of allergies or olfactory problems, pre- and inoperative body temperature rise, use of medications effective on sleep (such as phenobarbital) S72.04 S72.043 S62.91XA S62.92XA S39.91XA Fracture of base of neck of femur Displaced fracture of base of neck of unspecified femur Unspecified fracture of right wrist and hand Unspecified fracture of right wrist and hand Abdominal surgeries Treatment - Drugs Treatment - Drugs N/A 2-3 hours before surgery premed will be administrated. For group 1, the dose of oral alprazolam is 0.5 mg. Intervention group: 3 drops of lavender that is poured on a clean cloth or gauze and inhaled for 15-20 minutes. Control group: As a control group, they receive only routine medications The depth of anesthesia is evaluated peroperation and immediately after surgery. Timepoint: Depth of anesthesia during surgery for 3 times will be assessed. The assessment time is in starting of surgery, mid-surgery and finishing the last part of surgery and also after surgery, 5 minutes after being placed on the recovery bed . Method of measurement: Depth of anesthesia is measured by the Bispectral index (BIS) device. The patient's blood pressure is also measured using a digital blood pressure monitor. Vital sign include the patient's breathing, pulse rate and blood pressure measured by the assessor as well as with the help of a digital Sphygmomanometer. Timepoint: Vital signs will be measured before prescription medication, 5 minutes after surgery, before anesthesia, at the time of surgery, mid-surgery, and after the last part of the surgical intervention. . It will be also measured 5 minutes after surgery on the recovery bed. Method of measurement: By the assessor as well as with the help of a digital Sphygmomanometer. Semnan University of Medical Sciences Approved 2019-11-18 Semnan University of Medical Sciences Ethics Committee Damghan Road, Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)