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IRCT20200501047254N2 IRCT 2022-02-23 Gonabad University of Medical Sciences Evaluation of the Effect of Hypothermia Prevention Program in Children Undergoing Orthopedic Surgery Evaluation of the Effect of Hypothermia Prevention Program on, Recovery Time, Shivering and Hemodynamic Status in Pediatric Undergoing Orthopedic Surgery Under General Anesthesia 2022-03-06 anticipated 60 Complete https://irct.ir/trial/62017 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: The sampling method is simple randomization. For random allocation of participants, 60 envelopes are prepared and in each envelope the names of groups, A or B are placed evenly. Then the patient with the inclusion criteria randomly selects an envelope and according to the name of the group that if A was in the intervention group and if B was in the control group and until the last sample will be done in the same way and the necessary measures for the group Will be done, Blinding description: This study is a single blind. So that the patient is not aware of the type of measures that will be performed for him, but since the measurement of parameters is done by the researcher, the researcher does not blind. N/A Condition 1: Hypothermia of newborn. Condition 2: Hypothermia. Intervention 1: Control group: Performing routine care in the operating room to maintain the patient's temperature and prevent hypothermia. Intervention 2: Intervention group: In this group, heated solutions up to 32 ° C are used for skin disinfection, heated solutions up to 37 ° C are used for intravenous infusion, and before transferring the patient to recovery, the recovery bed and blanket will be heated by the warmer. Yes - There is a plan to make this available What will be shared: The results of the study will be published along with the working method and executive protocols after the end of the study. Patients' personal information will be kept secure and only the results of the intervention will be available. When: Access period starts from the second half of 1401 To whom: Researchers working in academic and scientific institutions Conditions: Only the results of the study will be available for other researchers to cite. Where to obtain: Author responsible for the scientific study How to obtain: Contact the responsible author via email. Comments:
public Fatemeh Pouladkhay
Department of Operating Room, School of Paramedical Sciences, Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 pouladkhay.fatemeh@gmail.com Gonabad University of Medical Sciences scientific Fatemeh Pouladkhay
Department of Operating Room, School of Paramedical Sciences, Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi
Gonabad Iran (Islamic Republic of) 9691793718 +98 51 5722 3028 pouladkhay.fatemeh@gmail.com Gonabad University of Medical Sciences Iran (Islamic Republic of) Children undergoing surgery with a minimum time of 30 minutes Age 3 to 18 years The patients who are candidate for general anesthesia Patients with ASA class 1 and 2 Body temperature 36.5 to 37 ° C No drug addiction Reluctance to continue participating in the project 3 years 18 years Both Occurrence of any condition that affects the patient's normal course of anesthesia and surgery, such as excessive bleeding and cardiac arrest during surgery Significant decrease in blood pressure during surgery (20% decrease in blood pressure compared to before anesthesia) Temperatures above 37.5 ° C or below 36 ° C before surgery Receiving blood and blood products during surgery Take corticosteroids Receiving non-steroidal analgesics and magnesium sulfate Prohibition to control body temperature through the tympanic membrane Receiving drugs other than fentanyl during surgery P80 Hypothermia of newborn Prevention Prevention Control group: Performing routine care in the operating room to maintain the patient's temperature and prevent hypothermia Intervention group: In this group, heated solutions up to 32 ° C are used for skin disinfection, heated solutions up to 37 ° C are used for intravenous infusion, and before transferring the patient to recovery, the recovery bed and blanket will be heated by the warmer. Hypothermia. Timepoint: The measurement of the variable in eight shifts will include the following: 5 minutes before the start of anesthesia, 5 minutes after induction of anesthesia and one minute before the start of surgery, 30 minutes after the start of surgery, after the end of surgery, at the beginning of recovery, 30 minutes and 1 hour after transferring the patient to recovery will be monitored. Method of measurement: Tympan thermometer. Hemodynamic status. Timepoint: The measurement of the variable in eight shifts will include the following: 5 minutes before the start of anesthesia, 5 minutes after induction of anesthesia and one minute before the start of surgery, 30 minutes after the start of surgery, after the end of surgery, at the beginning of recovery, 30 minutes and 1 hour after transferring the patient to recovery will be monitored. Method of measurement: Anesthesia monitor. Shivering. Timepoint: The measurement of the variable at the beginning of recovery, 30 minutes and 1 hour after transferring the patient to recovery will be monitored. Method of measurement: Mahajan and Crossley criteria will be used to evaluate the incidence of postoperative shivering. The number zero indicates the patient without shivering, the number 1 = mild shivering (hair straightening), the number 2 = moderate shivering (muscle tremors visible in one group of muscles), the number 3 = severe shivering) muscle tremors in more than one group of Muscles but not in the whole body (generalized) and the number 4 - will show very strong vibration (generalized body vibration). Recovery time. Timepoint: From the moment of arrival until the patient is discharged from recovery. Method of measurement: Timer. Gonabad University of Medical Sciences Approved 2022-01-24 Ethics Committee of Gonabad University of Medical Sciences Operating Room Department, School of Paramedical Sciences, Gonabad University of Medical Sciences, Asian Roadside, Gonabad Gonabad Razavi Khorasan Iran (Islamic Republic of)