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IRCT20211009052704N1 IRCT 2021-12-04 Birjand University of Medical Sciences Evaluation of the effect of dexmedetomidine on the prevention of postoperative shivering Evaluation of the effect of dexmedetomidine on the prevention of postoperative shivering in patients undergoing eye, ear, throat and nose surgeries 2021-10-09 anticipated 100 Complete https://irct.ir/trial/59195 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients are randomly divided into two groups. Each patient will enter one of the intervention groups randomly before going to the operating room using the color cards that are placed in the envelope and the patient will choose one. For example, if a yellow card is selected, the patient will be in the group receiving dexmedetomidine and if a blue card is selected, the patient will be in the placebo group, Blinding description: The severity of shivering in patients is classified by the intern without knowing the patient group. Patients and the evaluator do not know their group and the drug received (double-blind study). 3 The effect of dexmedetomidine on the prevention of postoperative shivering in patients undergoing eye, ear, throat and nose surgeries. Intervention 1: Intervention group: The group of patients is injected with Ringer serum according to the relevant formulas before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen is performed by anesthesia mask for all patients. Fentanyl(Darou Pakhsh Pharmaceutical Co./and each vial is 50 micrograms per 10 cc) 2 kg / µg, thiopental sodium(Panpharma Co./500mg) 5 mg / kg and atracurium(Aburaihan ‌Pharmaceutical Co/50 mg per 5 ml) 0.5 mg / kg will be used to induce anesthesia in all patients. Maintenance of anesthesia in each group will be performed using propofol(Fresenius Kabi Co./200 mg per 20 ml) 50-150 µg / kg / min. Temperature All serums were the same and all were supplied from the shared serum storage room. Room temperature between 25-28 degrees and a serum was randomly selected daily to measure the temperature. Environment: Light and temperature were equal and the drugs and liquids were kept in the same rooms in terms of temperature.Monitoring: Routine including ECG, pulse oximetry, NIBP every 10 minutes and capnography were performed for all patients. In the intervention group, dexmedetomedin (1 µg / kg 1) was infused intravenously 10 minutes before extubation. (1 µg / kg diluted in 50 cc normal saline).The vials are provided by Exir Company, Boroujerd, Iran. Each vial is 200 micrograms in 2 ml. Intervention 2: Control group: patients is injected with Ringer serum according to the relevant formulas before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen is performed by anesthesia mask for all patients. Fentanyl 2 kg / µg, thiopental sodium 5 mg / kg and atracurium 0.5 mg / kg will be used to induce anesthesia in all patients. Maintenance of anesthesia in each group will be performed using propofol 50-150 µg / kg / min.Temperature All serums were the same and all were supplied from the shared serum storage room. Room temperature between 25-28 degrees and a serum was randomly selected daily to measure the temperature. Environment: Light and temperature were equal and the drugs and liquids were kept in the same rooms in terms of temperature.Monitoring: Routine including ECG, pulse oximetry, NIBP every 10 minutes and capnography were performed for all patients. In the control group, 50 cc of normal saline is infused intravenously 10 minutes before induction of extubation and within 10 minutes. Fentanyl provided by Darou Pakhsh Pharmaceutical Co. and each vial is 50 micrograms per 10 cc. thiopental sodium provided by Panpharma Co./500mg. atracurium provided by Aburaihan ‌Pharmaceutical Co. / 50 mg per 5 ml and propofol provided by Fresenius Kabi Co. 200 mg per 20 ml. Yes - There is a plan to make this available What will be shared: Data related to hemodynamic parameters of the subjects included shivering intensity, heart rate. Patients' systolic and diastolic blood pressure are measured at regular intervals will be released after the person is unidentified and the effect of the interventions is described in a general article. When: Accessibility after publishing the article To whom: Published data is accessible to all people working in different fields. Conditions: The data can be used for review and use to develop guidelines and further research on this drug. Where to obtain: After completing the study, the documents will be registered in the Pazhoohan. How to obtain: The application will be shared within two working weeks if eligible after review by the project manager. Comments:
public Bibifateme Shakhs Imampoor
Ghafari blvd
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3239 5000 shakhsemampour@bums.ac.ir Birjand University of Medical Sciences scientific Bibifateme Shakhs Imampoor
Ghafari blvd. Birjand university of medical science
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3239 5000 shakhsemampour@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Having informed consent to enter the study ASA Class 1 and 2 20 years 60 years Both Emergency surgery Patients with ASA 3 and above Drug addiction History of Malignant hyperthermia Seizures Anaphylaxis Severe cardiovascular disease Severe kidney, lung, liver disease or any Uncontrolled systemic disease History of taking anti-psychotic drugs, analgesics, narcotics, alcohol, anti-inflammatory drugs Includes both nsaid and corticosteroids Neuromuscular diseases Thyroid disease, Dysautonomy, Obesity (BMI> 30), Pregnancy Prevention Placebo Intervention group: The group of patients is injected with Ringer serum according to the relevant formulas before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen is performed by anesthesia mask for all patients. Fentanyl(Darou Pakhsh Pharmaceutical Co./and each vial is 50 micrograms per 10 cc) 2 kg / µg, thiopental sodium(Panpharma Co./500mg) 5 mg / kg and atracurium(Aburaihan ‌Pharmaceutical Co/50 mg per 5 ml) 0.5 mg / kg will be used to induce anesthesia in all patients. Maintenance of anesthesia in each group will be performed using propofol(Fresenius Kabi Co./200 mg per 20 ml) 50-150 µg / kg / min. Temperature All serums were the same and all were supplied from the shared serum storage room. Room temperature between 25-28 degrees and a serum was randomly selected daily to measure the temperature. Environment: Light and temperature were equal and the drugs and liquids were kept in the same rooms in terms of temperature.Monitoring: Routine including ECG, pulse oximetry, NIBP every 10 minutes and capnography were performed for all patients. In the intervention group, dexmedetomedin (1 µg / kg 1) was infused intravenously 10 minutes before extubation. (1 µg / kg diluted in 50 cc normal saline).The vials are provided by Exir Company, Boroujerd, Iran. Each vial is 200 micrograms in 2 ml Control group: patients is injected with Ringer serum according to the relevant formulas before induction of anesthesia. Pre-oxygenation with 5 Lit / min oxygen is performed by anesthesia mask for all patients. Fentanyl 2 kg / µg, thiopental sodium 5 mg / kg and atracurium 0.5 mg / kg will be used to induce anesthesia in all patients. Maintenance of anesthesia in each group will be performed using propofol 50-150 µg / kg / min.Temperature All serums were the same and all were supplied from the shared serum storage room. Room temperature between 25-28 degrees and a serum was randomly selected daily to measure the temperature. Environment: Light and temperature were equal and the drugs and liquids were kept in the same rooms in terms of temperature.Monitoring: Routine including ECG, pulse oximetry, NIBP every 10 minutes and capnography were performed for all patients. In the control group, 50 cc of normal saline is infused intravenously 10 minutes before induction of extubation and within 10 minutes. Fentanyl provided by Darou Pakhsh Pharmaceutical Co. and each vial is 50 micrograms per 10 cc. thiopental sodium provided by Panpharma Co./500mg. atracurium provided by Aburaihan ‌Pharmaceutical Co. / 50 mg per 5 ml and propofol provided by Fresenius Kabi Co. 200 mg per 20 ml. Classification of shivering. Timepoint: Classification of shivering immediately after recovery, 10, 20, 30, 40, 50, 60 minutes after surgery. Method of measurement: Zero = lack of muscle tremor / 1 = hair straightening, peripheral cyanosis / 2 = muscle tremor visible in one muscle group / 3 = muscle tremor visible in more than one muscle group / 4 = muscle tremor visible in all muscles of the body by The ward intern will be evaluated without informing the patient group. Comparison of mean systolic and diastolic blood pressure. Timepoint: Comparison of mean systolic and diastolic blood pressure immediately after recovery, 10, 20, 30, 40, 50, 60 minutes after surgery. Method of measurement: Patients' blood pressure is measured with a sphygmomanometer cuff at regular intervals and recorded in prepared tables. Comparison of mean pulse beats. Timepoint: Comparison of mean pulse beats immediately after recovery, 10, 20, 30, 40, 50, 60 minutes after surgery. Method of measurement: Patients' pulse is counted in one minute. Birjand University of Medical Sciences Approved 2021-10-09 Ethics committee of Birjand University of Medical Sciences Ghafari blvd,Birjand town Birjand South Khorasan Iran (Islamic Republic of)