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IRCT20210626051714N1 IRCT 2021-07-16 Zanjan University of Medical Sciences A comparison of sedation with thiopental–fentanyl versus propofol–fentanyl for anterior shoulder dislocation reduction in Emergency department A comparison of sedation with thiopental–fentanyl versus propofol–fentanyl for anterior shoulder dislocation reduction in Emergency department 2019-09-23 anticipated 100 Complete https://irct.ir/trial/57179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples were selected from 100 patients with anterior shoulder dislocation who referred to the trauma emergency department of Ayatollah Mousavi Hospital, Zanjan University of Medical Sciences. Samples were randomly divided into 50 subjects in the thiopental-fentanyl group and 50 subjects in the propofol-fentanyl group using a random number table. Sampling was continued until the number of samples in each group was completed, Blinding description: This study was performed as a double-blind study. In this study, after obtaining informed consent, patients were randomly divided into two groups using a table of random numbers. In this study, two types of pocket were used. pocket A contained propofol and fentanyl and envelope B contained thiopental and fentanyl. According to the patient group, the pocket related to that patient was delivered to the nurse for drug injection. The drug was injected in the presence of the researcher by a nurse who injected the type of drug and knew its side effects, but the researcher was not aware of the type of drug. It should be noted that patients did not know the type of sedative injectable. 2 Anterior Shoulder Dislocations. Intervention 1: Intervention group: In group A patients, propofol - 0.5 mg / kg fentanyl µg/kg was used as intervention group A. Intervention 2: Intervention group: In group B, thiopental was used titrated to 1 mg / kg - fentanyl 1 µg/kg. Yes - There is a plan to make this available What will be shared: After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary). When: The start of the access period to the data of this study will be from Early 2022 and approximately 6 months after the publication of the results. To whom: The data from this study will be available to all people who can play a role in caring for Anterior Shoulder Dislocations patients, such as families, and healthcare workers. Conditions: The researcher tend to use data to improve patients, especially Anterior Shoulder Dislocations patients. Where to obtain: To receive information anyone can be use the following email:ngarjani@zums.ac.ir How to obtain: The data will be sended to the applicants after her introduction and the reason for the need for data. Comments:
public Dr. Nayereh Garjani
Ayatollah Mousavi Hospital, Gavazang Street,Pro. Soboti Blv, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4513956183 009833130000 ngarjani@zums.ac.ir Zanjan University of Medical Sciences scientific Dr. Nayereh Garjani
Ayatollah Mousavi hospital, Gavazang Street, Pro. Soboti Blv, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 ngarjani@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study People 18 to 40 years old with anterior shoulder dislocation 18 years 40 years Both Patients with fractures and major dislocations Other major injuries with hemodynamic disturbances History of substance abuse Patients with allergies to any of the drugs Pregnancy S43.016A Anterior dislocation of unspecified humerus, initial encounter Treatment - Drugs Treatment - Drugs Intervention group: In group A patients, propofol - 0.5 mg / kg fentanyl µg/kg was used as intervention group A. Intervention group: In group B, thiopental was used titrated to 1 mg / kg - fentanyl 1 µg/kg. Duration of sedation in three stages 1- Start of sedation 2- Between sedation and awakening 3- Between awakening to full consciousness. Timepoint: 1- Start of sedation 2- Between sedation and awakening 3- Between awakening to full consciousness. Method of measurement: Using a stopwatch. Zanjan University of Medical Sciences Approved 2019-08-27 Ethics Committee of Deputy of Research and Technology of Zanjan University of Medical Sciences Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran Zanjan Zanjan Iran (Islamic Republic of)