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IRCT20201212049688N1 IRCT 2021-05-18 Kermanshah University of Medical Sciences Evaluation of the effectiveness of dexmedetomidine with sufentanil in combination with intrathecal ropivacaine on analgesia in cesarean section Comparative study of the effectiveness of dexmedetomidine with sufentanil in adding intrathecal ropivacaine on analgesia in the elective cesarean section - A Randomized Double-Blind Clinical Trial 2021-04-19 anticipated 136 Complete https://irct.ir/trial/53060 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomization of patients between the first intervention group (dexmedetomidine with ropivacaine ) and the second intervention group(sufentanil with ropivacaine) is done using random allocation software. In this software, the total sample size and number of nodes are entered into the software. The output of Shalam software is a list that randomly distributes patients in groups 1 and 2. Patients are divided into two groups according to the time of referral according to the list of the mentioned group until the end of sampling, Blinding description: The person in charge of injecting drugs is not aware of the allocation of individuals to groups. The person evaluating the patients is also unaware of the allocation. 1-2 Cesarean section. Intervention 1: Intervention group: In the first intervention group, 5 micrograms of dexmedetomidine and 12.5 micrograms of isobaric ropivacaine 0.5% are injected intrathecally into the subarachnoid space. Intervention 2: Intervention group: In the second intervention group, 5 micrograms of sufentanil with 12.5 micrograms of isobaric ropivacaine 0.5% isobars are injected intrathecally into the subarachnoid space. Yes - There is a plan to make this available What will be shared: Data on demographic information and the onset and duration of analgesia in patients are shared as anonymous codes. When: Data access to 2022 is possible. To whom: Access to the data will be open to those interested in research Conditions: Giving data for scientific use is permissible without bias Where to obtain: Can be contacted by . How to obtain: About a week from the time of the first email call. Comments:
public Hanieh Azadifar
Next to the medical school, the end of Parstar Blvd, Kermanshah, Iran.
Kermanshah Iran (Islamic Republic of) 674277533 +98 83 3427 6300 hooman.rafiee@yahoo.com Kermanshah University of Medical Sciences scientific Hanieh Azadifar
Next to the medical school, the end of Parstar Blvd, Kermanshah, Iran.
Kermanshah Iran (Islamic Republic of) 674277533 +98 83 3427 6300 hooman.rafiee@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) singleton and term pregnant women 18 to 45 years. Having a body mass of 18 to 30. Patients referred for elective cesarean section, who are classified as Class I according to the American Society of Anesthesiology (A.S.A). 18 years 30 years Both Having any underlying disease History of allergy to local anesthetic Coagulation disorders, local skin infection at the site of spinal anesthesia Surgery Emergency cesarean section Cases where we have to undergo general anesthesia during surgery O75.82 Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section Treatment - Drugs Treatment - Drugs Intervention group: In the first intervention group, 5 micrograms of dexmedetomidine and 12.5 micrograms of isobaric ropivacaine 0.5% are injected intrathecally into the subarachnoid space. Intervention group: In the second intervention group, 5 micrograms of sufentanil with 12.5 micrograms of isobaric ropivacaine 0.5% isobars are injected intrathecally into the subarachnoid space. Time of onset of analgesia. Timepoint: 1,2,4,6,8,10,12,16,20,24 hours after the end of the surgery. Method of measurement: With Visual Analog Scale. Duration of analgesia. Timepoint: 1,2,4,6,8,10,12,16,20,24 hours after the end of the surgery. Method of measurement: With Visual Analog Scale. Blood pressure changes. Timepoint: In minutes 1,5,10,15,20,25,30,60 after injection. Method of measurement: By barometer and registration in the relevant forms. Nausea. Timepoint: After the intervention. Method of measurement: By asking the patient questions and observing objectively. Vomiting. Timepoint: After the intervention. Method of measurement: By asking the patient questions and observing objectively. Headache. Timepoint: After the intervention. Method of measurement: By Visual Analog Scale. Heart rate. Timepoint: In minutes 1,5,10,15,20,25,30,60 after injection. Method of measurement: By pulse oximeter. Respiratory distress. Timepoint: After the intervention. Method of measurement: By objective observation. Kermanshah University of Medical Sciences Approved 2021-02-16 Ethic Committee of Kermanshah University of Medical Science Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,Iran Kermanshah Kermanshah Iran (Islamic Republic of)