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IRCT20120910010800N10 IRCT 2023-01-15 Shahid Beheshti University of Medical Sciences Comparison of crystalloid with colloid in sensory level induced by spinal anesthesia in cesarean section A randomized study to compare the sensory levels of spinal anesthesia for elective cesarean section using crystalloid versus Voluven solution 2023-02-04 anticipated 120 Complete https://irct.ir/trial/67216 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by permutation blocks using PASS ver 21.0.3 software. This software will obtain a list of random numbers, and each number will be assigned to one of the study groups. The assigned numbers will be written on the card, and each card will be placed in an opaque envelope, sealed, and kept in a drawer. When admitting the patient to the operating room, an anesthesia technician who will not interfere in the next stages of the plan, will randomly pick a card for each patient, and based on that, the patient will be placed in one of the three groups of normal saline, Ringer's or tetrastarch, Blinding description: During the admission, the anesthesia technician will determine the patient's group using the numbers of the pre-prepared cards. An anesthesiologist who will not be involved in the later stages of the plan will supervise fluid administration by the group. No one except the technician will be aware of the patient's group until the questionnaire information is completed and the patient leaves the operating room. The anesthesiologist in charge of the patient, the surgeon, and the patient themselves will not be aware of the study group. 3 Hypotension due to drugs. Intervention 1: Intervention group: Normal saline group: Within thirty minutes before spinal anesthesia, the anesthesiologist will inject 10 ml/kg of 0.9% sodium chloride solution intravenously to the patient. Intervention 2: Intervention group: Ringer's group: Within thirty minutes before spinal anesthesia, the anesthesiologist will inject 10 ml/kg of Ringer's solution to the patient intravenously. Intervention 3: Intervention group: Voluven group: Within thirty minutes before spinal anesthesia, the anesthesiologist will inject 5 ml/kg of Voluven solution to the patient intravenously. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: One year after the publication of the article To whom: All jobs Conditions: All non-personal patient information (anonymously) can be accessed by contacting the responsible author. Where to obtain: email to: drdariushabtahi@yahoo.com How to obtain: Sending email and review by the responsible author. Comments:
public Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dariush Abtahi
Emam Hossein Hospital, Shahid Madani St
Tehran Iran (Islamic Republic of) 1617763141 +98 21 2263 2611 d.abtahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) singleton pregnancy Elective cesarean section Gestational age more than 36 weeks Height more than 150 and less than 175 cm Body mass index less than 35 kg/m2 Consent to study 18 years no limit Female Sensitivity to local anesthetics I95.2 Hypotension due to drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Normal saline group: Within thirty minutes before spinal anesthesia, the anesthesiologist will inject 10 ml/kg of 0.9% sodium chloride solution intravenously to the patient. Intervention group: Ringer's group: Within thirty minutes before spinal anesthesia, the anesthesiologist will inject 10 ml/kg of Ringer's solution to the patient intravenously. Intervention group: Voluven group: Within thirty minutes before spinal anesthesia, the anesthesiologist will inject 5 ml/kg of Voluven solution to the patient intravenously. The sensory level obtained after spinal anesthesia. Timepoint: Every 5 to 30 minutes after spinal anesthesia and then at 60 and 90 minutes. Method of measurement: The sensory level will be assessed along the midline of the abdomen from T12 towards the patient's head with a blunt needle. Hypotension after spinal anesthesia. Timepoint: Throughout the operation in 5-minute intervals to 30 minutes, then in 10-minute intervals until the end of the operation. Method of measurement: Standard blood pressure monitoring. Shahid Beheshti University of Medical Sciences Approved 2023-01-01 Research Ethics Committees of Shahid Beheshti University of Medical Science Emam Hossein Hospital, Shahid Madani St. Tehran Tehran Iran (Islamic Republic of)