A randomized study to compare the sensory levels of spinal anesthesia for elective cesarean section using crystalloid versus Voluven solution

Comparison of crystalloid with colloid in sensory level induced by spinal anesthesia in cesarean section

Clinical trial without control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. G*Power software and permutation blocks method are used for randomization. The random numbers obtained are written on the card and each card is placed inside an opaque envelope and sealed.

In the operating room of Imam Hossein (AS) hospital in Tehran, an anesthesia technician, without the knowledge of the anesthesiologist and the patient, determined the patient group by randomly selecting a card and giving one of the solutions of each group to the anesthesiologist and records this information. Another anesthesiologist administers spinal anesthesia to the patient inside the operating room. Finally, the questionnaire is delivered to the first technician.

All pregnant mothers who are candidates for elective caesarean section refer to the operating room of Imam Hossein (AS) hospital and have singleton pregnancy, gestational age more than 36 weeks, height more than 150 and less than 175 cm, body mass index less than 35 kg/m square and have given written consent to conduct the study.

Patients will be divided into three groups. In the normal saline group, within thirty minutes before the spinal anesthesia, the anesthesiologist will inject 10 ml/kg of 0.9% sodium chloride solution into the patient intravenously. In Ringer's group, the anesthesiologist will inject 10 ml/kg of Ringer's solution intravenously within thirty minutes before spinal anesthesia. In the Voluven group, within thirty minutes before spinal anesthesia, the anesthesiologist will inject 5 ml/kg of Volvone solution to the patient intravenously.

Sensory level obtained after spinal anesthesia

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.

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.

All data is potentially shareable after unidentified individuals.

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