Comparison of the Effectiveness of Ginger with Ondansetron on Nausea and Vomiting after Cesarean Section under Spinal Anesthesia with Fentanyl; a Randomized clinical Trial

Comparison of the Effectiveness of Ginger with Ondansetron on Nausea and Vomiting after Cesarean Section under Spinal Anesthesia with Fentany

double-blind randomized clinical trial, phase 3 on 90 patients, web-based randomization software was used for randomization.

The present study will be performed on reducing nausea and vomiting in 90 patients aged 18-40 years who are candidates for cesarean section by spinal anesthesia in Bint Al-Huda Hospital of North Khorasan University of Medical Sciences. Patients are randomly assigned to three groups using a web-based system. Evaluation of nausea and vomiting by visual analog scale will be assessed at time intervals: recovery, 4, 8, 12 and 24 hours after surgery. To perform blinding, patients, surgeons, and individuals performing assessment work at different intervals will be blinded to the groups.

Inclusion criteria: Patients must be vigilant. Do not be the Absolute contraindications for spinal anesthesia. Do not have heart disease. Has not taken anti-nausea or corticosteroids in the 24 hours before surgery. Exclusion criteria: Do not be allergic to the drugs in the study.

In the first group, patients receive two ginger capsules (each capsule containing one gram of ginger) orally. In the second group, patients receive two ondansetron tablets (each containing 4 mg of ondansetron). (Due to the blindness of the study, ondansetron tablets are placed inside the capsule cover in the same shape as other interventions) In the third group, patients receive two placebo capsules.

Intensity of nausea and Incidence of vomiting

Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 6. So that in each block, there are 2 people in the first group (A), two people in the second group (B) and two people in the third group (C). After a random sequence was identified in all blocks, cards were written by writing C, B, and A to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 90 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group.

None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Also in all three groups; Patients receive the same intervention (receiving two capsules of the same shape one hour before the operation). Therefore, the study is double-blind so that patients and the outcome assessment specialist are unaware of the status of the three groups assigned to the study.

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