Comparison of preventive effect of acupuncture with dexamethasone and ondansetron on nausea and vomiting after cesarean section

Evaluation of the effects of acupuncture to prevent vomiting

Clinical Trial with control group, with parallel groups, double blind, randomized, phase 3 on 90 patients. A random number table was used for randomization. The first intervention group is dexamethasone. The second intervention group is ondansetron. The control group is acupuncture.

90 Patients are examined in the gynecological surgery ward of Khatam Al-Anbia Hospital in Shahroud. The desired anti-nausea drugs (ondansetron 4 mg or dexamethasone 8 mg) are provided by the anesthesiologist in two groups to the anesthesiologist, who does not know the type of drug, and the drug is injected intravenously into the patient. We want to investigate the effect of acupuncture. PC6 points on both hands are stimulated and inserted once using induction using a special needle, and then the needle is removed from the site. In this study, participants did not know the type of drug and the time of drug injection and the time of acupuncture. Intern as a lead researcher and nurses or anesthesiologist does not know the type of drug. Data collectors do not know when the drugs were injected.

Patients in Class I and II of the American Society of Anesthesiologists (ASA I-II) between the ages of 18 and 65 are included in the study, and patients with contraindications to ondansetron or dexamethasone have a history of taking drugs that interact with ondansetron or dexamethasone Or have a history of ondansetron or dexamethasone allergies, are excluded.

The anti-nausea drugs (ondansetron 4 mg or dexamethasone 8 mg) are injected into the patients in the first and second intervention groups by anesthesia technicians. In the control group, we should examine the effect of acupuncture.

Nausea and Vomiting

Random allocation in this study is done by simple randomization method. Randomization based on a single sequence of random allocations is called simple randomization. The randomization unit in this study is individual and the random number table tool is used. Random number table is a set of numbers that are generated without a specific pattern or order and in a completely random form and become a table. To use the table of random numbers, we first preset the table to read the numbers (for example, up, down, left Or right) and then we consider numbers for the three groups in question. Consider the numbers 00-29 for intervention A, the numbers 30-59 for intervention B, and the numbers ​​of 60-89 for group C. The researcher then touches one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups, thus making a random sequence. Random allocation concealment refers to the method used to execute random sequences on study participants, in a way that prior to individual allocation, group allocated is not specified. In this study, in order to hide the random allocation, the method of opaque envelopes sealed with a random sequence is used. In this method, after making a random sequence based on the sample size of the research, a number of envelopes with aluminum wrapping (in order not to clarify the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card and the card is sealed. Letters are placed in order. In order to preserve the random sequence, the numbering of the envelopes on the outer surface is done in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants to study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.

In this study, participants did not know the type of drug and the time of drug injection and the time of acupuncture. The intern, as the lead researcher, has no knowledge of the type of drug. Nurses as health personnel do not know the type of medicine. Data Collectors do not know when the drugs were injected.

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