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IRCT20210830052344N1 IRCT 2021-10-02 Islamic Azad University Preventive effects of acupuncture on nausea and vomiting after cesarean section Comparison of preventive effect of acupuncture with dexamethasone and ondansetron on nausea and vomiting after cesarean section 2021-09-15 anticipated 90 Complete https://irct.ir/trial/58425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Nausea and Vomiting after cesarean section. Intervention 1: Intervention group 1: Injectable dexamethasone 8 mg dose is given to the patient about 30 minutes before the operation or immediately after induction of anesthesia. Dexamethasone produced by CHEMIST FACTORY Company. Dexamethasone is a corticosteroid drug and has anti-nausea and anti-emetic properties. Intervention 2: Intervention group 2: Injectable ondansetron 4 mg injection is given intramuscularly or intravenously about 30 minutes before the operation or immediately after induction of anesthesia. (Ondansetron produced by CHEMIST FACTORY Company). It is a serotonergic receptor antagonist and has anti-nausea and vomiting properties. Intervention 3: Control group: Acupuncture: In patients in the control group, we evaluate the effect of acupuncture. Stimulate the PC6 points in both hands after induction of anesthesia with a special needle for one time and for 15 seconds by rotating it clockwise and then remove the needle. The company is the importer of the product (Pars Medical Equipment Company). No - There is not a plan to make this available Justification or reason for not sharing IPD is "No more information"
public Milad Johari
No. 18, The End of 11th Alley, Moallem Ave., Shahrood Town,
Shahrood Iran (Islamic Republic of) 3613634619 +98 23 3239 4536 drmiladjohari.med92@yahoo.com Islamic Azad University scientific Milad Johari
No. 18, The End of 11th Alley, Moallem Ave., Shahrood Town,
Shahrood Iran (Islamic Republic of) 3613634619 +98 23 3239 4536 drmiladjohari.med92@yahoo.com Islamic Azad University Iran (Islamic Republic of) All class I and II patients of the American Society of Anesthesiologists ( ASA I-II ) who undergo cesarean section surgery under general anesthesia They receive opioid medications during surgery 18 years 65 years Both Patients who have a contraindication to ondansetron or dexamethasone Patients who have a history of taking drugs that interact with ondansetron or dexamethasone Patients who have a history of allergies to ondansetron or dexamethasone Patients who have a mechanical cause for postoperative nausea and vomiting (such as premature obstruction or ileus) R10-R19 Symptoms and signs involving the digestive system and abdomen Prevention Prevention Prevention Intervention group 1: Injectable dexamethasone 8 mg dose is given to the patient about 30 minutes before the operation or immediately after induction of anesthesia. Dexamethasone produced by CHEMIST FACTORY Company. Dexamethasone is a corticosteroid drug and has anti-nausea and anti-emetic properties. Intervention group 2: Injectable ondansetron 4 mg injection is given intramuscularly or intravenously about 30 minutes before the operation or immediately after induction of anesthesia. (Ondansetron produced by CHEMIST FACTORY Company). It is a serotonergic receptor antagonist and has anti-nausea and vomiting properties. Control group: Acupuncture: In patients in the control group, we evaluate the effect of acupuncture. Stimulate the PC6 points in both hands after induction of anesthesia with a special needle for one time and for 15 seconds by rotating it clockwise and then remove the needle. The company is the importer of the product (Pars Medical Equipment Company). Nausea and Vomiting. Timepoint: Nausea and Vomiting before intervention and 2, 24, 48 hours after surgery. Method of measurement: Comparative Questionnaire. Welfare Fund of Shahrood Azad University Medical School Approved 2021-09-05 Ethics Committee of Islamic Azad University- Shahrood Branch No. 17, Adjacent to the Passenger Terminal, Tehran Ave, Shahroud Town, Shahroud Semnan Iran (Islamic Republic of)