Auricular acupuncture for post-operative nausea and vomiting.

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2018
INTERVENTION: 80 female adult, between 18 and 70 years old, with Body Mass Index under 35, who belong to classification 1 and 2 of the American Society of Anesthesiology will be included, 40 patients by group. The patients of both groups who fit the criteria will be instructed with the use of the analogic visual scale used to measure nausea intensity. Both groups will undergo sedation with 5‐mg midazolam intravenous 30 minutes before the surgery and will be monitored through arterial oxygen saturation. After the establishment of sedation, 0.25 x 30 mm systemic needles will be placed only on patients of the AA group for 20 minutes. After 20 minutes, the needles will be removed. The anesthesiologist, patient, and surgeon will be unaware of the study group in which the patient belongs. To ensure the placebo effect and the double blindness of the study, all (both goups) patients will taped at certain auricular sites. The auricular sites included in this study were: (1) Shen Men, located at the point of bifurcation of the superior and inferior parts of the antihelix crura and the lateral third of the triangular fossa; kidney, located at the top of the cymba and below the antihelix bifurcation; sympathetic,between the inferior branch of the antihelix and the helix; stomach, which is at the area where the root of the helix ends; occipital, located in the upper back corner of the lateral side of the antitragus. Patients of control group will not be treated No treatment). Anesthesia will be induced and maintained in both goups with 2 mg/kg of propofol intravenous, 5 mcg/kg of fentanyl intravenous, 0.6 mg/kg of the nondepolarizing muscle blocker rocuronium intravenous, 2 g cefazolin intravenous, 2 g dipyrone intravenous, 40 mg parecoxib intravenous, 10 mg metoclopramide intravenous, and continuous inhalation of sevoflurane. At the end of the surgery, atropine IV and prostigmine IV were applied for reversal of neuromuscular blockage. During surgery, blood pressure, E02.190.044.133 Procedure/surgery CONDITION: C23.550.767.859 E04.210.120.172.140 K00‐K93 M01.975 Nausea and vomiting, post operative period, laparoscopic Cholecystectomy, women ; R11 ; C23.550.767.859 ; E04.210.120.172.140 ; M01.975 PRIMARY OUTCOME: Expected outcome 1. Reduction in the number of vomiting episodes in the first six postoperative hours in the intervention group (AA), verifying through direct observation compared to the control group, with a significance of 5%. ; Events will be registered immediately after postanesthesia care unit admission and at the second, fourth, and sixth hours after the surgery. Expected outcome 2. Decreased intensity of nausea in the intervention group (AA) in relation to the control group, verified by visual analogue scale every two hours in the first six postoperative hours, with a significance of 5%. Events will be registered immediately after postanesthesia care unit admission and at the second, fourth, and sixth hours after the surgery. SECONDARY OUTCOME: Expected outcome 3. Decreased demand for use of antiemetic drugs in the first six postoperative hours, verified by the direct observation of the researcher, upon spontaneous request of the patient. It is expected a decreased demand for drugs in the intervention group (AA) with a significance level of 5%. Events will be registered immediately after postanesthesia care unit admission and at the second, fourth, and sixth hours after the surgery. ; INCLUSION CRITERIA: adult females between; 18 and 70 years old; with Body Mass Index under 35; who belong to classification 1 and 2 of the American Society of Anaesthesiology; submitted to uncomplicated Laparoscopic cholecystectomy.
Epistemonikos ID: 399905cce5e2999e5041392d86ba00908e5ae012
First added on: Aug 24, 2024