Background Gagging during transesophageal echocardiography examination (TEE) can be both distressing and even dangerous for patients. Needling of acupuncture point CV24 was described to be effective in reducing of gag reflex during TEE in patients with ischemic stroke or transient ischemic attack.
Methods/Design We describe a proposal for a prospective randomized, patient, practitioner and assessor-blinded, single-center trial with two arms/groups: real acupuncture will be compared to placebo acupuncture. A total of 60 (30 per group) patients scheduled for elective TEE in order to exclude a cardiac embolic source, endocarditis or for valve failure evaluation will be recruited according to patients’ selection criteria and receive either indwelling fixed intradermal needles at acupoints CV24 and bilateral PC6 or sham acupuncture at the same sites. Patients undergoing TEE, practitioners performing TEE, and the outcome assessors will be unaware of group (real or placebo) allocation. The primary outcome is the intensity of gagging, measured using verbal rating scale (VRS-11) from 0 = no gagging to 10 = intolerable gagging. Secondary outcomes include the incidence of gagging, the use of rescue medication, patients’ satisfaction with relief of unwanted side effects during the TEE procedure, success of patients’ blinding (patients’ opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry.
Discussion To study the effects of acupuncture to reduce gagging during TEE we test needling of the acupoints CV24 and PC6 bilaterally. Placebo acupuncture is used for the control group.