Background:
Gagging during transesophageal echocardiography examination (TEE) can be distressing and even dangerous for patients. The
needling of
acupuncture point CV24 was described to be effective in reducing the gag reflex during TEE in patients with
ischemic stroke or
transient ischemic attack. Methods: 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 placebo needles at the same areas. Patients, the practitioners who will perform the TEE procedure, and the assessor of the outcome measures will be unaware of the group's (real or placebo) allocation. Results: 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 TEE procedure, success of patients' blinding (patients' opinion to group allocation), heart rate and oxygen saturation measured by pulse oxymetry. Conclusions: To study the effects of acupuncture against
gagging during TEE, we test the
needling of
acupoints CV24 and
PC6 bilaterally. A placebo acupuncture is used for the control group. Trial registration number: NCT NCT0382142.