Abstract
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.
Highlights
The gag reflex is a part of a normal defense mechanism, intended to prevent unwanted, irritating, or toxic material or fluids from entering the trachea, pharynx or larynx
If the maximal dose of 5 mg midazolam is reached and the patient still experiences gagging, which precludes the insertion of the transesophageal echocardiography (TEE) probe, than incremental doses of 10 mg propofol as a rescue medication will be allowed until the TEE probe is inserted
Purpose, we will compare the acupuncture of CV24 and PC6 with a placebo procedure in a two-arm randomized controlled investigation, where the patients, cardiologists and outcome assessors will be blinded to group allocation
Summary
The gag reflex is a part of a normal defense mechanism, intended to prevent unwanted, irritating, or toxic material or fluids from entering the trachea, pharynx or larynx. The needling of acupuncture points CV24 and PC6 (Figure 1), is suggested as a complementary or TEE and will be asked if they would like to take part in the investigation. If they agree, they will have even alternative option for the treatment of gagging and concomitant nausea during various medical to sign their informed consent and will be randomly allocated to RA (30 patients) or PA (30 patients) procedures [6,7,8,9,10,11]. Acupuncture was superior to a sham procedure, was to apply andTreatment effectivefor in TEE reducing the gag reflex during TEE
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