Acupuncture for Relief of Gag Reflex

Study Overview
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Brief Summary
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The aim of the study is to test whether stimulation of acupuncture points CV24 and P6 is better than placebo acupuncture in treatment of gagging in patients undergoing elective transesophageal echocardiography (TEE)

Detailed Description
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Patients undergoing elective transesophageal echocardiography (TEE) often report discomfort because of active gagging reflex, which sometimes preclude the performance of TEE and requires additional medication. According to existing literature, needling of acupoint CV24 effectively prevents gagging during dental procedures. We are going to use this phenomenon in patients scheduled to TEE in order to reduce discomfort during insertion of TEE probe and reduce the need for additional sedative medication. Within this investigation the patients will be randomly assigned to receive either verum acupuncture of CV24 and P6 acupoints or placebo procedure immediately before TEE examination. As outcome the incidence and intensity of gagging, total dose of additional sedative medication and hemodynamic parameters will be recorded.

Official Title
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Acupuncture for Relief of Gag Reflex in Patients Undergoing Transesophageal Echocardiography - a Randomized Placebo-controlled Trial

Conditions
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Gagging During Transesophageal Echocardiography

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective ambulatory transesophageal echocardiography (TEE) without sedation TEE time does not exceed 30 minutes Patients without previous opioid and psychotropic medication Patients aged between 30 and 65 years, able to use visual analogue scale 100 mm Patients who have given written informed consent Exclusion Criteria: Current psychiatric disease Local skin infection at the sites of acupuncture Aged < 30 or > 65 years TEE time more than 30 min Patients who consumed opioid medication at least 6 months before surgery Patients with the history of: i) psychiatric disease; ii) insulin-dependent diabetes mellitus; iii) radio- or chemotherapy; iv) peripheral polyneuropathy. Patients who are unable to understand the consent form or to use visual analogue scale 100 mm

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure | Procedure: Acupuncture<br>* Needling of P6 and CV24 points<br>* Other names: Verum acupuncture;|
| Placebo Comparator: Control<br>Application of Placebo needles in the areas of P6 and CV24 acupoints | Procedure: Placebo<br>* Application of placebo acupuncture needles to the areas, where the acupoints are situated<br>* Other names: Placebo acupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gagging during probe insertion | Incidence of gagging during TEE probe insertion: yes=1; no=2 | 10 minutes after TEE probe insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gagging score | Gagging score on Verbal Rating Scale from 0 to 10, where 0=no discomfort from TEE probe; 10=maximal discomfort during TEE probe insertion | 10 minutes after TEE probe insertion | 
| Rescue medication | Use of midazolam as rescue medication, given as a summary dose of required midazolam from minimum 1 milligram to maximum 10 milligram | 10 minutes after TEE probe insertion |