Acupuncture for Relief of Gag Reflex

University Medicine Greifswald60 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gagging During Transesophageal Echocardiography

Interventions

AcupuncturePROCEDURE

Needling of P6 and CV24 points

PlaceboPROCEDURE

Application of placebo acupuncture needles to the areas, where the acupoints are situated

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective ambulatory transesophageal echocardiography (TEE) without sedation 2. TEE time does not exceed 30 minutes 3. Patients without previous opioid and psychotropic medication 4. Patients aged between 30 and 65 years, able to use visual analogue scale 100 mm 5. Patients who have given written informed consent Exclusion Criteria: 1. Current psychiatric disease 2. Local skin infection at the sites of acupuncture 3. Aged \< 30 or \> 65 years 4. TEE time more than 30 min 5. Patients who consumed opioid medication at least 6 months before surgery 6. Patients with the history of: i) psychiatric disease; ii) insulin-dependent diabetes mellitus; iii) radio- or chemotherapy; iv) peripheral polyneuropathy. 7. Patients who are unable to understand the consent form or to use visual analogue scale 100 mm

Locations (1)

University Medicine of Greifswald

Greifswald, Germany

RECRUITING

Outcomes

Primary Outcomes

Incidence of gagging during probe insertion

Incidence of gagging during TEE probe insertion: yes=1; no=2

Time frame: 10 minutes after TEE probe insertion

Secondary Outcomes

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

Time frame: 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

Time frame: 10 minutes after TEE probe insertion

Central Contacts

Taras Usichenko, MD, PhD

CONTACT

+49 3834865893 taras@uni-greifswald.de

Irina Müller-Kozarez, MD

CONTACT

+49 38348680699 irina.mueller-kozarez@uni-greifswald.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.