Acupuncture for Relief of Gag Reflex (AcuGag)

University Medicine Greifswald

Status: Unknown

Conditions: Gagging During Transesophageal Echocardiography

Treatments: Procedure: Placebo; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03821428

BB 166/18

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Acupuncture

Experimental group

Description:

Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure

Treatment:

Procedure: Acupuncture

Control

Placebo Comparator group

Description:

Application of Placebo needles in the areas of P6 and CV24 acupoints

Treatment:

Procedure: Placebo