Acupuncture for Relief of Gag Reflex

Gagging During Transesophageal Echocardiography Clinical Trial

— AcuGag  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821428
• Other study ID #: BB 166/18
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2019
• Est. completion date: May 20, 2021

Study information

• Verified date: January 2021
• Source: University Medicine Greifswald
• Contact: Taras Usichenko, MD, PhD
• Phone: +49 3834865893
• Email: taras[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gagging
• Gagging During Transesophageal Echocardiography

Intervention

Procedure:
• Acupuncture
Needling of P6 and CV24 points
• Placebo
Application of placebo acupuncture needles to the areas, where the acupoints are situated

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of gagging during probe insertion	Incidence of gagging during TEE probe insertion: yes=1; no=2	10 minutes after TEE probe insertion
Secondary	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
Secondary	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