Acupuncture for Relief of Gag Reflex (AcuGag)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Gagging During Transesophageal Echocardiography
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taras Usichenko, MD, PhD; Phone Number: +49 3834865893; Email: taras@uni-greifswald.de
• Study Contact Backup: Name: Irina Müller-Kozarez, MD; Phone Number: +49 38348680699; Email: irina.mueller-kozarez@uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • Recruiting
    • University Medicine of Greifswald
    • Contact: Irina Müller-Kozarez, MD, PhD; Phone Number: +4938348680699; Email: irina.mueller-kozarez@uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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Experimental: Acupuncture; Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure	Procedure: Acupuncture; Needling of P6 and CV24 points; Other Names: Verum acupuncture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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Study Chair: Taras Usichenko, University Medicine of Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2019
• Primary Completion (Anticipated): May 20, 2021
• Study Completion (Anticipated): May 20, 2021

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Gagging
• Other Study ID Numbers: BB 166/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No