Acupuncture for Relief of Gag Reflex (AcuGag)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03821428 |
Recruitment Status :
Recruiting
First Posted : January 29, 2019
Last Update Posted : January 11, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gagging During Transesophageal Echocardiography | Procedure: Acupuncture Procedure: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Acupuncture for Relief of Gag Reflex in Patients Undergoing Transesophageal Echocardiography - a Randomized Placebo-controlled Trial |
Actual Study Start Date : | January 13, 2019 |
Estimated Primary Completion Date : | May 20, 2021 |
Estimated Study Completion Date : | May 20, 2021 |
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Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure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 Name: 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 Name: Placebo acupuncture |
- Incidence of gagging during probe insertion [ Time Frame: 10 minutes after TEE probe insertion ]Incidence of gagging during TEE probe insertion: yes=1; no=2
- Gagging score [ Time Frame: 10 minutes after TEE probe insertion ]Gagging score on Verbal Rating Scale from 0 to 10, where 0=no discomfort from TEE probe; 10=maximal discomfort during TEE probe insertion
- Rescue medication [ Time Frame: 10 minutes after TEE probe insertion ]Use of midazolam as rescue medication, given as a summary dose of required midazolam from minimum 1 milligram to maximum 10 milligram

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821428
Contact: Taras Usichenko, MD, PhD | +49 3834865893 | taras@uni-greifswald.de | |
Contact: Irina Müller-Kozarez, MD | +49 38348680699 | irina.mueller-kozarez@uni-greifswald.de |
Germany | |
University Medicine of Greifswald | Recruiting |
Greifswald, Germany, 17475 | |
Contact: Irina Müller-Kozarez, MD, PhD +4938348680699 irina.mueller-kozarez@uni-greifswald.de |
Study Chair: | Taras Usichenko | University Medicine of Greifswald |
Responsible Party: | University Medicine Greifswald |
ClinicalTrials.gov Identifier: | NCT03821428 |
Other Study ID Numbers: |
BB 166/18 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | January 11, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gagging Signs and Symptoms, Digestive |