Gagging During Transesophageal EchocardiographyAcuGagNCT03821428
Acupuncture for Relief of Gag Reflex
A study testing Acupuncture in people with Gagging During Transesophageal Echocardiography, run by University Medicine Greifswald at 1 site in Germany.
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) Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Gagging During Transesophageal Echocardiography
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jan 2019to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Being tested
- Acupuncture, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Verum acupuncture
Needling of P6 and CV24 points
PlaceboProcedure or surgery
Also called Placebo acupuncture
Application of placebo acupuncture needles to the areas, where the acupoints are situated
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure Receives: Procedure: Acupuncture |
| Control | Placebo comparator | Application of Placebo needles in the areas of P6 and CV24 acupoints Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gagging during probe insertion
Incidence of gagging during TEE probe insertion: yes=1; no=2
Measured: 10 minutes after TEE probe insertion
Secondary outcomes (2)
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
Measured: 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
Measured: 10 minutes after TEE probe insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start13 Jan 2019
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gagging During Transesophageal EchocardiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taras Usichenko, Study chair, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821428
- Sponsor's protocol ID
- BB 166/18
- Acronym
- AcuGag
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2019
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Usichenko TI, Muller-Kozarez I, Busch R, Knigge S, Busch M. Acupuncture for relief of gagging in patients undergoing transoesophageal echocardiography-a randomised placebo-controlled trial. Clin Res Cardiol. 2026 Nov 2. doi: 10.1007/s00392-026-03048-5. Online ahead of print.
PubMed 42970035
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Relief of Gag Reflex in Patients Undergoing Transesophageal Echocardiography - a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03821428
- Acronym / sponsor ID
- AcuGag / BB 166/18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureNeedling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure |
| Control | Placebo comparator | Procedure: PlaceboApplication of Placebo needles in the areas of P6 and CV24 acupoints |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Verum acupunctureNeedling of P6 and CV24 points | Procedure or surgery | Acupuncture |
| PlaceboAlso: Placebo acupunctureApplication of placebo acupuncture needles to the areas, where the acupoints are situated | Procedure or surgery | Control |
Primary outcome
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
2 secondary outcomes
Gagging score
Time frame: 10 minutes after TEE probe insertion
Rescue medication
Time frame: 10 minutes after TEE probe insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Derived from this study: PubMed 42970035Usichenko TI, Muller-Kozarez I, Busch R, Knigge S, Busch M. Acupuncture for relief of gagging in patients undergoing transoesophageal echocardiography-a randomised placebo-controlled trial. Clin Res Cardiol. 2026 Nov 2. doi: 10.1007/s00392-026-03048-5. Online ahead of print.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taras Usichenko study chair
University Medicine of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Gagging During Transesophageal Echocardiography, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of gagging during probe insertion (time frame: 10 minutes after TEE probe insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03821428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.