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Acupuncture for Relief of Gag Reflex (AcuGag)

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ClinicalTrials.gov Identifier: NCT03821428
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Gagging During Transesophageal Echocardiography Procedure: Acupuncture Procedure: Placebo Not Applicable

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
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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 : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Taras Usichenko, MD, PhD +49 3834865893 taras@uni-greifswald.de
Contact: Irina Müller-Kozarez, MD +49 38348680699 irina.mueller-kozarez@uni-greifswald.de

Locations
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Germany
University Medicine of Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Irina Müller-Kozarez, MD, PhD    +4938348680699    irina.mueller-kozarez@uni-greifswald.de   
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Study Chair: Taras Usichenko University Medicine of Greifswald
More Information
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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: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gagging
Signs and Symptoms, Digestive
Signs and Symptoms