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AcuGag: Acupuncture for Relief of Gag Reflex

Sponsor
University Medicine Greifswald (Other)
Overall Status
Recruiting
CT.gov ID
NCT03821428
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
28.2
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Acupuncture
  • Procedure: Placebo
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 13, 2019
Anticipated Primary Completion Date :
May 20, 2021
Anticipated Study Completion Date :
May 20, 2021

Arms and Interventions

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Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of gagging during probe insertion [10 minutes after TEE probe insertion]

      Incidence of gagging during TEE probe insertion: yes=1; no=2

    Secondary Outcome Measures

    1. Gagging score [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 [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

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Medicine of Greifswald Greifswald Germany 17475

    Sponsors and Collaborators

    • University Medicine Greifswald

    Investigators

    • Study Chair: Taras Usichenko, University Medicine of Greifswald

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medicine Greifswald
    ClinicalTrials.gov Identifier:
    NCT03821428
    Other Study ID Numbers:
    • BB 166/18
    First Posted:
    Jan 29, 2019
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gagging

    Study Results

    No Results Posted as of Jan 11, 2021