NCT03821428

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

January 25, 2019

Last Update Submit

January 8, 2021

Conditions

Gagging During Transesophageal Echocardiography

Outcome Measures

Primary Outcomes (1)

  • Incidence of gagging during probe insertion

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

    10 minutes after TEE probe insertion

Secondary Outcomes (2)

  • Gagging score

    10 minutes after TEE probe insertion

  • Rescue medication

    10 minutes after TEE probe insertion

Study Arms (2)

Acupuncture

EXPERIMENTAL

Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure

Procedure: Acupuncture

Control

PLACEBO COMPARATOR

Application of Placebo needles in the areas of P6 and CV24 acupoints

Procedure: Placebo

Interventions

AcupuncturePROCEDURE

Needling of P6 and CV24 points

Also known as: Verum acupuncture
Acupuncture
PlaceboPROCEDURE

Application of placebo acupuncture needles to the areas, where the acupoints are situated

Also known as: Placebo acupuncture
Control

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Taras Usichenko

    University Medicine of Greifswald

    STUDY CHAIR

Central Study Contacts

Taras Usichenko, MD, PhD

CONTACT

+49 3834865893taras@uni-greifswald.de

Irina Müller-Kozarez, MD

CONTACT

+49 38348680699irina.mueller-kozarez@uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

January 13, 2019

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)