Acupuncture for Relief of Gag Reflex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-13

Study Completion Date

2021-05-20

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Gagging During Transesophageal Echocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Acupuncture

Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Needling of P6 and CV24 points

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

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

Interventions

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Acupuncture

Needling of P6 and CV24 points

Intervention Type PROCEDURE

Placebo

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

Intervention Type PROCEDURE

Other Intervention Names

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Verum acupuncture Placebo acupuncture

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No