Acupuncture for Relief of Gag Reflex

Not Applicable

• Conditions: Gagging During Transesophageal Echocardiography
• Interventions: Procedure: Placebo; Procedure: Acupuncture

• Registration Number: NCT03821428
• Lead Sponsor: University Medicine Greifswald

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)

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 Timeline

• Study Start: 2019-01-13
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11
• Primary Completion: 2021-05-20
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Application of Placebo needles in the areas of P6 and CV24 acupoints
Acupuncture	Acupuncture	Needling of acupoints P6 and CV24 with indwelling permanent needles, withdrawn after TEE procedure

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

University Medicine of Greifswald; 🇩🇪 Greifswald, Germany