Gagging During Transesophageal Echocardiography
Conditions
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.
Interventions
PROCEDUREAcupuncture
Needling of P6 and CV24 points
PROCEDUREPlacebo
Application of placebo acupuncture needles to the areas, where the acupoints are situated
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gagging during probe insertion | 10 minutes after TEE probe insertion | Incidence of gagging during TEE probe insertion: yes=1; no=2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Contacts
STUDY_CHAIRTaras Usichenko
University Medicine of Greifswald
Outcome results
None listed