Gag (Pharyngeal) Reflex
Conditions
Brief summary
The gag reflex relief effect of acupuncture of CV24 acupoint will be compared to acupuncture of PC6 and K3 acupoints in healthy volunteers in crossover mode. Second step will be the investigation whether local anesthesia using EMLA creme will block the gag relief effect of CV24 acupuncture in healthy volunteers.
Interventions
OTHERAcupuncture
Needling of acupoints CV24, PC6 and K3
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers aged between 20-40 years old with an American Society of Anesthesiologists physical status of I to II naïve to acupuncture 2. Participants without previous opioid and psychotropic medication 3. Without use of recreational drugs 3 days prior to study sessions 4. Without systemic disease or local skin lesions at the sites of acupuncture 5. Without drug allergy to local anesthetics, especially EMLA preparation 6. Participants who have given written informed consent
Exclusion criteria
1. Local skin infection at the sites of acupuncture 2. Aged \< 20 or \> 35 years 3. History of drug allergy to local anesthetics 4. Participants who are unable to understand the consent form or to use numeric rating scale NRS-11 Discontinuation Criteria 1. Any adverse effects during study session 2. In case of local or systemic infection 3. In case if subject will withdraw from participation in this study at any time, for any reason, specified or non-specified, and without penalty or loss of benefits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of saliva injector insertion (cm) | Day 1 ( before and after acupuncture) | Saliva injector is inserted intraoral slowly until the gagging (pharyngeal reflex) is elicited; the length of insertion of saliva injector will be measured in centimeters |
Secondary
| Measure | Time frame |
|---|---|
| Severity of gagging, measured using the Numeric Rating Scale NRS-11 (0=no gagging; 10=maximal) | Day 1 ( before and after acupuncture) |
Countries
Germany
Contacts
CONTACTTaras I Usichenko, Prof. Dr. med., MD, PhD
Outcome results
None listed