Acupuncture Mechanism in Relief of Gag Reflex
ConditionGag (Pharyngeal) Reflex
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorUniversity Medicine Greifswald
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy volunteers aged between 20-40 years old with an American Society of Anesthesiologists physical status of I to II naïve to acupuncture
Participants without previous opioid and psychotropic medication
Without use of recreational drugs 3 days prior to study sessions
Without systemic disease or local skin lesions at the sites of acupuncture
Disqualifiers
Local skin infection at the sites of acupuncture
Aged < 20 or > 35 years
History of drug allergy to local anesthetics
Participants who are unable to understand the consent form or to use numeric rating scale NRS-11
Trial design
Design model
Crossover
Treatments tested in this trial
Acupuncture
Other interventionNeedling of acupoints CV24, PC6 and K3
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: CV24Experimental treatment 1 intervention
Group B: PC6Active comparator 1 intervention
Group C: K3Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length of saliva injector insertion (cm)
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
Time frame
Day 1 ( before and after acupuncture)Secondary outcomes
1
Severity of gagging, measured using the Numeric Rating Scale NRS-11 (0=no gagging; 10=maximal)
Time frame
Day 1 ( before and after acupuncture)Sponsors and contacts
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Source ClinicalTrials.gov