Sedation Clinical Trial
— EA&FLUMOfficial title:
The Sedation Effect of Electro-acupuncture on Bilateral Zusanli (ST 36) and Neiguan (PC 6) in General Anesthesia May Not be Mediated by the Benzodiazepines- GABA Pathway
Verified date | February 2016 |
Source | Sichuan Cancer Hospital and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: SDA |
Study type | Interventional |
Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in
general anaesthesia through investigating the role of the Benzodiazepines-GABA system.
Method: 80 patients undergoing abdominal surgery were randomly divided into four groups
(n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group
(propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture +
flumazenil group). Before induction, acupuncture needles were inserted at the points of
Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicit"DeQi". Target-controlled infusion
(TCI) of propofol was used for the induction and maintenance of anaesthesia. After
15minutes, equilibrium of Narcotrend Index (NT index) was achieved, patients were then
assigned to receive different interventions. In EA group and EA+F group, patients received
EA for 30 minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was
added in the latter at the end of EA. In C group and F group, patients didn't receive EA,
and flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time
point with EA+F group. HR, MAP and NT index were recorded at different time points up to 30
minutes after the end of EA.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 80 abdominal surgical patients - aged 30 to 60 years old, - weighing 50-70Kg, - ASA I-?, who scheduled to receive general anaesthesia were enrolled to this trial. Exclusion Criteria: - Hypertension or severe heart and lung diseases, - Conditions that might affect the consciousness or NT index, such as seizures, psychosis, brain lesions, and treatment with sedative drugs, - Contraindications to acupuncture, such as severe hemorrhagic disease, hyper-sensitive patient, and tumor or ulcer exist on the skin of the acupuncture points. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
China | Sichuan Cancer Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Dr. Yin Liu | Sichuan Cancer Hospital and Research Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | depth of general anaesthesia | 2 hours | No |
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