Electro-acupuncture and Flumazenil's Effect on Sedation

Study Overview
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Brief Summary
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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 elicitDeQi. 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.

Official Title
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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

Conditions
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Acupuncture, General Anaesthesia, Sedation

Intervention / Treatment
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* Drug: Flumazenil
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 80 abdominal surgical patients aged 30 to 60 years old, weighing 50-70Kg, ASA I-Ⅱ, 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>standard procedure is used | |
| Sham Comparator: Flumazenil only group<br>flumazenil is given | Drug: Flumazenil<br>* used alone or with acupuncture<br>|
| Active Comparator: control with acupuncture<br>control with acupuncture | Procedure: Acupuncture<br>* used alone or with flumazenil<br>|
| Active Comparator: control with acupuncture and flumazenil<br>control with acupuncture and flumazenil | Drug: Flumazenil<br>* used alone or with acupuncture<br>Procedure: Acupuncture<br>* used alone or with flumazenil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth of general anaesthesia |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Flumazenil, Narcotrend, General Anaesthesia, Sedation