Electro-acupuncture and Flumazenil's Effect on Sedation (EA&FLUM)

Dr. Yin Liu

Status: Completed

Conditions: General Anaesthesia; Acupuncture; Sedation

Treatments: Drug: Flumazenil; Procedure: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02690389

SiChuanCHRI001

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Control

No Intervention group

Description:

standard procedure is used

Flumazenil only group

Sham Comparator group

Description:

flumazenil is given

Treatment:

Drug: Flumazenil

control with acupuncture

Active Comparator group

Description:

control with acupuncture

Treatment:

Procedure: Acupuncture

control with acupuncture and flumazenil

Active Comparator group

Description:

control with acupuncture and flumazenil

Treatment:

Procedure: Acupuncture

Drug: Flumazenil