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

Sponsor

Dr. Yin Liu (Other)

Overall Status

Completed

CT.gov ID

NCT02690389

Collaborator

Sichuan Cancer Hospital and Research Institute (Other)

Enrollment

Location

Arms

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acupuncture General Anaesthesia Sedation	Drug: Flumazenil Procedure: Acupuncture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official 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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control standard procedure is used
Sham Comparator: Flumazenil only group flumazenil is given	Drug: Flumazenil used alone or with acupuncture
Active Comparator: control with acupuncture control with acupuncture	Procedure: Acupuncture used alone or with flumazenil
Active Comparator: control with acupuncture and flumazenil control with acupuncture and flumazenil	Drug: Flumazenil used alone or with acupuncture Procedure: Acupuncture used alone or with flumazenil

Outcome Measures

Primary Outcome Measures

depth of general anaesthesia [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.