Electro-acupuncture and Flumazenil's Effect on Sedation

NCT ID: NCT02690389

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

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 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.

Detailed Description

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Conditions

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Acupuncture General Anaesthesia Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

standard procedure is used

Group Type NO_INTERVENTION

No interventions assigned to this group

Flumazenil only group

flumazenil is given

Group Type SHAM_COMPARATOR

Flumazenil

Intervention Type DRUG

used alone or with acupuncture

control with acupuncture

control with acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

used alone or with flumazenil

control with acupuncture and flumazenil

control with acupuncture and flumazenil

Group Type ACTIVE_COMPARATOR

Flumazenil

Intervention Type DRUG

used alone or with acupuncture

Acupuncture

Intervention Type PROCEDURE

used alone or with flumazenil

Interventions

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Flumazenil

used alone or with acupuncture

Intervention Type DRUG

Acupuncture

used alone or with flumazenil

Intervention Type PROCEDURE

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role collaborator

Dr. Yin Liu

OTHER

Sponsor Role lead

Responsible Party

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Dr. Yin Liu

Associate Professor, Chief of Clinical Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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yin liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Sichuan University

Locations

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Sichuan Cancer Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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SiChuanCHRI001

Identifier Type: -

Identifier Source: org_study_id

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