Electro-acupuncture and Flumazenil's Effect on Sedation

NCT02690389 | Completed DMC

• 1 other identifier: SiChuanCHRI001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acupuncture; General Anaesthesia; Sedation

Keywords

Acupuncture; Flumazenil; Narcotrend; General Anaesthesia; Sedation

Outcome Measures

Primary Outcomes (1)

• depth of general anaesthesia

  2 hours

Study Arms (4)

Control

NO INTERVENTION

standard procedure is used

Flumazenil only group

SHAM COMPARATOR

flumazenil is given

Drug: Flumazenil

control with acupuncture

ACTIVE COMPARATOR

control with acupuncture

Procedure: Acupuncture

control with acupuncture and flumazenil

ACTIVE COMPARATOR

control with acupuncture and flumazenil

Drug: Flumazenil; Procedure: Acupuncture

Interventions

Flumazenil DRUG

used alone or with acupuncture

Flumazenil only group; control with acupuncture and flumazenil

Acupuncture PROCEDURE

used alone or with flumazenil

control with acupuncture; control with acupuncture and flumazenil

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Yin Liu: lead
• Sichuan Cancer Hospital and Research Institute: collaborator

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Interventions

Flumazenil; Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Complementary Therapies; Therapeutics

Study Officials

• yin liu, PhD

  Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Chief of Clinical Research

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 24, 2016
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)