Skip to main content
OpenTrials
Completed

NCT Number: NCT02690389

Electro-acupuncture and Flumazenil's Effect on Sedation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acupuncture General Anaesthesia Sedation

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Cancer Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flumazenil

Drug

used alone or with acupuncture

Acupuncture

Procedure

used alone or with flumazenil

Primary outcomes

  1. depth of general anaesthesia

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Dr. Yin Liu

Other

Collaborators

  • Sichuan Cancer Hospital and Research Institute

Registry information

Official study 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

Acronym: EA&FLUM

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2016
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.