Electro-acupuncture and Flumazenil's Effect on Sedation

Sedation Clinical Trial

— EA&FLUM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690389
• Other study ID #: SiChuanCHRI001
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: February 18, 2016
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: SDA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• 80 abdominal surgical patients

• aged 30 to 60 years old,

• weighing 50-70Kg,

• ASA I-?, 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acupuncture
• General Anaesthesia
• Sedation

Intervention

Drug:
• Flumazenil
used alone or with acupuncture

Procedure:
• Acupuncture
used alone or with flumazenil

Locations

Country	Name	City	State
China	Sichuan Cancer Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Yin Liu	Sichuan Cancer Hospital and Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depth of general anaesthesia		2 hours	No