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Trial record 11 of 39 for:    FLUMAZENIL

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

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ClinicalTrials.gov Identifier: NCT02690389
Recruitment Status : Completed
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
Sichuan Cancer Hospital and Research Institute
Information provided by (Responsible Party):
Dr. Yin Liu, Sichuan Cancer Hospital and Research Institute

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
Drug Information available for: Flumazenil

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




Primary Outcome Measures :
  1. depth of general anaesthesia [ Time Frame: 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690389


Locations
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China, Sichuan
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610000
Sponsors and Collaborators
Dr. Yin Liu
Sichuan Cancer Hospital and Research Institute
Investigators
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Principal Investigator: yin liu, PhD Sichuan University

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Responsible Party: Dr. Yin Liu, Associate Professor, Chief of Clinical Research, Sichuan Cancer Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02690389     History of Changes
Other Study ID Numbers: SiChuanCHRI001
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be share until it is published
Keywords provided by Dr. Yin Liu, Sichuan Cancer Hospital and Research Institute:
Acupuncture
Flumazenil
Narcotrend
General Anaesthesia
Sedation
Additional relevant MeSH terms:
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Flumazenil
Antidotes
Protective Agents
Physiological Effects of Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action