Electro-acupuncture and Flumazenil's Effect on Sedation
NCT ID: NCT02690389
Last Updated: 2016-02-24
Study Results
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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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-01-31
2015-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Control
standard procedure is used
No interventions assigned to this group
Flumazenil only group
flumazenil is given
Flumazenil
used alone or with acupuncture
control with acupuncture
control with acupuncture
Acupuncture
used alone or with flumazenil
control with acupuncture and flumazenil
control with acupuncture and flumazenil
Flumazenil
used alone or with acupuncture
Acupuncture
used alone or with flumazenil
Interventions
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Flumazenil
used alone or with acupuncture
Acupuncture
used alone or with flumazenil
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
60 Years
ALL
No
Sponsors
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Sichuan Cancer Hospital and Research Institute
OTHER
Dr. Yin Liu
OTHER
Responsible Party
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Dr. Yin Liu
Associate Professor, Chief of Clinical Research
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
Countries
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Other Identifiers
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SiChuanCHRI001
Identifier Type: -
Identifier Source: org_study_id
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