AcupunctureEA&FLUMNCT02690389
Electro-acupuncture and Flumazenil's Effect on Sedation
A study testing Flumazenil and Acupuncture in people with Acupuncture and General Anaesthesia, run by Dr. Yin Liu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Acupuncture, General Anaesthesia, Sedation
- What is being tested?
- Flumazenil and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Flumazenil, Acupuncture
- Keywords
- Acupuncture, Flumazenil, Narcotrend, General Anaesthesia, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlumazenilDrug
used alone or with acupuncture
AcupunctureProcedure or surgery
used alone or with flumazenil
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | standard procedure is used |
| Flumazenil only group | Sham comparator | flumazenil is given Receives: Drug: Flumazenil |
| control with acupuncture | Active comparator | control with acupuncture Receives: Procedure: Acupuncture |
| control with acupuncture and flumazenil | Active comparator | control with acupuncture and flumazenil Receives: Drug: Flumazenil; Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
depth of general anaesthesia
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Yin Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute
- Responsible party
- Sponsor-investigator, Dr. Yin Liu, Sichuan Cancer Hospital and Research Institute
- Investigators
- yin liu, PhD, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690389
- Sponsor's protocol ID
- SiChuanCHRI001
- Acronym
- EA&FLUM
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will not be share until it is published
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02690389
- Acronym / sponsor ID
- EA&FLUM / SiChuanCHRI001
- Conditions
- Acupuncture, General Anaesthesia, Sedation
- Keywords
- Acupuncture, Flumazenil, Narcotrend, General Anaesthesia, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dr. Yin LiuUniversity, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –standard procedure is used |
| Flumazenil only group | Sham comparator | Drug: Flumazenilflumazenil is given |
| control with acupuncture | Active comparator | Procedure: Acupuncturecontrol with acupuncture |
| control with acupuncture and flumazenil | Active comparator | Drug: Flumazenil, Procedure: Acupuncturecontrol with acupuncture and flumazenil |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flumazenilused alone or with acupuncture | Drug | Flumazenil only group, control with acupuncture and flumazenil |
| Acupunctureused alone or with flumazenil | Procedure or surgery | control with acupuncture, control with acupuncture and flumazenil |
Primary outcome
depth of general anaesthesia
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Individual participant dataSharing planned: No. Data will not be share until it is published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yin liu, PhD principal investigator
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flumazenil and Acupuncture in people with Acupuncture and General Anaesthesia, run by Dr. Yin Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depth of general anaesthesia (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.