AnesthesiaTOPNCT02314650
TEAS to Reduce Propofol Consumption During General Anesthesia
A study testing acupoint stimulation, non-acupoint stimulation and electrodes attached in people with Anesthesia, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- acupoint stimulation, non-acupoint stimulation and electrodes attached
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2015to 29 Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia
- Patients with written informed consent
Who cannot join
- Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease
- Patients with drug abuse
- Patients with disease of central nervous system
- Patients with renal or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Propofol Consumption During General Anesthesia
The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.
- Conditions
- Anesthesia
- Being tested
- acupoint stimulation, non-acupoint stimulation, electrodes attached
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupoint stimulationOther
stimulation was given at acupoints
non-acupoint stimulationOther
stimulation was given at non-acupoints
electrodes attachedOther
electrode were attached to skin
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous acupoint stimulation | Experimental | Electrical stimulation was given through electrodes attached to skin at Ximen and Shenmen acupoint during anesthesia Receives: Other: acupoint stimulation; Other: electrodes attached |
| Non-acupoint stimulation | Placebo comparator | Electrical stimulation was given through electrodes attached to skin at shoulder (non-acupoint) during anesthesia Receives: Other: non-acupoint stimulation; Other: electrodes attached |
| Control | Sham comparator | patients were with electrodes attached but no stimulation was given Receives: Other: electrodes attached |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol consumption
Measured: from induction to the end of surgery,at an average of 1 hour
Secondary outcomes (5)
time to awake
Measured: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
time to extubation
Measured: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
effect site concentration of propofol at awake
Measured: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
highest sedation score during stay at postanesthesia care unit
Measured: from end of surgery to discharge from post anesthesia care unit, at an average of 1 hour
nausea and vomiting during stay at postanesthesia care unit
Measured: 30min after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study start25 Aug 2015
- Primary completion28 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Zhihong LU, PhD, Principal investigator, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314650
- Sponsor's protocol ID
- XJH-A-2014-6-25-01
- Acronym
- TOP
- Status last verified
- Nov 2022
- First submitted
- 7 Dec 2014
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fassoulaki A, Paraskeva A, Patris K, Pourgiezi T, Kostopanagiotou G. Pressure applied on the extra 1 acupuncture point reduces bispectral index values and stress in volunteers. Anesth Analg. 2003 Mar;96(3):885-890. doi: 10.1213/01.ANE.0000048713.41657.D3.
PubMed 12598279Nayak S, Wenstone R, Jones A, Nolan J, Strong A, Carson J. Surface electrostimulation of acupuncture points for sedation of critically ill patients in the intensive care unit--a pilot study. Acupunct Med. 2008 Mar;26(1):1-7. doi: 10.1136/aim.26.1.1.
PubMed 18356793
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Propofol Consumption During General Anesthesia
- ClinicalTrials.gov ID
- NCT02314650
- Acronym / sponsor ID
- TOP / XJH-A-2014-6-25-01
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 25 Aug 2015 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 11 Dec 2014 (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.
The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous acupoint stimulation | Experimental | Other: acupoint stimulation, Other: electrodes attachedElectrical stimulation was given through electrodes attached to skin at Ximen and Shenmen acupoint during anesthesia |
| Non-acupoint stimulation | Placebo comparator | Other: non-acupoint stimulation, Other: electrodes attachedElectrical stimulation was given through electrodes attached to skin at shoulder (non-acupoint) during anesthesia |
| Control | Sham comparator | Other: electrodes attachedpatients were with electrodes attached but no stimulation was given |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia
- Patients with written informed consent
Key exclusion criteria (4 listed)
- Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease
- Patients with drug abuse
- Patients with disease of central nervous system
- Patients with renal or hepatic dysfunction
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 |
|---|---|---|
| acupoint stimulationstimulation was given at acupoints | Other | Transcutaneous acupoint stimulation |
| non-acupoint stimulationstimulation was given at non-acupoints | Other | Non-acupoint stimulation |
| electrodes attachedelectrode were attached to skin | Other | Control, Non-acupoint stimulation, Transcutaneous acupoint stimulation |
Primary outcome
propofol consumption
Time frame: from induction to the end of surgery,at an average of 1 hour
5 secondary outcomes
time to awake
Time frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
time to extubation
Time frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
effect site concentration of propofol at awake
Time frame: from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes
highest sedation score during stay at postanesthesia care unit
Time frame: from end of surgery to discharge from post anesthesia care unit, at an average of 1 hour
nausea and vomiting during stay at postanesthesia care unit
Time frame: 30min after surgery
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 14 Nov 2022.
- Results publication: PubMed 12598279Fassoulaki A, Paraskeva A, Patris K, Pourgiezi T, Kostopanagiotou G. Pressure applied on the extra 1 acupuncture point reduces bispectral index values and stress in volunteers. Anesth Analg. 2003 Mar;96(3):885-890. doi: 10.1213/01.ANE.0000048713.41657.D3.
- Results publication: PubMed 18356793Nayak S, Wenstone R, Jones A, Nolan J, Strong A, Carson J. Surface electrostimulation of acupuncture points for sedation of critically ill patients in the intensive care unit--a pilot study. Acupunct Med. 2008 Mar;26(1):1-7. doi: 10.1136/aim.26.1.1.
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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.
Zhihong LU, PhD principal investigator
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupoint stimulation, non-acupoint stimulation and electrodes attached in people with Anesthesia, run by Air Force Military Medical University, China 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 2 inclusion and 4 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 14 Nov 2022. 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?
propofol consumption (time frame: from induction to the end of surgery,at an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314650, which also lists 2 linked publications.
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 14 Nov 2022.