Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse IncidentsNCT01700855
Electroacupuncture Anesthesia for Nasal Sinus Surgery and Mammaplasty
A study testing non-electroacupuncture and Electroacupuncture in people with Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty. Read more about this study
- Who is it for?
- Ages 29 to 60 years
- Conditions the study is for
- Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents
- What is being tested?
- non-electroacupuncture and Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Dec 2012
- 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 29 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- selective nasal sinus surgery
- selective mammaplasty
- patients who accept the follow-up and sign the informed consent
- ASA 1~2
Who cannot join
- emergent surgery
- pregnant or breast-feeding women
- coagulopathy
- history of gastrointestinal ulcer
- liver or renal dysfunction
- enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study
The purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.
Read the detailed description
Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc).
- Being tested
- non-electroacupuncture, Electroacupuncture
- Keywords
- Electroacupuncture, Analgesia, Anesthesia, Nasal septoplasty, Mammaplasty
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-electroacupunctureProcedure or surgery
Also called Sham
The same procedure as electroacupuncture except stimulation
ElectroacupunctureProcedure or surgery
Also called Electroacupuncture preconditioning, Electroacupuncture pretreatment, Transcutaneous electric nerve stimulation
Electrodes are applied to bilateral "Hegu(L14)" acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | Patients received electroacupuncture stimulation Receives: Procedure: Electroacupuncture |
| Non-electroacupuncture | Sham comparator | Patients received sham electroacupuncture Receives: Procedure: non-electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean infusion rate of intraoperative remifentanil and propofol
To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
Measured: during operation
Secondary outcomes (2)
Visual analogue scale
To assess whether EA pretreatment could help in alleviating acute post-operative pain.
Measured: post-operative 4h, 8h, 24h and 48h
Extubation time
To investigate the time from the end of propofol and remifentanil infusion to extubation. To assess whether EA pretreatment could shorten the extubation time.
Measured: postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse IncidentsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wangqiang, Xijing Hospital
- Investigators
- Qiang Wang, M.D., Ph.D., Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700855
- Sponsor's protocol ID
- mazuike-28
- Status last verified
- May 2012
- First submitted
- 3 Sep 2012
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.
PubMed 24576720
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture for Pain Relief in Patients With Nasal Sinus Surgery and Mammaplasty: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01700855
- Acronym / sponsor ID
- mazuike-28
- Keywords
- Electroacupuncture, Analgesia, Anesthesia, Nasal septoplasty, Mammaplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Oct 2012 (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 purpose of this study is to verify the intraoperative analgesia of electroacupuncture in patients undergoing selective nasal sinus surgery and mammaplasty.
Detailed description
Acupuncture therapy has been proved helpful in the patients suffering from various pain problems. And it is reported to be able to reduce the intraoperative anesthetic requirement. However, so far there is few evidence from randomized controlled studies to confirm the assistant anesthetic effect of acupuncture. Electroacupuncture (EA) is a modern non-invasive technique of traditional acupuncture. Compared to traditional acupuncture, EA is more practicable, more easily to be accepted by patients and operated by physicians. Nasal sinus surgery and mammaplasty, especially breast augmentation, mostly belong to the scope of day surgeries, which demand a rapid, smooth recovery from anesthesia with minimum adverse side effects (e.g.: pain, PONV, etc).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Procedure: ElectroacupuncturePatients received electroacupuncture stimulation |
| Non-electroacupuncture | Sham comparator | Procedure: non-electroacupuncturePatients received sham electroacupuncture |
Who may qualify
- Ages
- 29 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- selective nasal sinus surgery
- selective mammaplasty
- patients who accept the follow-up and sign the informed consent
- ASA 1~2
Key exclusion criteria (6 listed)
- emergent surgery
- pregnant or breast-feeding women
- coagulopathy
- history of gastrointestinal ulcer
- liver or renal 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 |
|---|---|---|
| non-electroacupunctureAlso: ShamThe same procedure as electroacupuncture except stimulation | Procedure or surgery | Non-electroacupuncture |
| ElectroacupunctureAlso: Electroacupuncture preconditioning, Electroacupuncture pretreatment, Transcutaneous electric nerve stimulationElectrodes are applied to bilateral "Hegu(L14)" acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate. | Procedure or surgery | Electroacupuncture |
Primary outcome
the mean infusion rate of intraoperative remifentanil and propofol
Time frame: during operation
To investigate the operative time and total volume of remifentanil and propofol used during operation, and then calculate the mean infusion rate. To assess whether intraoperative requirements for anesthetic drugs could be reduced by EA pretreatment.
2 secondary outcomes
Visual analogue scale
Time frame: post-operative 4h, 8h, 24h and 48h
Extubation time
Time frame: postoperation
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 11 Jul 2014.
- Derived from this study: PubMed 24576720Wang H, Xie Y, Zhang Q, Xu N, Zhong H, Dong H, Liu L, Jiang T, Wang Q, Xiong L. Transcutaneous electric acupoint stimulation reduces intra-operative remifentanil consumption and alleviates postoperative side-effects in patients undergoing sinusotomy: a prospective, randomized, placebo-controlled trial. Br J Anaesth. 2014 Jun;112(6):1075-82. doi: 10.1093/bja/aeu001. Epub 2014 Feb 26.
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.
Qiang Wang, M.D., Ph.D. study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-electroacupuncture and Electroacupuncture in people with Therapeutic (Nonsurgical) and Rehabilitative Anesthesiology Devices Associated With Adverse Incidents, run by Xijing Hospital 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 6 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 11 Jul 2014. 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?
the mean infusion rate of intraoperative remifentanil and propofol (time frame: during operation). 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 NCT01700855, which also lists 1 linked publication.
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 11 Jul 2014.