Postoperative ComplicationsAIDNCT02239159
Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients
A study testing TES(transcutaneous electric stimulation) in people with Postoperative Complications and Surgery, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
The investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Complications, Surgery
- What is being tested?
- TES(transcutaneous electric stimulation)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 748 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Oct 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provide written informed consent
- Age ≥65 years of age
- Elective digestive surgery under general anesthesia
Who cannot join
- ASA(American Society of Anesthesiologists) status> Ⅲ
- Patients undergoing surgery within 12 h of admission to hospital
- Patients undergoing surgery of the chest
- Patients suffered from neurologic disorder or impaired mental state
- Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
- Patients with experience of transcutaneous electrical stimulation treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital,Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial
The investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. And TEAS may induce the production of endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators believe this intervention will reduce the subsequent incidence, duration and severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after digestive surgery in elderly patients .
Read the detailed description
Patients older than 65 years old are at higher risk of postoperative morbidity and mortality. With the increasing number of old patients scheduled for digestive surgery, exploring methods to decrease postoperative morbidity is very important. Noninvasive methods may be easier to clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to decrease need for general anesthetics during anesthesia, and to alleviate systemic inflammatory response. Considering the morbidity and mortality after surgery is closely related to use of anesthetics and inflammatory response,TEAS may be a good selection for improving postoperative outcomes.Among the postoperative complications, pulmonary complication and systemic inflammatory response syndrome is with higher incidence, so we will focus on these two complications in our study.
- Conditions
- Postoperative Complications, Surgery
- Being tested
- TES(transcutaneous electric stimulation)
- Keywords
- transcutaneous electric acupoint stimulation, elderly patients
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TES(transcutaneous electric stimulation)Other
Stimulation will be given through electrodes attached to the skin
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Electrodes will be attached, but stimulation will not be given |
| Non-acupoint TES | Sham comparator | TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints Receives: Other: TES(transcutaneous electric stimulation) |
| Acupoint TES | Experimental | Transcutaneous stimulation will be given through acupoints Receives: Other: TES(transcutaneous electric stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability
Measured: participants will be followed from the end of the surgery to 30 days after surgery
Secondary outcomes (5)
Number of participants died of all causes
Measured: Participants will be followed from the end of the surgery to 30 days after surgery
Length of ICU stay
Measured: participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Number of participants with ICU admission
Measured: participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Number of participants with Systemic Inflammatory Response Syndrome(SIRS)
Measured: Participants will be followed from the end of the surgery to 30 days after surgery
Length of hospital stay
Measured: participants will be followed for the duration of hospital stay after surgery, an expected average of 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 748 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
- Lize Xiong, PhD, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239159
- Sponsor's protocol ID
- XJH-A-2014-02-21-1
- Acronym
- AID
- Status last verified
- Jul 2017
- First submitted
- 6 Apr 2014
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02239159
- Acronym / sponsor ID
- AID / XJH-A-2014-02-21-1
- Conditions
- Postoperative Complications, Surgery
- Keywords
- transcutaneous electric acupoint stimulation, elderly patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Sep 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 investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. And TEAS may induce the production of endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators believe this intervention will reduce the subsequent incidence, duration and severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after digestive surgery in elderly patients .
Detailed description
Patients older than 65 years old are at higher risk of postoperative morbidity and mortality. With the increasing number of old patients scheduled for digestive surgery, exploring methods to decrease postoperative morbidity is very important. Noninvasive methods may be easier to clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to decrease need for general anesthetics during anesthesia, and to alleviate systemic inflammatory response. Considering the morbidity and mortality after surgery is closely related to use of anesthetics and inflammatory response,TEAS may be a good selection for improving postoperative outcomes.Among the postoperative complications, pulmonary complication and systemic inflammatory response syndrome is with higher incidence, so we will focus on these two complications in our study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Electrodes will be attached, but stimulation will not be given |
| Non-acupoint TES | Sham comparator | Other: TES(transcutaneous electric stimulation)TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints |
| Acupoint TES | Experimental | Other: TES(transcutaneous electric stimulation)Transcutaneous stimulation will be given through acupoints |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent
- Age ≥65 years of age
- Elective digestive surgery under general anesthesia
Key exclusion criteria (6 listed)
- ASA(American Society of Anesthesiologists) status> Ⅲ
- Patients undergoing surgery within 12 h of admission to hospital
- Patients undergoing surgery of the chest
- Patients suffered from neurologic disorder or impaired mental state
- Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints
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 |
|---|---|---|
| TES(transcutaneous electric stimulation)Stimulation will be given through electrodes attached to the skin | Other | Acupoint TES, Non-acupoint TES |
Primary outcome
Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability
Time frame: participants will be followed from the end of the surgery to 30 days after surgery
5 secondary outcomes
Number of participants died of all causes
Time frame: Participants will be followed from the end of the surgery to 30 days after surgery
Length of ICU stay
Time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Number of participants with ICU admission
Time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days
Number of participants with Systemic Inflammatory Response Syndrome(SIRS)
Time frame: Participants will be followed from the end of the surgery to 30 days after surgery
Length of hospital stay
Time frame: participants will be followed for the duration of hospital stay after surgery, an expected average of 7days
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 7 Jul 2017.
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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.
Lize Xiong, PhD study chair
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 TES(transcutaneous electric stimulation) in people with Postoperative Complications and Surgery, 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 3 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 7 Jul 2017. 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?
Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability (time frame: participants will be followed from the end of the surgery to 30 days after surgery). 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 7 Jul 2017.