StressNCT02533388
Effects of TEAS on Stress Response During Extubation of General Anesthesia in Elderly Patients
A study testing Hwato Electronic Acupuncture Treatment Instrument in people with Stress, run by Shengjing Hospital at 1 site in China.
Trial summary
Elderly patients have an increased risk of stress responses during extubation after general anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses during extubation after general anaesthesia remains challenging for the anaesthesiologist. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Hwato Electronic Acupuncture Treatment Instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Mar 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA Ⅱ～Ⅲ
- aged 60-70years
- scheduled for elective supratentorial craniotomy under general anaesthesia
Who cannot join
- past or current history of cardiovascular and/or cerebrovascular diseases
- diabetes
- pre-existing liver, lung or kidney dysfunction
- psychiatric disorders
- potentially difficult airway
- previous acupuncture treatment
- infection at the stimulus sites
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China medical university
Shenyang, Liaoning, 110000
About this study
Official title: Effects of Transcutaneous Electrical Acupoint Stimulation on the Stress Response During Extubation After General Anesthesia in Elderly Patients Undergoing Elective Supratentorial Craniotomy
Elderly patients have an increased risk of stress responses during extubation after general anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses during extubation after general anaesthesia remains challenging for the anaesthesiologist. In this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly patients who underwent elective supratentorial craniotomy under general anaesthesia.
Read the detailed description
A total of 100 elderly patients scheduled for elective supratentorial craniotomy under propofol-remifentanil total intravenous anaesthesia were randomly divided to either TEAS group (received stimulation at LI4, PC6, LU7, LU5, LI18 and ST9 acupoints, 2/10Hz, 6-15 mA) or Sham group (received no stimulation). The primary outcomes were the haemodynamic parameters and plasma concentrations of epinephrine (E), norepinephrine (NE) and cortisol (Cor). The secondary outcomes were the consumption of remifentanil and propofol, the time from discontinuation of anesthetics to extubation and reorientation, extubation quality score, the quality of postoperative recovery and postoperative complications.
- Conditions
- Stress
- Being tested
- Hwato Electronic Acupuncture Treatment Instrument, Placebo
- Keywords
- transcutaneous electrical acupoint stimulation, stress response
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hwato Electronic Acupuncture Treatment InstrumentDevice
Thirty minutes prior to the induction of anaesthesia, the patients in the TEAS group started to receive TEAS by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model No.: SDZ-II, Suzhou Medical Appliances Co., Ltd., Suzhou, China) to the right hand, forearm and neck by an experienced acupuncturist at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints. TEAS was peformed with an alternate dense-disperse frequency of 2 and10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, The stimulus continued until 5 min before the end of surgery.
PlaceboDevice
The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.
| Study group | Role | What they receive |
|---|---|---|
| Electrical acupoint stimulation | Experimental | Electrical acupoint stimulation at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints, Stimulus frequency was an alternate dense-disperse frequency of 2/10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, which was adjusted to maintain a slight twitching of the regional muscles according to individual maximum tolerance. Receives: Device: Hwato Electronic Acupuncture Treatment Instrument |
| Sham stimulation | Sham comparator | Sham stimulation only connected to the apparatus, but electronic stimulation was not applied. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Non-invasive arterial blood pressure
Non-invasive arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Measured: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in plasma concentrations of epinephrine
plasma concentrations of epinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Measured: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in mean arterial blood pressure
Mean arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Measured: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in heart rate
Heart rate was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Measured: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in norepinephrine
Norepinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Measured: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in cortisol
Cortisol was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Measured: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Secondary outcomes (6)
Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)
Measured: From discontinuation of anaesthetic drugs to 24 h after surgery
the time to extubation,the time to reorientation
Measured: From discontinuation of anaesthetic drugs to 24 h after surgery
the quality of extubation was evaluated by a 5-point Extubation Quality Score
Measured: From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of remifentanil that used throughout the surgery
Measured: From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of propofol that used throughout the surgery
Measured: From discontinuation of anaesthetic drugs to 24 h after surgery
Postoperative complications,like cough,agitation,nausea and vomiting
Cough was assessed using a four-point scale；Agitation was evaluated using the Ricker Sedation-Agitation Scale；Nausea was defined as the patient complained of an unpleasant sensation with the urgency to vomit. Vomiting was defined as the forceful expulsion of gastric contents from the patient's mouth.
Measured: From discontinuation of anaesthetic drugs to 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao Zhu, doctor, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533388
- Sponsor's protocol ID
- TEAS on stress
- Status last verified
- Mar 2017
- First submitted
- 4 Jun 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Acupoint Stimulation on the Stress Response During Extubation After General Anesthesia in Elderly Patients Undergoing Elective Supratentorial Craniotomy
- ClinicalTrials.gov ID
- NCT02533388
- Acronym / sponsor ID
- TEAS on stress
- Conditions
- Stress
- Keywords
- transcutaneous electrical acupoint stimulation, stress response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Aug 2015 (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.
Elderly patients have an increased risk of stress responses during extubation after general anaesthesia for an elective supratentorial craniotomy. How to decrease the stress responses during extubation after general anaesthesia remains challenging for the anaesthesiologist. In this study, we aimed to investigate whether transcutaneous electrical acupoint stimulation (TEAS) might decrease the stress responses and improve the quality of recovery in the elderly patients who underwent elective supratentorial craniotomy under general anaesthesia.
Detailed description
A total of 100 elderly patients scheduled for elective supratentorial craniotomy under propofol-remifentanil total intravenous anaesthesia were randomly divided to either TEAS group (received stimulation at LI4, PC6, LU7, LU5, LI18 and ST9 acupoints, 2/10Hz, 6-15 mA) or Sham group (received no stimulation). The primary outcomes were the haemodynamic parameters and plasma concentrations of epinephrine (E), norepinephrine (NE) and cortisol (Cor). The secondary outcomes were the consumption of remifentanil and propofol, the time from discontinuation of anesthetics to extubation and reorientation, extubation quality score, the quality of postoperative recovery and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical acupoint stimulation | Experimental | Device: Hwato Electronic Acupuncture Treatment InstrumentElectrical acupoint stimulation at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints, Stimulus frequency was an alternate dense-disperse frequency of 2/10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, which was adjusted to maintain a slight twitching of the regional muscles according to individual maximum tolerance. |
| Sham stimulation | Sham comparator | Device: PlaceboSham stimulation only connected to the apparatus, but electronic stimulation was not applied. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA Ⅱ～Ⅲ
- aged 60-70years
- scheduled for elective supratentorial craniotomy under general anaesthesia
Key exclusion criteria (7 listed)
- past or current history of cardiovascular and/or cerebrovascular diseases
- diabetes
- pre-existing liver, lung or kidney dysfunction
- psychiatric disorders
- potentially difficult airway
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 |
|---|---|---|
| Hwato Electronic Acupuncture Treatment InstrumentThirty minutes prior to the induction of anaesthesia, the patients in the TEAS group started to receive TEAS by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model No.: SDZ-II, Suzhou Medical Appliances Co., Ltd., Suzhou, China) to the right hand, forearm and neck by an experienced acupuncturist at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints. TEAS was peformed with an alternate dense-disperse frequency of 2 and10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, The stimulus continued until 5 min before the end of surgery. | Device | Electrical acupoint stimulation |
| PlaceboThe patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied. | Device | Sham stimulation |
Primary outcome
Change in Non-invasive arterial blood pressure
Time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Non-invasive arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in plasma concentrations of epinephrine
Time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
plasma concentrations of epinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in mean arterial blood pressure
Time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Mean arterial blood pressure was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in heart rate
Time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Heart rate was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in norepinephrine
Time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Norepinephrine was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Change in cortisol
Time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
Cortisol was recorded before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation
6 secondary outcomes
Postoperative quality of recovery assessed by Quality of Recovery-40 questionnaire(QoR-40)
Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery
the time to extubation,the time to reorientation
Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery
the quality of extubation was evaluated by a 5-point Extubation Quality Score
Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of remifentanil that used throughout the surgery
Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery
The total amount of propofol that used throughout the surgery
Time frame: From discontinuation of anaesthetic drugs to 24 h after surgery
Postoperative complications,like cough,agitation,nausea and vomiting
Time frame: From discontinuation of anaesthetic drugs to 24 h 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 Mar 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.
Junchao Zhu, doctor study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hwato Electronic Acupuncture Treatment Instrument in people with Stress, run by Shengjing 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 3 inclusion and 7 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 Mar 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?
Change in Non-invasive arterial blood pressure (time frame: Before the onset of TEAS,prior to induction, at the end of surgery, immediately after extubation, and 5 and 10 min after extubation). The study lists 6 primary outcomes in all. 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 14 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.