Perioperative AnalgesiaNCT06748898
Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Responses to Tracheal Intubation Under General Anesthesia
A study testing TENS-WAA and non TENS-WAA in people with Perioperative Analgesia and General Anaesthesia, run by Changhai Hospital at 1 site in China.
Trial summary
During endotracheal tube insertion under general anesthesia, sympathetic nerve activity increases, which leads to increased heart rate, increased blood pressure, and increased catecholamine levels in the blood. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Perioperative Analgesia, General Anaesthesia
- What is being tested?
- TENS-WAA and non TENS-WAA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2025to 14 Nov 2025
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-64 years old;
- ASA grade I-Ⅲ;
- BMI≤30kg/m2.
Who cannot join
- Patients predicted to have difficult airways or those experiencing unsuccessful intubation processes;
- Individuals with psychiatric disorders, cognitive impairments, or other conditions that preclude cooperation;
- Patients who have received acupuncture treatment within the past three months or are undergoing routine acupuncture therapy;
- Individuals with a history of severe cardiovascular disease, hyperthyroidism, or asthma;
- Patients with contraindications to transcutaneous electrical nerve stimulation (TENS), including those with pacemakers, metallic implants, allergies to surface electrodes, skin sensory disorders, skin lesions, scars, or unhealed adhesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Cardiovascular Response After Tracheal Intubation Under General Anesthesia
During endotracheal tube insertion under general anesthesia, sympathetic nerve activity increases, which leads to increased heart rate, increased blood pressure, and increased catecholamine levels in the blood. It is important for patients to maintain hemodynamic stability during anesthesia induction and ultimately mitigate the cardiovascular stress response associated with tracheal intubation.
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory (TENS-WAA) is a non-invasive pain treatment method, It has the advantages of easy wearing, concentrated treatment site, safe treatment and needle-free. To date, due to the lack of large-scale clinical use of TENS-WAA, only a few studies have reported the use of TENS-WAA for postoperative pain rehabilitation, especially for perioperative pain management. The aim of this study is to evaluate the median effective dose (ED50) of TENS-WAA for remifentanil inhibiting responses to tracheal intubation under general anesthesia, and to provide a reliable basis for its clinical promotion.
- Conditions
- Perioperative Analgesia, General Anaesthesia
- Being tested
- TENS-WAA, non TENS-WAA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS-WAAOther
Before anesthesia induction, two paired of electrode pads will be placed on the upper area 1 and 2 with the skin of the treatment area exposed, and the upper and lower juxtaposition method will be adopted. The electrodes were placed close to the skin and connected with TENStem eco basic (Wuxi Jiajian Medical Device Co., Ltd.). Upper area 2 is at the middle of the palmar side of the forearm, between the palmaris longus and flexor carpi radialis.Upper area 1 is between the ulnar border on the little finger side and the flexor carpi ulnaris tendon.Stimulation parameters of TENS-WAA are alternating dense-disperse wave with a frequency of 2Hz and a pulse width of 200μs, and a frequency of 100Hz with a pulse width of 150μs, alternating every 3 seconds ，intensity required to reachthe maximum tolerable level without causing pain, continuous stimulation until the end of surgery.
non TENS-WAAOther
Before anesthesia induction, two paired of electrode pads will be placed on the same position without current stimulation.
| Study group | Role | What they receive |
|---|---|---|
| T group | Experimental | Patients received TENS-WAA with current stimulation Receives: Other: TENS-WAA |
| C group | Sham comparator | Patients received TENS-WAA without current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the half maximum effective concentration (EC50) of remifentanil
Dixon's up-and-down method was used to determine the remifentanil concentration, starting from 3.0 ng/mL (step size of 0.2 ng/mL). After obtaining 7 infection points from positive to negative endotracheal intubation reactions, patient recruitment was terminated. A positive response to endotracheal intubation was defned as MAP 15% above the basal level or HR 15% above the basal level within 2 min of endotracheal intubation. The EC50 of remifentanil Ce was determined by calculating the average of the midpoint dose of all independent pairs of patients after six crossover points were obtained.
Measured: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.
Secondary outcomes (6)
The time required for tracheal intubation
defined as the time from the start of intubation to inflation of the bronchial tube cuff
Measured: The time consumed by this procedure was recorded from the beginning of intubation until completion of inflation of the endotracheal tube cuff
Nausea and vomiting
Postoperative nausea and vomiting was assessed by visual analogue scale (VAS) : a 10-cm ruler was used as a scale, with 0 at one end indicating no nausea and vomiting, and 10 at the other end indicating the most severe nausea and vomiting that could not be tolerated (1-4 as mild, 5-6 as moderate, 7-10 as severe).
Measured: 24 hour after surgery
The dynamic VAS score
Independent investigators will assess the postoperative dynamic pain (pain during activities or coughing) by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score.
Measured: 24 hour after surgery
QoR-15 questionnaire
The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery
Measured: 24 hour after surgery
Postoperative airway complications
Postoperative airway complications such as hoarseness, sore throat, and difficulty in pronunciation are assessed by researchers during postoperative follow-up visits to check for the presence of related complications and to record the findings
Measured: 24 hour after surgery
Postoperative static pain (pain at rest)
Postoperative static pain (pain at rest) will be quantified by utilizing a visual analogue scale (VAS) ranging from 0 to 10. The two ends of the straight line represent "no pain at all" and "the worst pain imaginable," respectively. Patients are required to mark their corresponding position on the line based on their perception of pain, and the numerical value corresponding to this position serves as the patient's pain score.
Measured: 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 Feb 2025
- Primary completion14 Nov 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748898
- Sponsor's protocol ID
- TENS-WAA
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on EC50 of Remifentanil Inhibiting Cardiovascular Response After Tracheal Intubation Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06748898
- Acronym / sponsor ID
- TENS-WAA
- Conditions
- Perioperative Analgesia, General Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- 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.
During endotracheal tube insertion under general anesthesia, sympathetic nerve activity increases, which leads to increased heart rate, increased blood pressure, and increased catecholamine levels in the blood. It is important for patients to maintain hemodynamic stability during anesthesia induction and ultimately mitigate the cardiovascular stress response associated with tracheal intubation.
Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory (TENS-WAA) is a non-invasive pain treatment method, It has the advantages of easy wearing, concentrated treatment site, safe treatment and needle-free. To date, due to the lack of large-scale clinical use of TENS-WAA, only a few studies have reported the use of TENS-WAA for postoperative pain rehabilitation, especially for perioperative pain management. The aim of this study is to evaluate the median effective dose (ED50) of TENS-WAA for remifentanil inhibiting responses to tracheal intubation under general anesthesia, and to provide a reliable basis for its clinical promotion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T group | Experimental | Other: TENS-WAAPatients received TENS-WAA with current stimulation |
| C group | Sham comparator | –Patients received TENS-WAA without current stimulation |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-64 years old;
- ASA grade I-Ⅲ;
- BMI≤30kg/m2.
Key exclusion criteria (5 listed)
- Patients predicted to have difficult airways or those experiencing unsuccessful intubation processes;
- Individuals with psychiatric disorders, cognitive impairments, or other conditions that preclude cooperation;
- Patients who have received acupuncture treatment within the past three months or are undergoing routine acupuncture therapy;
- Individuals with a history of severe cardiovascular disease, hyperthyroidism, or asthma;
- Patients with contraindications to transcutaneous electrical nerve stimulation (TENS), including those with pacemakers, metallic implants, allergies to surface electrodes, skin sensory disorders, skin lesions, scars, or unhealed adhesions.
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 |
|---|---|---|
| TENS-WAABefore anesthesia induction, two paired of electrode pads will be placed on the upper area 1 and 2 with the skin of the treatment area exposed, and the upper and lower juxtaposition method will be adopted. The electrodes were placed close to the skin and connected with TENStem eco basic (Wuxi Jiajian Medical Device Co., Ltd.). Upper area 2 is at the middle of the palmar side of the forearm, between the palmaris longus and flexor carpi radialis.Upper area 1 is between the ulnar border on the little finger side and the flexor carpi ulnaris tendon.Stimulation parameters of TENS-WAA are alternating dense-disperse wave with a frequency of 2Hz and a pulse width of 200μs, and a frequency of 100Hz with a pulse width of 150μs, alternating every 3 seconds ，intensity required to reachthe maximum tolerable level without causing pain, continuous stimulation until the end of surgery. | Other | T group |
| non TENS-WAABefore anesthesia induction, two paired of electrode pads will be placed on the same position without current stimulation. | Other | – |
Primary outcome
the half maximum effective concentration (EC50) of remifentanil
Time frame: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.
Dixon's up-and-down method was used to determine the remifentanil concentration, starting from 3.0 ng/mL (step size of 0.2 ng/mL). After obtaining 7 infection points from positive to negative endotracheal intubation reactions, patient recruitment was terminated. A positive response to endotracheal intubation was defned as MAP 15% above the basal level or HR 15% above the basal level within 2 min of endotracheal intubation. The EC50 of remifentanil Ce was determined by calculating the average of the midpoint dose of all independent pairs of patients after six crossover points were obtained.
6 secondary outcomes
The time required for tracheal intubation
Time frame: The time consumed by this procedure was recorded from the beginning of intubation until completion of inflation of the endotracheal tube cuff
Nausea and vomiting
Time frame: 24 hour after surgery
The dynamic VAS score
Time frame: 24 hour after surgery
QoR-15 questionnaire
Time frame: 24 hour after surgery
Postoperative airway complications
Time frame: 24 hour after surgery
Postoperative static pain (pain at rest)
Time frame: 24 hour 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 18 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS-WAA and non TENS-WAA in people with Perioperative Analgesia and General Anaesthesia, run by Changhai 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 5 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 18 Dec 2025. 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 half maximum effective concentration (EC50) of remifentanil (time frame: The remifentanil concentration was recorded for 2 minutes after successful tracheal intubation.). 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 18 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.