Transcutaneous Electrical Acupoint StimulationNCT05379660
Effects of TEAS on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy
A study testing transcutaneous electrical acupoint stimulation in people with Transcutaneous Electrical Acupoint Stimulation, run by Xian Children's Hospital.
Trial summary
With the development of surgical techniques, laparoscopic appendectomy has become a standard therapeutic procedure for acute appendicitis in many hospitals in recent years, which is considered as an effective and safe treatment option in children. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Transcutaneous Electrical Acupoint Stimulation
- What is being tested?
- transcutaneous electrical acupoint stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Apr 2023
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists grade I\&II,16kg/m2 ≤BMI≤30kg/m2, undergoing laparoscopic appendectomy
Who cannot join
- previous history of gastrointestinal surgery or abnormal anesthesia recovery, allergy, broken and infection skin at and around the related points, long-term use of analgesic and sedative drugs, presence of severe systemic disease,and the patients drop out or are unable to complete a full follow-up for any reason
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy
With the development of surgical techniques, laparoscopic appendectomy has become a standard therapeutic procedure for acute appendicitis in many hospitals in recent years, which is considered as an effective and safe treatment option in children. Even so, patients still experience gastrointestinal dysfunction after surgery, which is one of the most common complications in patients who have undergone major abdominal surgery. The application of laparoscopy reduces trauma in some degree, however, postoperative nausea and vomiting (PONV), abdominal distension, fart, and delayed bowel movement caused by postoperative gastrointestinal dysfunction(PGD), severely disturb patients and seriously affect the quality of patients' postoperative recovery. Previous studies have shown that the incidence of PGD can be as high as 10%-30%. For PGD, the main treatment options include the use of gastric dynamics promoting drug, non-steroidal anti-inflammatory drug, gastrointestinal (GI) decompression, nutritional support, and so forth. However, the effect of these treatments is limited, and there are varying degrees of adverse reactions, which indirectly leads to the low satisfaction of patients. Acupuncture is a form of traditional Chinese medicine and has unique advantages in the treatment of PGD, which have gradually obtained more acceptance from physicians as an alternative therapy. While transcutaneous electrical acupoint stimulation (TEAS) is one of the acupuncture-related technologies and can allow for accurate control of stimulation parameters. For this reason, it is helpful for quantitative research and widely practiced in China. Many studies have shown that TEAS combining with anesthetics can significantly enhance the analgesic effect and reduce the dosage of anesthetics, and can offer certain beneficial effects, such as alleviating preoperative anxiety and reducing postoperative pain and PONV by lessening need for anesthetic usage. It also has been found to help protect the brain, heart and other tissues, with positive benefits for gastrointestinal function by regulating vasoactive intestinal peptide levels. In practice, however, the current TEAS study focused on adults，with relatively little research on their use in children. Because of that, we applied TEAS for use in our study to observe the effect of TEAS in children's laparoscopic surgery and explore its possible mechanism.
- Being tested
- transcutaneous electrical acupoint stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationDevice
Basing on the theory of traditional Chinese medicine, bilateral Zusanli (ST 36), Shangjuxu (ST 37) and Sanyinjiao (SP 6) are elected as the acupuncture points,the electrode pads with wire are attached to the corresponding acupoints, which are connected with Hwato electric acupuncture treatment instrument,TEAS stimulation uses a dense-dispersed wave with frequencies of 2 and 100 Hz alternating every 3 s, and the intensity 5 ~ 12mA,on the first and second days after surgery, the doctor who is responsible for acupuncture will arrive at the ward in the morning and afternoon to administer TEAS stimulation at the same acupoints for 30 min in the TEAS groups
| Study group | Role | What they receive |
|---|---|---|
| T1 treatment group | Experimental | TEAS initiates at 30 minutes before induction and lasts for 30 minutes Receives: Device: transcutaneous electrical acupoint stimulation |
| T2 treatment group | Experimental | TEAS initiates immediately after skin incision and lasts for 30 minutes Receives: Device: transcutaneous electrical acupoint stimulation |
| T3 treatment group | Experimental | TEAS initiates immediately after extubating and lasts for 30 minutes Receives: Device: transcutaneous electrical acupoint stimulation |
| control group | No intervention | Electrodes are placed on the same acupoints, but no current is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to first bowel sound
It was heard by the same researcher , and defined as the first time point at which the regular bowel sounds (more than two sounds every minute) are first heard after surgery.
Measured: until the time point at which the regular bowel sounds are first heard after surgery up to 1 day
Secondary outcomes (6)
the time to first passage of flatus
This information was obtained with the help of nurse staff and caregivers through questionnaires which were filled out once daily.
Measured: an average of 24 hours,from the end of surgery to the time of the patient's first passage of flatus
the time to first passage of defecation
This information was obtained with the help of nurse staff and caregivers through questionnaires which were filled out once daily.
Measured: an average of 24 hours,from the end of surgery to the the time of the patient's first passage of defecation,
the first time to normal diet intake
It was defined as the time at which the patient was given normal diet after defecation without nausea or vomiting
Measured: within 48 hours after surgery,from the end of surgery to the time when the patient was given normal diet
the first time to mobilization
It was defined as the time at which the patient is first able to leave bed
Measured: within 48 hours after surgery,from the end of surgery to the time when the patient is first able to leave bed
gastroenterological hormones
To observe changes in serum levels of gastroenterological hormones ,including serotonin (5-HT), vasoactive intestinal peptide (VIP) and Substance P (SP),venous blood(4ml) will be collected from patients
Measured: three time points: before induction of anesthesia, the end of the surgery and the first day after the operation
inflammatory factors
To observe changes in serum levels of inflammatory factors,which contain tumor necrosis factor (TNF)-α and interleukin-10 (IL-10),venous blood(4ml) will be collected from patients
Measured: three time points: before induction of anesthesia, the end of the surgery and the first day after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Acupoint StimulationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xian Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fang Li Yang, Study director, Xi 'an children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379660
- Sponsor's protocol ID
- 2021-015-01
- Status last verified
- May 2022
- First submitted
- 4 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery of Intestinal Function in Children Undergoing Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT05379660
- Acronym / sponsor ID
- 2021-015-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xian Children's HospitalOther government
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 18 May 2022 (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.
With the development of surgical techniques, laparoscopic appendectomy has become a standard therapeutic procedure for acute appendicitis in many hospitals in recent years, which is considered as an effective and safe treatment option in children. Even so, patients still experience gastrointestinal dysfunction after surgery, which is one of the most common complications in patients who have undergone major abdominal surgery. The application of laparoscopy reduces trauma in some degree, however, postoperative nausea and vomiting (PONV), abdominal distension, fart, and delayed bowel movement caused by postoperative gastrointestinal dysfunction(PGD), severely disturb patients and seriously affect the quality of patients' postoperative recovery. Previous studies have shown that the incidence of PGD can be as high as 10%-30%. For PGD, the main treatment options include the use of gastric dynamics promoting drug, non-steroidal anti-inflammatory drug, gastrointestinal (GI) decompression, nutritional support, and so forth. However, the effect of these treatments is limited, and there are varying degrees of adverse reactions, which indirectly leads to the low satisfaction of patients. Acupuncture is a form of traditional Chinese medicine and has unique advantages in the treatment of PGD, which have gradually obtained more acceptance from physicians as an alternative therapy. While transcutaneous electrical acupoint stimulation (TEAS) is one of the acupuncture-related technologies and can allow for accurate control of stimulation parameters. For this reason, it is helpful for quantitative research and widely practiced in China. Many studies have shown that TEAS combining with anesthetics can significantly enhance the analgesic effect and reduce the dosage of anesthetics, and can offer certain beneficial effects, such as alleviating preoperative anxiety and reducing postoperative pain and PONV by lessening need for anesthetic usage. It also has been found to help protect the brain, heart and other tissues, with positive benefits for gastrointestinal function by regulating vasoactive intestinal peptide levels. In practice, however, the current TEAS study focused on adults，with relatively little research on their use in children. Because of that, we applied TEAS for use in our study to observe the effect of TEAS in children's laparoscopic surgery and explore its possible mechanism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T1 treatment group | Experimental | Device: transcutaneous electrical acupoint stimulationTEAS initiates at 30 minutes before induction and lasts for 30 minutes |
| T2 treatment group | Experimental | Device: transcutaneous electrical acupoint stimulationTEAS initiates immediately after skin incision and lasts for 30 minutes |
| T3 treatment group | Experimental | Device: transcutaneous electrical acupoint stimulationTEAS initiates immediately after extubating and lasts for 30 minutes |
| control group | No intervention | –Electrodes are placed on the same acupoints, but no current is given |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists grade I\&II,16kg/m2 ≤BMI≤30kg/m2, undergoing laparoscopic appendectomy
Key exclusion criteria (1 listed)
- previous history of gastrointestinal surgery or abnormal anesthesia recovery, allergy, broken and infection skin at and around the related points, long-term use of analgesic and sedative drugs, presence of severe systemic disease,and the patients drop out or are unable to complete a full follow-up for any reason
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 |
|---|---|---|
| transcutaneous electrical acupoint stimulationBasing on the theory of traditional Chinese medicine, bilateral Zusanli (ST 36), Shangjuxu (ST 37) and Sanyinjiao (SP 6) are elected as the acupuncture points,the electrode pads with wire are attached to the corresponding acupoints, which are connected with Hwato electric acupuncture treatment instrument,TEAS stimulation uses a dense-dispersed wave with frequencies of 2 and 100 Hz alternating every 3 s, and the intensity 5 ~ 12mA,on the first and second days after surgery, the doctor who is responsible for acupuncture will arrive at the ward in the morning and afternoon to administer TEAS stimulation at the same acupoints for 30 min in the TEAS groups | Device | T1 treatment group, T2 treatment group, T3 treatment group |
Primary outcome
the time to first bowel sound
Time frame: until the time point at which the regular bowel sounds are first heard after surgery up to 1 day
It was heard by the same researcher , and defined as the first time point at which the regular bowel sounds (more than two sounds every minute) are first heard after surgery.
6 secondary outcomes
the time to first passage of flatus
Time frame: an average of 24 hours,from the end of surgery to the time of the patient's first passage of flatus
the time to first passage of defecation
Time frame: an average of 24 hours,from the end of surgery to the the time of the patient's first passage of defecation,
the first time to normal diet intake
Time frame: within 48 hours after surgery,from the end of surgery to the time when the patient was given normal diet
the first time to mobilization
Time frame: within 48 hours after surgery,from the end of surgery to the time when the patient is first able to leave bed
gastroenterological hormones
Time frame: three time points: before induction of anesthesia, the end of the surgery and the first day after the operation
inflammatory factors
Time frame: three time points: before induction of anesthesia, the end of the surgery and the first day after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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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.
Fang Li Yang study director
Xi 'an children's hospital
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation in people with Transcutaneous Electrical Acupoint Stimulation, run by Xian Children's Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Hi Wu (+8618092695276, 1922703776@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to first bowel sound (time frame: until the time point at which the regular bowel sounds are first heard after surgery up to 1 day). 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 May 2022.