Clinical trial NCT05330494: Effects of Perioperative TEAS on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
Official title: Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Effect of TEAS on the Children' Pain and Agitation
Keywords: Transcutaneous acupoint electrical stimulation
adenoidectomy
tonsillectomy
pain
agitation
Lead sponsor: Xian Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2022-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adenoidectomy and tonsillectomy are generally performed during childhood to help reduce snoring and improve sleep or caused by recurrent infection.And insufficient analgesia may result in postoperative sore throat, difficulty swallowing, aspiration, delayed discharge, spasm, and agitation. Remedial analgesic drugs such as morphine and opioids may lead to postoperative respiration depression, desaturation and vomiting.Transcutaneous electrical acupoint stimulation (TEAS) is a peripheral stimulation, which is a modern therapy derived from traditional acupuncture. Relevant clinical trials show that it can effectively relieve pain, and has slight side-effects.However, most of these clinical trials are conducted in adults, and there have been few clinical trials involving children. For this reason, in line with good tolerance and less side effects of TEAS, ,this study is designed to enhance the therapeutic effect of adenoidectomy and tonsillectomy pain by means of taking advantage of the skin-sticking electro-acupuncture.It is also hoped that this study can certify if TEAS can reduce the amount and side effects of analgesic drugs, such as morphine, and improve the postoperative safety of children, and moreover, explore the possible mechanisms by which TEAS relieve pain in children.

Detailed description: Sample size The sample size estimation was based on the incidence of agitation in previous studies. It was selected for a type I error of 0.05, a power of 0.80, and the dropout rate 0f 0.2. The calculation was done through a website program (https://www.medsci.cn), and 200 patients should be included .

Randomization and blinding On arrival at the operating room, a simple randomization method will be used to make sure that the patient is randomly allocated to one of four groups at the 1:1:1:1 ratio.Investigator put the group information in four different envelopes. When the first envelope is extracted, the following patients intelligently extract the group from the remaining envelopes, and so on, until all four envelopes are extracted, and investigator repeat the process. The anesthesiologist who carried out the TEAS procedures and in charge of intraoperative anesthesia is aware of the assignment to group TEAS. But the outcome assessors responsible for collecting and analyzing the data are blind to patient treatment.

Procedure Before entering the operating room, intravenous (IV) access should be clear and no medication is given previously. After entering the operating room, electrocardiogram (ECG), pulse oxygen inundation (SpO2), noninvasive blood pressure (NIBP), SedLine and analgesia nociception index(ANI) are checked according to the manufacturer's recommendations . At the same time, the electrodes are placed at Hegu (LI4), Neiguan （PC 6）and Zusanli (ST36) of both sides.Anesthesia is induced with 2-3 mg/kg of propofol, 0.3 µg/kg of sufentanil. Meanwhile, 0.1 mg/kg of atropine and 0.2 mg/kg of dexamethasone are given to prevent postoperative nausea and oral secretions. After confirming the absence of a response to eye stimulus, 0.15 mg/kg of cis-atracurium is administered. Ventilation is conducted with a mask using 100% oxygen, and tracheal intubation is done after realizing the adequate depth of anesthesia. Next, to preserve the spectral edge frequency (SEF) between 14 and 20, anesthesia is maintained with the end-tidal concentration of sevoflurane 2-2.5 vol% and remifentanil at a dose of 0.2-0.3ug/kg/min during surgery, while ventilation is measured to sustain the end-tidal carbon dioxide (EtCO2) between 40 ± 5 mmHg. Furthermore, baseline hemodynamic variations are kept within a ±20% range.

Intervention patients are randomly divided into TEAS and control groups, and TEAS group is divided into three subgroups (S1, S2 and S3) according to the time of treatment started: S1 treatment initiate at 30 minutes before induction and last for 30min, S2 treatment initiate immediately after induction and stop at the end of surgery, S3 treatment initiate immediately after extubating and last for 30 minutes. The TEAS group receive TEAS treatment(disperse-dense waves; frequency, 2/100 Hz)on acupoints Hegu(LI4) , Neiguan(PC6) and Zusanli（ST 36）of both sides, and the present intensity(8～12 mA) is the maximum current that could be tolerated. Then, the TEAS treatment is administered twice a day (once in the morning and once in the afternoon) on the first and second postoperative day, which last for 30 minutes each time. And the control group is given all manipulations without electrical stimulation.

Statistical analyses Measurement data of normal distribution are reported as the mean ± SD. Categorical variables are analyzed through chi-squared test or the Fisher's exact probability test and presented as numbers (%). Comparisons between two groups are performed with Student's t-test. Repeated measurements were compared using repeated measure' ANOVA. For all tests, P\<0.05 is considered statistically significant.

Eligibility criteria: Inclusion Criteria:

1. the American Society of Anesthesiologists physical status Ⅰ and Ⅱ.
2. Ranging in age from 4 to 10.
3. Suffering from adenoid and/or tonsil hypertrophy
4. Preparing for elective surgery under general anesthesia with a signed written informed consent by parents..

Exclusion Criteria:

1. immunological, neurological, and hematological disorders
2. having any drug allergy or asthma, as well as allergic constitution
3. with congenital heart disease or various malignant arrhythmias
4. skin infections existing at acupoints and their surroundings
5. history of receiving acupuncture or electroacupuncture treatment
6. long-term use of analgesic or sedative drugs
7. used to having unilateral tonsil ablation
8. refusing to join the trial investigator
9. postoperative trachea spasm or laryngeal edema occurring

Primary outcomes:
measure: change from pain score within 48 hours after surgery
timeFrame: interval 5minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 48 hours after surgery
measure: change from agitation score within 48 hours after surgery
timeFrame: interval 5 minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 48 hours after surgery
Secondary outcomes:
measure: duration of anesthesia
timeFrame: Intraoperative (from the start of induction to endotracheal tube (EET) removal)
measure: duration of surgery
timeFrame: Intraoperative (from the insertion of the mouth gag to removal of the mouth gag)
measure: recovery time
timeFrame: Intraoperative (from sevoflurane discontinuation to spontaneous eye opening)
measure: extubation time
timeFrame: Intraoperative (from discontinuation of sevoflurane to tracheal extubation)
measure: PACU length of stay(PACU-LOS)
timeFrame: up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
measure: postoperative length of stay(PLOS)
timeFrame: from the date of operation to the date of discharge , an average of 3 days
measure: the concentration of serum interleukin-6 (IL-6), cortisol (COR) and β-endorphin(β-EP)
timeFrame: entering the operating room, 30minutes after extubation, 24 hours after surgery
measure: change from mean arterial pressure (MAP) on the day of surgery
timeFrame: Intraoperative (entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation)
measure: change from heart rate (HR) on the day of surgery
timeFrame: entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation
measure: change from analgesia nociception index(ANI) on the day of surgery
timeFrame: entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation
measure: the consumption of remifentanil
timeFrame: Intraoperative (From the beginning to the end of the operation)
measure: postoperative sufentanil rescue rate in PACU
timeFrame: up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
measure: the incidence of postoperative nausea and vomiting(PONV)
timeFrame: from the end of surgery to 48 hours after surgery
measure: postoperative sleep quality
timeFrame: 24hours and 48 hours after surgery
measure: complications
timeFrame: from end of surgery to 48 hours after operation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Children's Hospital
state: Shaanxi
Study officials:
affiliation: Xi 'an children's hospital
name: Fang Li Yang
role: STUDY_CHAIR
References: