General Anesthetics ToxicityDZDXEQFWQMSHZDNCT05924854
The Influence of Electroacupuncture on Postoperative Agitation of Pediatrics Undergoing Sevoflurane General Anesthesia
A study testing electroacupuncture in people with General Anesthetics Toxicity and Postoperative Cognitive Dysfunction, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Postoperative agitation is a common complication in pediatric anesthesia, with an incidence ranging from 10% to 80%. Common surgical procedures in children include tonsillectomy, adenoidectomy, insidious penis prolongation and circumcision, etc. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- General Anesthetics Toxicity, Postoperative Cognitive Dysfunction, Electroacupuncture
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jun 2024
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4-13 years old, both sexes;
- Tonsillectomy, adenoidectomy, concealed penis, and circumcision were planned under sevoflurane intravenous inhalation combined general anesthesia;
- The weight of the children was 10-60kg;
- The child had no history of allergy or mental disease.
- No respiratory tract infection within two weeks;
- No infection at the puncture site;
- There was no significant difference in body weight, age and operation time between the electroacupuncture group (E group) and the sevoflurane general anesthesia group（S group）.
- The informed consent was signed by the legal guardian of the patient before surgery.
Who cannot join
- Age < 4 years old, age > 13 years old;
- Body weight < 10kg, body weight > 60kg;
- The child has a history of heart disease, asthma, mental disease, and major surgery;
- A history of respiratory infection in the past two weeks;
- Non-electroacupuncture indications;
- Infection at the acupuncture site;
Show all 10Show fewer
- Patients with liver and kidney insufficiency, cardiopulmonary insufficiency;
- Those with allergic constitution (allergic to two or more substances);
- Persons with legal disabilities;
- Refusal to sign the consent form;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410007
About this study
Official title: The Influence of Electroacupuncture on Postoperative Agitation of Sevoflurane Inhalation Combined With Intravenous Anesthesia in Pediatrics: an Experimental, Single-center Clinical Study
Postoperative agitation is a common complication in pediatric anesthesia, with an incidence ranging from 10% to 80%. Common surgical procedures in children include tonsillectomy, adenoidectomy, insidious penis prolongation and circumcision, etc. Postoperative delirium and agitation is a clinical emergency, and can have detrimental effects on the child's health. The primary clinical manifestations include disorganized movements, moaning, incoherent speech, confusion and paranoid characters, inability to be concentrated, and irritability, obstinacy or uncooperative; all these would increase the risks of falling out of bed, possible fractures, and all kinds of tube loss. These symptoms would sustain postoperative recovery significantly and pose a possible long-term neurological dysfunction. As a result, an extended hospitalization, elevated in-hospital mortality rate, escalated medical expenses, heightened risk of cognitive impairment, reduced quality of life, and increased incidence of postoperative complications.
Traditional acupuncture has been shown to improve cerebral micro-circulation, correct energy metabolism disorders, alleviate chronic pain and regulate visceral function, lessen fatigue and modulate immune. Moreover, acupuncture is a simple, effective and safe therapy. Electroacupuncture therapy is produced and developed on the basis of acupuncture therapy, which has a regulatory effect on multiple systems of the body and can play a regulatory effect that is consistent with normal physiological regulation. Modern medicine believes that the anterior cingulate gyrus, hippocampus, and other regions of the limbic system are the possible center control of emotion and cognition. Electroacupuncture treatment can help accelerate the recovery of central nervous system function, which plays a protective role on the central nerve system, especially the brain, within 24-72 hours after electroacupuncture treatment. At the same time, electroacupuncture is beneficial to the recovery of immune function postoperatively, it can promote the release of central neurotransmitters and improve receptor activity, so as to play a role in postoperative analgesia, reduce the dosage of anesthetics, brain protection, neurological function rehabilitation, and so on. According to scientific research, it also posses a certain effect on the prevention and treatment of postoperative delirium. Sevoflurane is an inhale anesthetic which is widely used in clinics for pediatric general anesthesia. Due to the high incidence of postoperative delirium and agitation, it has been given rise to great concern on pediatric clinical anesthesia. In order to reduce delirium and agitation incidence, the investigators apply electroacupuncture in pediatric for sevoflurane combined with intravenous general anesthesia, aim to target a safe way to lessen postoperative brain complications on pediatric.
This is a single-center experimental study that employs randomization, triple-blinding, and control study. Pediatric patients were randomly assigned to two groups, sevoflurane general anesthesia group (S group) and electroacupuncture group (E group), 40 patients, respectively. Anesthesia induction, maintenance, and monitoring be performed identically in both groups, the S group will not receive electroacupuncture treatment, the E group will receive electroacupuncture therapy. Electroacupuncture intervention will be performed by blinded acupuncture physicians, visitor who is blind to collect preoperative, intraoperative and postoperative data while visiting patients, data statisticians, who are blind to the intervention, data collection, conducted statistical analyses on the data electronically.
Read the detailed description
Pediatric patients who meet the screening criteria were randomly divided into two groups,sevoflurane general anesthesia group (S group) and electroacupuncture group (E group), 40 patients in each group, respectively. Anesthesia induction, maintenance, and monitoring performed identically in both groups, the S group will not receive electroacupuncture treatment, the E group will receive electroacupuncture therapy. All patients have a regular preoperative fasting, monitoring of vital signs after the patient was admitted to the operating room, Preoxygenation was performed by face mask oxygen with oxygen flow set to 8 L/min for 3 minutes to each patient, and anesthesia induced with 8% sevoflurane inhalation while oxygen flow rate will set to 2 L/min. After the patient slept and accessing successful venipuncture, intravenous drugs were administered with midazoline 0.03-0.05 mg/kg, propofol 0.3-0.5 mg/kg, sufentanil 0.4-0. 5 mg/ kg, and cisatracurium 0.15 mg/kg for induction of anesthesia. After the patient's muscle relaxation, tracheal intubation was performed, and the patient's airway pressure was monitored by connecting an airway pressure detection device, and then IPPV-controlled ventilation was performed by connecting a Drager Fabius GS anesthesia machine (Drager Germany), with oxygen flow rate set to 1 L/min, initial tidal volume set to 6-8 ml/kg, and initial respiratory rate set to 15-20 bpm, adjusted to PaCO2 was maintained at about 36-40 mmHg. The patient's depth of anesthesia was also detected with the EEG dual frequency index, and the BIS was about 45-50.
After general anesthesia induction, the acupuncturist used a Huatuo brand copper milli-needle (Suzhou Medical Supplies Factory) and selected Baihui point（DU20）, Shenting point (DU24), bilateral Zulinqi (GB41) and bilateral Taichong (LR3) point, for acupuncture. The acupuncture points are located 5 inches straight up from the middle of the front hairline of the head, and 0.3-0.5 inches from the midpoint of the front and back hairline of the patient's head in a 1-inch deviation. The TaiChong (LR3) point is located on the back of the patient's foot between the 1st and 2nd metatarsal bones, in the depression in front of the union of the metatarsal bones, or when the patient's foot artery is pulsating, the point is taken from the patient's 1st and 2nd metatarsal bones and pushed backward to the bottom, with a vertical puncture of 0.5-0.8 inch; the foot Linobu (GB41) point is located on the back of the patient's foot, in front of the union of the 4th and 5th metatarsal bones, on the outside of the 5th toe extensor tendon, with a vertical stab of 0.3-0.5 inch.
Then,the acupuncturist check the EA device ( SDZ-Ⅱ,Suzhou Medical Supplies Factory)before use, the EA device is set to zero at the beginning, then connect the acupuncture needle to the EA device and fixed, output frequency of EA from weak to strong (50-100hz) ,use sparse and dense mode,after 20 minutes intervention, pause the EA output, turn off the electric power ,and pulled out the needle. all the acupoint pressed by the Cotton swabs until there is no bleeding.
Maintenance of anesthesia: Patients were given continuous intraoperative inhalation of 1% sevoflurane combined with continuous intravenous propofol 5 mg.kg-1h-1 sevoflurane inhalation will be discontinued 30 minutes before the end of surgery, and propofol was stopped immediately after surgery. The inhalation concentration of sevoflurane adjusting according to the depth of anesthesia, intermittent intraoperative injection of sufentanil and cisatracurium, and other anesthetic drugs stopped at the end of surgery. All the pediatric anesthesia will be carried out by the anesthesiologists. Intraoperative BP, HR, MAP, RR, SpO2, infusion fluid and bleeding volume, total anesthetic dosage all keep record in time by the anesthesiologists. The anesthesia depth measures by Bispro (BeliveA2) and maintains between 40-60.
All patients are transferred to the PACU at the end of surgery, the patient's ECG, HR, MAP, RR, and SpO2 are monitored all the time. The tracheal tube is removed after the patient was fully awake, and recovery and extubation time keeps in record, PAED scale, Wong-bank facial expression scale, Ramsay sedation score recorded, adverse events of anesthesia like nausea, and vomiting all recorded 2 hours, 24 hours, 72 hours postoperatively; as well as anal exhaust time and defecate time. Venous blood sampling for inflammatory factors is carried out preoperative, 24 hours and 72 hours postoperatively.
In this experiment, the blinded investigator (acupuncturist) will perform the electroacupuncture intervention on the patients, the blinded investigator (assess visitor) will collect the data, and the blinded data statistician will analyze the data by computer and perform the statistical analysis. It will be performed using SPSS 17.0 statistical analysis software. All statistical tests were performed using a two-sided test, and a p-value less than or equal to 0.05 was considered a statistically significant difference.
- Being tested
- electroacupuncture
- Keywords
- Electroacupuncture, Sevoflurane, Postoperative agitation, pediatrics
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
Electroacupuncture (EA) is a method of treating diseases by inserting a needle (usually a filiform needle) into the skin or tissue of a patient at a certain Angle, and then passing through the needle (sensing) micro-current waves of human bioelectricity to stimulate specific parts of the human body (acupoints). Equipment used in the trial included:
- Huatuo brand copper filiform needle (diameter: 0.35×50mm), Suzhou Medical Supplies Factory, Food and Drug Administration firearms production: Suzhou Food and Drug Administration firearms production No. 20010020.
- Electroacupuncture apparatus: SDZ-Ⅱ electroacupuncture apparatus of Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Registration No. : 20172270675
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group (E group) | Experimental | When the patient's vital signs are stable, the blind researcher (acupuncturist) checks the electroacupuncture device, (SDZ-Ⅱ, Suzhou Medical Supplies Factory),after the check is been done, acupuncturist uses Huatuo brand copper milli-needle needles to pierce Baihui point（DU20）, Shenting point (DU24), bilateral Zulinqi (GB41) and bilateral Taichong (LR3) , and fixed and connection them to SDZ-Ⅱ..At first, sets the device output to zero ,then .the acupuncturist turns on the power of the treatment instrument with the output frequency from 50 to 100hz on a weak to strong wave mode continuously , 20 min after the intervention, stops the machine, the acupuncturist turns off the device and pulls out the needles. Receives: Other: electroacupuncture |
| sevoflurane general anesthesia group（S group） | No intervention | Anesthesia induction, anesthesia maintenance and anesthesia monitoring will carry out exactly the same in both groups,only difference is that S group has no electroacupuncture intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium Scale
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Measured: 24 hours before surgery,
Pediatric Anesthesia Emergence Delirium Scale
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Measured: 2 hours after extubation in PACU
Pediatric Anesthesia Emergence Delirium Scale
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Measured: 24 hours after surgery
Pediatric Anesthesia Emergence Delirium Scale
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Measured: 72 hours after surgery
Secondary outcomes (4)
Wong-bank(FPS-R)
FPS-R asks participants to rate their global pain level on a scale of 0 (no pain) to 10 (worst pain). Fp- R provides cartoon images of six facial expressions (ranging from smiling to sad to painful crying) to represent the pain level. For the assessment, the patient points to a scale or cartoon face that corresponds to his or her pain level
Measured: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.
visual analogue scale (VAS)
Visual analogue Scale (VAS) is the most commonly used single-dimensional measurement of pain intensity. The scale mainly consists of a 10-cm straight line, one end of which indicates "no pain at all" and the other end indicates "the most severe pain imaginable" or "pain to the extreme" etc. The patient is asked to mark the corresponding position on the line (with a dot or a "✕" etc.) to indicate the intensity of the pain they feel at the time.
Measured: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery
Inflammatory markers in venous blood
The following indexes were observed: IL-6, IL-8, CPR, S-100β, NSE, SOD, TNF-α.
Measured: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.
Sequencing analysis of the gut microbiota
The human gut is home to a large number of microorganisms, also a place for absorption, energy metabolism, immune regulation, and many disease.By observing the time of nausea, vomiting, anal exhaust and defecation (and collecting feces)time,, This is the first time to explore whehter gut flora plays an important role on peadatric agitation postoperatively. The study of intestinal flora is of great significance on peadatric agitation undergoing sevoflurane general anesthesia with the electroacupuncture intervention .
Measured: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetics ToxicityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization according to center will be used. Subjects were randomly assigned to the sevoflurane general anesthesia group（S group） and the electroacupuncture group（E group） at a ratio of 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leihuajuan, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Investigators
- Feng Zhong, Doctor, Principal investigator, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924854
- Sponsor's protocol ID
- 2019XJJJ040
- Acronym
- DZDXEQFWQMSHZD
- Status last verified
- Sep 2023
- First submitted
- 30 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Describe the IPD sharing plan, including what IPD are to be shared with other researchers：
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Electroacupuncture on Postoperative Agitation of Sevoflurane Inhalation Combined With Intravenous Anesthesia in Pediatrics: an Experimental, Single-center Clinical Study
- ClinicalTrials.gov ID
- NCT05924854
- Acronym / sponsor ID
- DZDXEQFWQMSHZD / 2019XJJJ040
- Keywords
- Electroacupuncture, Sevoflurane, Postoperative agitation, pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Jun 2023 (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.
Postoperative agitation is a common complication in pediatric anesthesia, with an incidence ranging from 10% to 80%. Common surgical procedures in children include tonsillectomy, adenoidectomy, insidious penis prolongation and circumcision, etc. Postoperative delirium and agitation is a clinical emergency, and can have detrimental effects on the child's health. The primary clinical manifestations include disorganized movements, moaning, incoherent speech, confusion and paranoid characters, inability to be concentrated, and irritability, obstinacy or uncooperative; all these would increase the risks of falling out of bed, possible fractures, and all kinds of tube loss. These symptoms would sustain postoperative recovery significantly and pose a possible long-term neurological dysfunction. As a result, an extended hospitalization, elevated in-hospital mortality rate, escalated medical expenses, heightened risk of cognitive impairment, reduced quality of life, and increased incidence of postoperative complications.
Traditional acupuncture has been shown to improve cerebral micro-circulation, correct energy metabolism disorders, alleviate chronic pain and regulate visceral function, lessen fatigue and modulate immune. Moreover, acupuncture is a simple, effective and safe therapy. Electroacupuncture therapy is produced and developed on the basis of acupuncture therapy, which has a regulatory effect on multiple systems of the body and can play a regulatory effect that is consistent with normal physiological regulation. Modern medicine believes that the anterior cingulate gyrus, hippocampus, and other regions of the limbic system are the possible center control of emotion and cognition. Electroacupuncture treatment can help accelerate the recovery of central nervous system function, which plays a protective role on the central nerve system, especially the brain, within 24-72 hours after electroacupuncture treatment. At the same time, electroacupuncture is beneficial to the recovery of immune function postoperatively, it can promote the release of central neurotransmitters and improve receptor activity, so as to play a role in postoperative analgesia, reduce the dosage of anesthetics, brain protection, neurological function rehabilitation, and so on. According to scientific research, it also posses a certain effect on the prevention and treatment of postoperative delirium. Sevoflurane is an inhale anesthetic which is widely used in clinics for pediatric general anesthesia. Due to the high incidence of postoperative delirium and agitation, it has been given rise to great concern on pediatric clinical anesthesia. In order to reduce delirium and agitation incidence, the investigators apply electroacupuncture in pediatric for sevoflurane combined with intravenous general anesthesia, aim to target a safe way to lessen postoperative brain complications on pediatric.
This is a single-center experimental study that employs randomization, triple-blinding, and control study. Pediatric patients were randomly assigned to two groups, sevoflurane general anesthesia group (S group) and electroacupuncture group (E group), 40 patients, respectively. Anesthesia induction, maintenance, and monitoring be performed identically in both groups, the S group will not receive electroacupuncture treatment, the E group will receive electroacupuncture therapy. Electroacupuncture intervention will be performed by blinded acupuncture physicians, visitor who is blind to collect preoperative, intraoperative and postoperative data while visiting patients, data statisticians, who are blind to the intervention, data collection, conducted statistical analyses on the data electronically.
Detailed description
Pediatric patients who meet the screening criteria were randomly divided into two groups,sevoflurane general anesthesia group (S group) and electroacupuncture group (E group), 40 patients in each group, respectively. Anesthesia induction, maintenance, and monitoring performed identically in both groups, the S group will not receive electroacupuncture treatment, the E group will receive electroacupuncture therapy. All patients have a regular preoperative fasting, monitoring of vital signs after the patient was admitted to the operating room, Preoxygenation was performed by face mask oxygen with oxygen flow set to 8 L/min for 3 minutes to each patient, and anesthesia induced with 8% sevoflurane inhalation while oxygen flow rate will set to 2 L/min. After the patient slept and accessing successful venipuncture, intravenous drugs were administered with midazoline 0.03-0.05 mg/kg, propofol 0.3-0.5 mg/kg, sufentanil 0.4-0. 5 mg/ kg, and cisatracurium 0.15 mg/kg for induction of anesthesia. After the patient's muscle relaxation, tracheal intubation was performed, and the patient's airway pressure was monitored by connecting an airway pressure detection device, and then IPPV-controlled ventilation was performed by connecting a Drager Fabius GS anesthesia machine (Drager Germany), with oxygen flow rate set to 1 L/min, initial tidal volume set to 6-8 ml/kg, and initial respiratory rate set to 15-20 bpm, adjusted to PaCO2 was maintained at about 36-40 mmHg. The patient's depth of anesthesia was also detected with the EEG dual frequency index, and the BIS was about 45-50.
After general anesthesia induction, the acupuncturist used a Huatuo brand copper milli-needle (Suzhou Medical Supplies Factory) and selected Baihui point（DU20）, Shenting point (DU24), bilateral Zulinqi (GB41) and bilateral Taichong (LR3) point, for acupuncture. The acupuncture points are located 5 inches straight up from the middle of the front hairline of the head, and 0.3-0.5 inches from the midpoint of the front and back hairline of the patient's head in a 1-inch deviation. The TaiChong (LR3) point is located on the back of the patient's foot between the 1st and 2nd metatarsal bones, in the depression in front of the union of the metatarsal bones, or when the patient's foot artery is pulsating, the point is taken from the patient's 1st and 2nd metatarsal bones and pushed backward to the bottom, with a vertical puncture of 0.5-0.8 inch; the foot Linobu (GB41) point is located on the back of the patient's foot, in front of the union of the 4th and 5th metatarsal bones, on the outside of the 5th toe extensor tendon, with a vertical stab of 0.3-0.5 inch.
Then,the acupuncturist check the EA device ( SDZ-Ⅱ,Suzhou Medical Supplies Factory)before use, the EA device is set to zero at the beginning, then connect the acupuncture needle to the EA device and fixed, output frequency of EA from weak to strong (50-100hz) ,use sparse and dense mode,after 20 minutes intervention, pause the EA output, turn off the electric power ,and pulled out the needle. all the acupoint pressed by the Cotton swabs until there is no bleeding.
Maintenance of anesthesia: Patients were given continuous intraoperative inhalation of 1% sevoflurane combined with continuous intravenous propofol 5 mg.kg-1h-1 sevoflurane inhalation will be discontinued 30 minutes before the end of surgery, and propofol was stopped immediately after surgery. The inhalation concentration of sevoflurane adjusting according to the depth of anesthesia, intermittent intraoperative injection of sufentanil and cisatracurium, and other anesthetic drugs stopped at the end of surgery. All the pediatric anesthesia will be carried out by the anesthesiologists. Intraoperative BP, HR, MAP, RR, SpO2, infusion fluid and bleeding volume, total anesthetic dosage all keep record in time by the anesthesiologists. The anesthesia depth measures by Bispro (BeliveA2) and maintains between 40-60.
All patients are transferred to the PACU at the end of surgery, the patient's ECG, HR, MAP, RR, and SpO2 are monitored all the time. The tracheal tube is removed after the patient was fully awake, and recovery and extubation time keeps in record, PAED scale, Wong-bank facial expression scale, Ramsay sedation score recorded, adverse events of anesthesia like nausea, and vomiting all recorded 2 hours, 24 hours, 72 hours postoperatively; as well as anal exhaust time and defecate time. Venous blood sampling for inflammatory factors is carried out preoperative, 24 hours and 72 hours postoperatively.
In this experiment, the blinded investigator (acupuncturist) will perform the electroacupuncture intervention on the patients, the blinded investigator (assess visitor) will collect the data, and the blinded data statistician will analyze the data by computer and perform the statistical analysis. It will be performed using SPSS 17.0 statistical analysis software. All statistical tests were performed using a two-sided test, and a p-value less than or equal to 0.05 was considered a statistically significant difference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization according to center will be used. Subjects were randomly assigned to the sevoflurane general anesthesia group（S group） and the electroacupuncture group（E group） at a ratio of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group (E group) | Experimental | Other: electroacupunctureWhen the patient's vital signs are stable, the blind researcher (acupuncturist) checks the electroacupuncture device, (SDZ-Ⅱ, Suzhou Medical Supplies Factory),after the check is been done, acupuncturist uses Huatuo brand copper milli-needle needles to pierce Baihui point（DU20）, Shenting point (DU24), bilateral Zulinqi (GB41) and bilateral Taichong (LR3) , and fixed and connection them to SDZ-Ⅱ..At first, sets the device output to zero ,then .the acupuncturist turns on the power of the treatment instrument with the output frequency from 50 to 100hz on a weak to strong wave mode continuously , 20 min after the intervention, stops the machine, the acupuncturist turns off the device and pulls out the needles. |
| sevoflurane general anesthesia group（S group） | No intervention | –Anesthesia induction, anesthesia maintenance and anesthesia monitoring will carry out exactly the same in both groups,only difference is that S group has no electroacupuncture intervention. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 4-13 years old, both sexes;
- Tonsillectomy, adenoidectomy, concealed penis, and circumcision were planned under sevoflurane intravenous inhalation combined general anesthesia;
- The weight of the children was 10-60kg;
- The child had no history of allergy or mental disease.
- No respiratory tract infection within two weeks;
Key exclusion criteria (10 listed)
- Age < 4 years old, age > 13 years old;
- Body weight < 10kg, body weight > 60kg;
- The child has a history of heart disease, asthma, mental disease, and major surgery;
- A history of respiratory infection in the past two weeks;
- Non-electroacupuncture indications;
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 |
|---|---|---|
| electroacupunctureElectroacupuncture (EA) is a method of treating diseases by inserting a needle (usually a filiform needle) into the skin or tissue of a patient at a certain Angle, and then passing through the needle (sensing) micro-current waves of human bioelectricity to stimulate specific parts of the human body (acupoints). Equipment used in the trial included: 1. Huatuo brand copper filiform needle (diameter: 0.35×50mm), Suzhou Medical Supplies Factory, Food and Drug Administration firearms production: Suzhou Food and Drug Administration firearms production No. 20010020. 2. Electroacupuncture apparatus: SDZ-Ⅱ electroacupuncture apparatus of Huatuo brand, Suzhou Medical Supplies Factory Co., LTD., Registration No. : 20172270675 | Other | Electroacupuncture group (E group) |
Primary outcome
Pediatric Anesthesia Emergence Delirium Scale
Time frame: 24 hours before surgery,
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Pediatric Anesthesia Emergence Delirium Scale
Time frame: 2 hours after extubation in PACU
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Pediatric Anesthesia Emergence Delirium Scale
Time frame: 24 hours after surgery
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
Pediatric Anesthesia Emergence Delirium Scale
Time frame: 72 hours after surgery
PAED is one of the commonly used scales in clinical practice. The scale includes 5 items, and the scores of each item are summed to obtain the PAED score. The higher the score, the more severe the degree of delirium.
4 secondary outcomes
Wong-bank(FPS-R)
Time frame: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.
visual analogue scale (VAS)
Time frame: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery
Inflammatory markers in venous blood
Time frame: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.
Sequencing analysis of the gut microbiota
Time frame: 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No. Describe the IPD sharing plan, including what IPD are to be shared with other researchers：
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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.
Feng Zhong, Doctor principal investigator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with General Anesthetics Toxicity and Postoperative Cognitive Dysfunction, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine 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 8 inclusion and 10 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 21 Sep 2023. 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. 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?
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?
Pediatric Anesthesia Emergence Delirium Scale (time frame: 24 hours before surgery,). The study lists 4 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 21 Sep 2023.