The Influence of Electroacupuncture on Postoperative Agitation of Pediatrics Undergoing Sevoflurane General Anesthesia

NCT05924854 | Unknown

• 1 other identifier: 2019XJJJ040
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

General Anesthetics Toxicity; Postoperative Cognitive Dysfunction; Electroacupuncture

Keywords

Electroacupuncture; Sevoflurane; Postoperative agitation; pediatrics

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  72 hours after surgery

Secondary Outcomes (4)

• Wong-bank(FPS-R)

  24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.

• visual analogue scale (VAS)

  24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery

• Inflammatory markers in venous blood

  24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.

• Sequencing analysis of the gut microbiota

  24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery.

Other Outcomes (1)

• The wake recovery time of the patient after the operation

  the patient is transfer to the pacu and observe 2 hours after the extubation.

Study Arms (2)

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.

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.

Interventions

electroacupuncture OTHER

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: 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

Electroacupuncture group (E group)

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410007, China

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Feng Zhong, Doctor

  Hunan University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the particularity of acupuncture research, acupuncturist only carries out electroacupuncture. Blinded evaluation visitor will be used in the trial, and the efficacy will be evaluated by a third party not envovled in assignments. Blind statistical analysis was used in the data summary stage, and the researchers, operators and statisticians were separated to ensure the authenticity and reliability of the study results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 29, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)