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

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

Interventions

OTHER

electroacupuncture

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

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Feng Zhong, Doctor · Hunan University of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2023-12-01

Completion

2024-06-30

Countries

• China

Study Locations