Postoperative Cognitive Dysfunction Clinical Trial
— DZDXEQFWQMSHZDOfficial 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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 13 Years |
Eligibility | Inclusion Criteria: 1. Age 4-13 years old, both sexes; 2. Tonsillectomy, adenoidectomy, concealed penis, and circumcision were planned under sevoflurane intravenous inhalation combined general anesthesia; 3. The weight of the children was 10-60kg; 4. The child had no history of allergy or mental disease. 5. No respiratory tract infection within two weeks; 6. No infection at the puncture site; 7. 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). 8. The informed consent was signed by the legal guardian of the patient before surgery. Exclusion Criteria: 1. Age < 4 years old, age > 13 years old; 2. Body weight < 10kg, body weight > 60kg; 3. The child has a history of heart disease, asthma, mental disease, and major surgery; 4. A history of respiratory infection in the past two weeks; 5. Non-electroacupuncture indications; 6. Infection at the acupuncture site; 7. Patients with liver and kidney insufficiency, cardiopulmonary insufficiency; 8. Those with allergic constitution (allergic to two or more substances); 9. Persons with legal disabilities; 10. Refusal to sign the consent form; |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Hunan University of Chinese Medicine | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The wake recovery time of the patient after the operation | The wake recovery time of the patient after the operation (the patient is transfer to the pacu and observe 2 hours after the extubation ). | the patient is transfer to the pacu and observe 2 hours after the extubation. | |
Primary | 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, | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery. | |
Secondary | 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. | 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery | |
Secondary | Inflammatory markers in venous blood | The following indexes were observed: IL-6, IL-8, CPR, S-100ß, NSE, SOD, TNF-a. | 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery. | |
Secondary | 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 . | 24 hours before surgery, 2 hours after extubation in PACU, and 24 hours and 72 hours after surgery. |
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