Postoperative Fatigue Syndrome
Conditions
Interventions
Test group:Perioperative administration of Yangwei Jianpi Ointment
Control group:Perioperative administration of placebo ointment
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine (Dade Road Main Branch)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 65 years, male or female; 2) American Society of Anesthesiologists (ASA) Physical Status Classification I–III; 3) Scheduled to undergo elective endoscopic surgery under general anesthesia with endotracheal intubation, including gastrointestinal, hepatobiliary and pancreatic, thoracic, gynecological, and urological surgeries; 4) Preoperative traditional Chinese medicine constitution assessment meets the diagnostic criteria for spleen Qi deficiency syndrome according to the Expert Consensus on Diagnosis and Treatment of Spleen Deficiency Syndrome in Traditional Chinese Medicine (2023): The primary symptoms include 1) fatigue and reluctance to speak, 2) loose stools, and 3) poor appetite. The secondary symptoms include 1) postprandial abdominal distension, 2) dull abdominal pain triggered by exertion, 3) tastelessness in the mouth, 4) sallow complexion, and 5) weak defecation. Tongue presentation: pale tongue with possible tooth marks, thin white coating. Pulse presentation: weak and lack of strength. Diagnosis can be made with the presence of 2 primary symptoms and 2 secondary symptoms along with tongue and pulse findings, or with 1 primary symptom and 3 secondary symptoms along with tongue and pulse findings; 5) Expected duration of surgery =1 hour; 6) Understand the content of this study, be able to cooperate in completing the assessment scales, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Preoperative diagnosis of fatigue syndrome (Visual Analog Scale score >5); preoperative TCM syndrome differentiation indicating spleen Yin deficiency syndrome (e.g., significant dry mouth, red tongue with scant coating) and internal dampness-heat syndrome (e.g., yellow greasy tongue coating, bitter taste in the mouth); patients with spleen deficiency complicated by other major pathogenic factors (such as phlegm-dampness); 2) Severe cardiac, pulmonary, hepatic, or renal dysfunction (e.g., NYHA Class III–IV, Child-Pugh Class C, eGFR 6 hours or postoperative requirement for ICU admission; 6) Known allergy to any component of Yangwei Jianpi Ointment; 7) History of psychiatric or psychological disorders, chronic pain; preoperative use of nonsteroidal anti-inflammatory drugs (NSAIDs) or opioid analgesics, glucocorticoids, immunosuppressants, central nervous system stimulants or depressants, or other Chinese herbal preparations with definite effects of "supplementing Qi and strengthening the spleen"; 8) Body mass index (BMI) >30 kg/m²; 9) Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative fatigue syndrome on postoperative day 7; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of POF on postoperative days 1, 3, 5, and 14;Fatigue severity;Postoperative recovery quality; | — |
Countries
China
Contacts
Public ContactZhao Gaofeng
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed