Postoperative nausea and vomiting
Conditions
Interventions
Experimental group (Yangwei Decoction group):The experimental group adopted the principle of syndrome differentiation and treatment, selecting patients suitable for this syndrome type (spleen-stomach
Control group (placebo group):Select patients with the same syndrome type as the experimental group, administer an equal amount of placebo, once daily, divided into two doses in the morning and evenin
Sponsors
Kunming Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Patients who meet the diagnostic criteria for mixed hemorrhoids in the "Clinical Guidelines for the Diagnosis and Treatment of Hemorrhoids (2020 Edition)" and are scheduled for elective external stripping and internal ligation for mixed hemorrhoids under combined spinal-epidural anesthesia; Patients who meet the high-risk criteria for postoperative nausea and vomiting (PONV) in the "Guidelines for the Diagnosis and Treatment of Postoperative Nausea and Vomiting (2025 Edition)", i.e., having =2 of the following high-risk factors: female gender, age 18-50 years, postoperative use of opioid analgesics, non-smoking, history of motion sickness/previous PONV history; Patients with American Society of Anesthesiologists (ASA) physical status classification I-II; Patients whose traditional Chinese medicine (TCM) pattern identification conforms to the criteria of spleen-stomach deficiency and dampness obstruction, with identification standards developed based on the "Diagnostic Criteria for TCM Diseases and Syndromes and Efficacy Assessment" and the "Guidelines for Clinical Research of New TCM Drugs": Main symptoms: poor appetite, abdominal distension, fatigue; Secondary symptoms: limb weariness, loose stools, belching with acid regurgitation; Tongue and pulse: pale red tongue with white greasy/white slippery coating, deep slow/ pulse; Pattern identification criteria: presence of 2 main symptoms + 1 secondary symptom, combined with tongue and pulse findings, is sufficient for identification; Voluntary participation in this study, signed informed consent, good compliance, and ability to cooperate with follow-up; No use of antiemetics, prokinetic agents, glucocorticoids, or opioids within 1 week prior to surgery, and no active gastrointestinal diseases affecting gastrointestinal function.
Exclusion criteria
Exclusion criteria: Subjects with TCM syndrome differentiation, tongue appearance, and pulse findings not consistent with spleen-stomach deficiency and dampness obstruction syndrome; Subjects with severe diseases of major organs such as heart, liver, lung, or kidney (liver function: ALT/AST exceeding upper normal limit by 2 times, renal function: serum creatinine exceeding upper normal limit by 1.5 times, cardiac function: NYHA = Class III); Subjects with preoperative conditions such as gastroesophageal reflux disease, chronic gastritis, or intestinal obstruction that may cause nausea and vomiting; Subjects who have used antiemetic drugs, prokinetic agents, hormones, or opioid drugs within 1 week prior to surgery; Subjects with mental disorders or cognitive impairments unable to cooperate, pregnant or breastfeeding women, or those allergic to the herbal components of this study; Subjects who have participated in other clinical trials within 3 months prior to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of postoperative nausea and vomiting within 72 hours post-operation;The severity and characteristics of postoperative nausea and vomiting;Gastrointestinal Function Objective Indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| pain-related index;Analgesia-related indicators;Pain-related complications;Anxiety and Psychological Comfort Index;Postoperative Sleep Quality;Indicators related to gastrointestinal function recovery;Abdominal distension-related indicators;Gastrointestinal function-related complications;Specialized indicators in proctology;Anesthesia-related indicators;Rehabilitation and Prognosis Related Indicators;Traditional Chinese Medicine (TCM) Syndrome Efficacy;Laboratory Routine Indicators;Safety Evaluation Criteria; | — |
Countries
China
Contacts
Public ContactNing Tao
Kunming Traditional Chinese Medicine Hospital
Outcome results
None listed