Application of Multimodal Intervention in the Prevention of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery

1. Background Postoperative nausea and vomiting (PONV) is a common complication aftergeneral anesthesia, with an incidence as high as 80% in gynecological laparoscopicsurgery. Transcutaneous electrical acupoint stimulation (TEAS) has shown potentialas a non‐invasive, side‐effect‐free intervention. Combining pharmacological agents(dexamethasone or amisulpride) with TEAS may provide a synergistic preventiveeffect, aligning with enhanced recovery after surgery (ERAS) principles. 2. Study Objectives To evaluate the preventive effect of TEAS on PONV in patientsundergoing gynecological laparoscopic surgery, compared with sham stimulation.To explore the synergistic effect of dexamethasone or amisulpride when combined withTEAS, and to optimize PONV prevention strategies.To assess the impact of multimodal intervention on postoperative recovery quality,length of hospital stay, and patient satisfaction.To evaluate the safety of the combined interventions and record any adverse events. 3. Study Design Design type: 2×2 factorial, randomized, double‐blind (participants,outcome assessors, and data analysts blinded to group assignment).Randomization: 1:1:1:1 allocation using an online randomization tool.3.1 Study Groups Group Intervention A TEAS + Dexamethasone B TEAS + Amisulpride CSham stimulation + Dexamethasone D Sham stimulation + Amisulpride 3.2 ParticipantsInclusion criteria: Age 18‐65 years; ASA physical status I‐II; scheduled forelective gynecological laparoscopic surgery (e.g., ovarian cystectomy, myomectomy)under general anesthesia; willing to provide informed consent.Exclusion criteria: Severe cardiac, hepatic, renal, or pulmonary disease; allergy orskin disease at TEAS application site; Receipt of antiemetics within 24 h beforesurgery; Implanted cardiac pacemaker, cardioverter‐;pregnancy or lactation;vulnerable populations (e.g., critically ill, psychiatric disorders, cognitiveimpairment, illiteracy); any condition deemed unsuitable by the investigator.3.3 Interventions A wearable transcutaneous electrical acupoint stimulation (TEAS)wristband will be applied to the P6 (Neiguan) acupoint on the dominant upperextremity. The P6 acupoint is located approximately 3‐5 cm proximal to the distalwrist crease, between the tendons of the flexor carpi radialis and palmaris longus.The device integrates the stimulating electrodes within the wristband and does notrequire external adhesive electrodes.TEAS or sham stimulation will be administered at three time points: 30 minutesbefore surgery and 24 and 48 hours after surgery, with each session lasting 30minutes.Dexamethasone 5 mg (off‐label for PONV; approved for inflammatory/allergicconditions).Amisulpride 5 mg.3.4 Outcome MeasuresPrimary outcomes (0‐48 h postoperatively):PONV incidence (proportion of patients with nausea, vomiting, or retching). PONVseverity (0 = none, 1 = nausea only, 2 = vomiting/retching, 3 = refractorynausea/vomiting).Secondary outcomes:Recovery quality: time to first flatus, first ambulation, hospital stay, bowelfunction recovery.Patient satisfaction: Visual Analogue Scale (VAS, 0‐10) and QoR‐15 score (0‐150).Rescue antiemetic use. Management needs for severe PONV. Postoperative pain (VAS atrest and on movement) and opioid consumption. Device‐related adverse events (skinirritation, burning, allergy). Drug‐related adverse events (e.g., hyperglycemia,hypotension, headache, dizziness, QT prolongation).Intraoperative hemodynamics and postoperative complications (e.g., infection,shivering, urinary retention).3.5 Follow‐up Schedule Postoperative day 1 (24 h): PONV assessment, time to firstflatus and ambulation.Postoperative day 2 (48 h): PONV incidence/severity, rescue medication. Atdischarge: Satisfaction, hospital stay (via in‐person or telephone follow‐up). 4. Sample Size Calculation Assumptions: PONV incidence 50% in control groups, 30% inTEAS groups; two‐sided α = 0.05; power = 80%.Each main effect level requires 93 patients. For a 2×2 factorial design with1:1:1:1 allocation, this translates to 47 patients per group (total 188). Accountingfor a 10% dropout rate, final sample size = 212 patients (53 per group). 5. Data Management and Confidentiality Electronic Data Capture (EDC) system with uniquecoding (no direct identifiers).Access restricted to authorized research team members. 6. Informed Consent Written informed consent will be obtained from each participantafter full explanation of the study purpose, procedures, risks, and benefits.Participants are informed of their right to withdraw at any time. 7. Adverse Event Management Dexamethasone‐related AEs (transient hyperglycemia, bloodpressure fluctuation, gastrointestinal discomfort, rare allergic reactions).Amisulpride‐related AEs (headache, dizziness, constipation/diarrhea, QT prolongation,allergic reactions).TEA‐related AEs (local skin discomfort, redness, itching, rare blisters or mild burns).