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

Официальное название

Transcutaneous Electrical Acupoint Stimulation Versus Sham Stimulation Combined With Dexamethasone Versus Amisulpride for Preventing Postoperative Nausea and Vomiting After Laparoscopic Gynecological Surgery: A Randomized Controlled Factorial Trial

Обзор

1. Background Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia, with an incidence as high as 80% in gynecological laparoscopic surgery. Transcutaneous electrical acupoint stimulation (TEAS) has shown potential as a non-invasive, side-effect-free intervention. Combining pharmacological agents (dexamethasone or amisulpride) with TEAS may provide a synergistic preventive effect, aligning with enhanced recovery after surgery (ERAS) principles. 2. Study Objectives To evaluate the preventive effect of TEAS on PONV in patients undergoing gynecological laparoscopic surgery, compared with sham stimulation. To explore the synergistic effect of dexamethasone or amisulpride when combined with TEAS, 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 C Sham stimulation + Dexamethasone D Sham stimulation + Amisulpride 3.2 Participants Inclusion criteria: Age 18-65 years; ASA physical status I-II; scheduled for elective 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 or skin disease at TEAS application site; Receipt of antiemetics within 24 h before surgery; Implanted cardiac pacemaker, cardioverter-;pregnancy or lactation; vulnerable populations (e.g., critically ill, psychiatric disorders, cognitive impairment, 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 upper extremity. The P6 acupoint is located approximately 3-5 cm proximal to the distal wrist crease, between the tendons of the flexor carpi radialis and palmaris longus. The device integrates the stimulating electrodes within the wristband and does not require external adhesive electrodes. TEAS or sham stimulation will be administered at three time points: 30 minutes before surgery and 24 and 48 hours after surgery, with each session lasting 30 minutes. Dexamethasone 5 mg (off-label for PONV; approved for inflammatory/allergic conditions). Amisulpride 5 mg. 3.4 Outcome Measures Primary outcomes (0-48 h postoperatively): PONV incidence (proportion of patients with nausea, vomiting, or retching). PONV severity (0 = none, 1 = nausea only, 2 = vomiting/retching, 3 = refractory nausea/vomiting). Secondary outcomes: Recovery quality: time to first flatus, first ambulation, hospital stay, bowel function 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 at rest and on movement) and opioid consumption. Device-related adverse events (skin irritation, 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 first flatus and ambulation. Postoperative day 2 (48 h): PONV incidence/severity, rescue medication. At discharge: Satisfaction, hospital stay (via in-person or telephone follow-up). 4. Sample Size Calculation Assumptions: PONV incidence 50% in control groups, 30% in TEAS groups; two-sided α = 0.05; power = 80%. Each main effect level requires \~93 patients. For a 2×2 factorial design with 1:1:1:1 allocation, this translates to 47 patients per group (total 188). Accounting for a 10% dropout rate, final sample size = 212 patients (53 per group). 5. Data Management and Confidentiality Electronic Data Capture (EDC) system with unique coding (no direct identifiers). Access restricted to authorized research team members. 6. Informed Consent Written informed consent will be obtained from each participant after 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, blood pressure 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).

Вмешательства

• Препарат Amisulpride Injection
  Amisulpride：Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.
• Препарат Dexamethasone (intravenous)
  Dexamethasone: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.
• Устройство Transcutaneous electrical acupoint stimulation (TEAS)
  Applied at the P6 acupoint (located on the inner forearm, approximately 2 cun proximal to the wrist crease) using a transcutaneous electrical stimulator. Stimulation is delivered for 30 minutes at three time points: 30 minutes before surgery, 24 hours postoperatively, and 48 hours postoperatively. Stimulation intensity will be adjusted individually in a stepwise manner, starting from the lowest level and gradually increasing until the patient perceives a tolerable tingling or paresthesia sensati

Первичные конечные точки

• PONV incidence within 48 hours postoperatively [Срок оценки: within 48 hours]
• PONV severity [Срок оценки: within 48 hours]

Вторичные конечные точки (12)

• Nausea [Срок оценки: 24 hours and 48 hours after surgery]
• Vomiting [Срок оценки: 24 hours and 48 hours after surgery]
• Retching [Срок оценки: 24 hours and 48 hours after surgery]
• Time to first flatus [Срок оценки: Up to 48 hours after surgery]
• Time to first ambulation [Срок оценки: Up to 48 hours after surgery]
• Length of hospital stay [Срок оценки: Up to 7 days after surgery]
• Bowel function recovery [Срок оценки: Up to 48 hours postoperatively]
• Quality of recovery (QoR-15) [Срок оценки: Up to 24 hours postoperatively]
• Rescue antiemetic use [Срок оценки: Up to 48 hours postoperatively]
• Number of Participants Requiring Management for Severe PONV [Срок оценки: Up to 48 hours postoperatively]
• Postoperative pain (VAS at rest) [Срок оценки: Assessed at 24, 48, and 72 hours after surgery]
• Postoperative pain (VAS on movement) [Срок оценки: Assessed at 24, 48, and 72 hours after surgery]

Критерии участия

Критерии включения

• Age 18-65 years;
• ASA physical status I-II;
• Scheduled for elective gynecological laparoscopic surgery (e.g., ovarian cystectomy, myomectomy) under general anesthesia;
• Willing to provide informed consent.

Критерии исключения

• Severe cardiac, hepatic, renal, or pulmonary disease;
• Allergy or skin disease at TEAS application site;
• Use of antiemetics within 24 hours before surgery; pregnancy or lactation;
• Vulnerable populations (e.g., critically ill, psychiatric disorders, cognitive impairment, illiteracy);
• Any condition deemed unsuitable by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07631910 · PONV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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