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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: Dexamethasone (intravenous); Device: Transcutaneous electrical acupoint stimulation (TEAS); Drug: Amisulpride Injection

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhengjie Chen, M.D.; Phone Number: 86 13634226323; Email: chenzhengjie@zju.edu.cn
• Study Contact Backup: Name: Gang Chen, M.D.; Phone Number: 86 13757118681; Email: chengang120@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Contact: Youjia Yu, M.D.; Phone Number: 86 15995864437; Email: yuyoujia0717@163.com
      • Contact: Xiujun Cai, M.D.; Phone Number: 0571-86090073; Email: cxjzu@hotmail.com
      • Principal Investigator: Zhengjie Chen, M.D.
      • Sub-Investigator: Liangyu Zheng, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEAS + Dexamethasone; Participants in this arm receive both transcutaneous electrical acupoint stimulation (TEAS) and dexamethasone. 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 sensation. The highest well-tolerated intensity will then be maintained for treatment. Dexamethasone: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.	Drug: Dexamethasone (intravenous); Dexamethasone: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.; Device: 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 sensation. The highest well-tolerated intensity will then be maintained for treatment.
Experimental: TEAS + Amisulpride; Participants in this arm receive both transcutaneous electrical acupoint stimulation (TEAS) and amisulpride. 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 sensation. The highest well-tolerated intensity will then be maintained for treatment. Amisulpride: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.	Device: 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 sensation. The highest well-tolerated intensity will then be maintained for treatment.; Drug: Amisulpride Injection; Amisulpride：Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.
Experimental: Sham stimulation + Dexamethasone; Participants in this arm receive both sham transcutaneous electrical acupoint stimulation (TEAS) and dexamethasone. Sham stimulation: Electrodes are placed at the P6 acupoint (inner forearm, approximately 2 cun proximal to the wrist crease) for 30 minutes at three time points: 30 minutes before surgery, 24 hours postoperatively, and 48 hours postoperatively. The device is attached but does not deliver any electrical output (no current). Participants are blinded to the stimulation status. Dexamethasone: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.	Drug: Dexamethasone (intravenous); Dexamethasone: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.
Experimental: Sham stimulation + Amisulpride; Participants in this arm receive both sham transcutaneous electrical acupoint stimulation (TEAS) and amisulpride. Sham stimulation: Electrodes are placed at the P6 acupoint (inner forearm, approximately 2 cun proximal to the wrist crease) for 30 minutes at three time points: 30 minutes before surgery, 24 hours postoperatively, and 48 hours postoperatively. The device is attached but does not deliver any electrical output (no current). Participants are blinded to the stimulation status. Amisulpride: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.	Drug: Amisulpride Injection; Amisulpride：Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV incidence within 48 hours postoperatively	Proportion of patients experiencing nausea, vomiting, or retching.	within 48 hours
PONV severity	Assessed using a 4-grade scale: Grade 0 = no nausea or vomiting Grade 1 = nausea only Grade 2 = vomiting or retching Grade 3 = refractory nausea and vomiting	within 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	The number of nausea episodes recorded after surgery	24 hours and 48 hours after surgery
Vomiting	The number of vomiting episodes recorded after surgery.	24 hours and 48 hours after surgery
Retching	The number of retching episodes recorded after surgery.	24 hours and 48 hours after surgery
Time to first flatus	The time from the end of surgery to the first passage of flatus after transfer from the post-anesthesia care unit (PACU) to the ward.	Up to 48 hours after surgery
Time to first ambulation	The time from the end of surgery to the patient's first out-of-bed activity.	Up to 48 hours after surgery
Length of hospital stay	Duration of postoperative hospitalization, measured in days.	Up to 7 days after surgery
Bowel function recovery	Assessed by the time of defecation.	Up to 48 hours postoperatively
Quality of recovery (QoR-15)	QoR-15 questionnaire score ranging from 0 to 150, covering 15 dimensions including physical comfort, emotional state, and psychological well-being.	Up to 24 hours postoperatively
Rescue antiemetic use	The type and number of rescue antiemetic medications required when a patient experiences PONV postoperatively.	Up to 48 hours postoperatively
Number of Participants Requiring Management for Severe PONV	Number of participants with severe postoperative nausea and vomiting, such as persistent vomiting or retching, requiring urgent additional amisulpride or other interventions.	Up to 48 hours postoperatively
Postoperative pain (VAS at rest)	Pain intensity measured at rest using a Visual Analogue Scale (0 = no pain, 10 = worst possible pain).	Assessed at 24, 48, and 72 hours after surgery
Postoperative pain (VAS on movement)	Pain intensity measured during movement (e.g., turning, coughing) using a Visual Analogue Scale (0 = no pain, 10 = worst possible pain).	Assessed at 24, 48, and 72 hours after surgery
Postoperative opioid consumption	Total amount of opioids consumed after surgery.	Assessed at 48 hours after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related adverse events	Adverse events associated with TEAS or sham stimulation, including local skin irritation, burning sensation, redness, itching, blistering, or mild burns at the electrode site.	Assessed after TEAS treatment before surgery, 24 hours after surgery, and 48 hours after surgery.
Drug-related adverse events	Adverse events related to dexamethasone or amisulpride, including but not limited to headache, dizziness, constipation, diarrhea, facial flushing, QT prolongation, allergic reactions (rash, dyspnea, hypotension), transient hyperglycemia, and blood pressure fluctuations.	Assessed at 24 and 48 hours after surgery.
Proportion of Participants Receiving Intraoperative Vasoactive Drugs	Proportion of participants who received any vasoactive medication during surgery.	Intraoperative period
Postoperative complications	Occurrence of complications after surgery, including infection, shivering, and urinary retention.	Up to 7 days after surgery
Headache	Number of patients with postoperative headache	24 hours and 48 hours after surgery
Dizziness	Number of patients with postoperative dizziness	24 hours and 48 hours after surgery

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Investigators: Study Chair: Youjia Yu, M.D., Sir Run Run Shaw Hospital; Principal Investigator: Gang Chen, M.D., Sir Run Run Shaw Hospital; Study Director: Zhengjie Chen, M.D., Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Nausea and Vomiting; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Polycyclic Compounds; Amides; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzene Derivatives; Pregnadienetriols; Acids, Carbocyclic; Benzoates; Benzamides; Amisulpride; Dexamethasone
• Other Study ID Numbers: PONV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

No participant consent for data sharing

Ethical approval does not permit it

Chinese regulations restrict sharing of sensitive health data

No data sharing agreement or infrastructure in place

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No