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

NCT07631910 | Not Yet Recruiting

• 1 other identifier: PONV
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Study Objectives To evaluate the preventive effect of TEAS on PONV in patients undergoing gynecological laparoscopic surgery, compared with sham stimulation.
3. 3.Study Design Design type: 2×2 factorial, randomized, double-blind (participants, outcome assessors, and data analysts blinded to group assignment).
4. 4.Sample Size Calculation Assumptions: PONV incidence 50% in control groups, 30% in TEAS groups; two-sided α = 0.05; power = 80%.
5. 5.Data Management and Confidentiality Electronic Data Capture (EDC) system with unique coding (no direct identifiers).
6. 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. 7.Adverse Event Management Dexamethasone-related AEs (transient hyperglycemia, blood pressure fluctuation, gastrointestinal discomfort, rare allergic reactions).

Conditions

Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Nausea

  24 hours and 48 hours after surgery

• Vomiting

  24 hours and 48 hours after surgery

• Retching

  24 hours and 48 hours after surgery

• Time to first flatus

  Up to 48 hours after surgery

• Time to first ambulation

  Up to 48 hours after surgery

Other Outcomes (6)

• Device-related adverse events

  Assessed after TEAS treatment before surgery, 24 hours after surgery, and 48 hours after surgery.

• Drug-related adverse events

  Assessed at 24 and 48 hours after surgery.

• Proportion of Participants Receiving Intraoperative Vasoactive Drugs

  Intraoperative period

Study Arms (4)

TEAS + Dexamethasone

EXPERIMENTAL

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); Device: Transcutaneous electrical acupoint stimulation (TEAS)

TEAS + Amisulpride

EXPERIMENTAL

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.

Drug: Amisulpride Injection; Device: Transcutaneous electrical acupoint stimulation (TEAS)

Sham stimulation + Dexamethasone

EXPERIMENTAL

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)

Sham stimulation + Amisulpride

EXPERIMENTAL

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

Interventions

Amisulpride Injection DRUG

Amisulpride：Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.

Sham stimulation + Amisulpride; TEAS + Amisulpride

Dexamethasone (intravenous) DRUG

Dexamethasone: Administered intravenously at a dose of 5 mg, 30 minutes before the end of surgery.

Sham stimulation + Dexamethasone; TEAS + Dexamethasone

Transcutaneous electrical acupoint stimulation (TEAS) DEVICE

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.

TEAS + Amisulpride; TEAS + Dexamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Amisulpride; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Youjia Yu, M.D.

  Sir Run Run Shaw Hospital

  STUDY CHAIR

• Gang Chen, M.D.

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Zhengjie Chen, M.D.

  Sir Run Run Shaw Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhengjie Chen, M.D.

CONTACT

86 13634226323; chenzhengjie@zju.edu.cn

Gang Chen, M.D.

CONTACT

86 13757118681; chengang120@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Anesthesiology

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)