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A randomized, double-blind, controlled trial: Evaluation of the preventive effect of a combined regimen of dexamethasone, tropisetron, diphenhydramine and scopolamine in female patients at high risk of postoperative nausea and vomiting after abdominal surgery.

randomized, double-blind, controlled trial: Evaluation of the preventive effect of a combined regimen of dexamethasone, tropisetron, diphenhydramine and scopolamine in female patients at high risk of postoperative nausea and vomiting after abdominal surgery.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125098
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and vomiting after female abdominal surgery

Interventions

intervention group:Four hours before the operation, a scopolamine patch (1.5mg/72h) was adhered to the back of the ear through the skin. Before anesthesia induction, 5 mg of dexamethasone and 25 mg of
control group:Four hours before the operation began, placebo patches with the same appearance were applied
5 mg of dexamethasone + normal saline (equal volume) was given intravenously before anesthesia induction
2 mg of tropisetron was given at the end of the operation.

Sponsors

Air Force Characteristic Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 to 65 years old, with a body mass index (BMI) of >= 18 and = 1 hour ; 4. No history of drug allergies, no contraindications to anesthesia ; 5. Stable vital signs, accompanied by family members during the visit ; 6. Willing to participate in this study and signing the informed consent form for informed consent to this study.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to the study drugs (dexamethasone, tropisetron, diphenhydramine, scopolamine); 2. Have a history of angle-closure glaucoma, myasthenia gravis, severe urinary retention, pyloric obstruction or intestinal obstruction; 3. Have used antiemetic drugs, antihistamines or anticholinergic drugs within 24 hours before the surgery; 4. Have a long-term history of taking opioid drugs; 5. Have concurrent severe heart, liver, kidney or other diseases; 6. Have organ damage caused by diabetes and high blood sugar; 7. Have undergone major surgeries recently; 8. Pregnant or lactating women; 9. Have mental disorders or cognitive dysfunction and cannot cooperate with the assessment; 10. Have skin diseases that cannot be adhered to the transdermal patches; 11. Lack self-care ability or are individuals with incomplete behavioral capacity.

Design outcomes

Primary

MeasureTime frame
Postoperative Nausea and Vomiting Score Within 24 Hours;

Secondary

MeasureTime frame
The incidence of PONV;Record the usage of preventive antiemetic drugs (including the drugs, doses, and times). Record the data of the PCA pump: the total number of effective compressions and the total duration of PCA use. During the 24-hour follow-up after the surgery, inquire about the patient's satisfaction and record any adverse events.;

Countries

China

Contacts

Public ContactLi Jin

Air Force Characteristic Medical Center

sny380578306@163.com+86 180 1002 0467

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026