Dexamethasone Palmitate for PONV After Minimally Invasive Endoscopic Surgery

NCT ID: NCT06981754

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-12-31

Brief Summary

Dexamethasone is almost one of the most commonly used drugs for postoperative nausea and vomiting (PONV) prevention. However, PONV is still a complex problem to be solved; for example, even with preoperative dexamethasone administration, 14.0-26.3% of patients undergoing minimally invasive endoscopic procedures still experience PONV within 24 hours postoperatively. Compared to dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, 2-5 times that of traditional water-soluble dexamethasone, with fewer adverse effects. This trial aims to assess the effect and safety of preoperative dexamethasone palmitate on PONV after surgery.

Conditions

Postoperative Nausea and Vomiting; Dexamethasone Palmitate; Minimally Invasive Endoscopic Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dexamethasone palmitate group

Group Type: EXPERIMENTAL

Dexamethasone palmitate

Intervention Type: DRUG

Patients in the dexamethasone palmitate group will be assigned to receive intravenous injection of dexamethasone palmitate 8 mg (contains 5mg dexamethasone) after anesthesia induction and before surgical incision.

Dexamethasone group

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Patients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision.

Interventions

Dexamethasone palmitate

Patients in the dexamethasone palmitate group will be assigned to receive intravenous injection of dexamethasone palmitate 8 mg (contains 5mg dexamethasone) after anesthesia induction and before surgical incision.

Intervention Type: DRUG

Dexamethasone

Patients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18 to 65 years;
• Providing written informed consent;
• Patients scheduled to undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia.

Exclusion Criteria

• Known to be allergic to dexamethasone;
• Any systemic glucocorticoids within 3 months before trial entry;
• History of severe heart disease, liver/kidney failure, or systemic rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, et al);
• Cognitive impairment or severe mental illness;
• Uncontrolled diabetes or infectious diseases;
• Pregnancy or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Beijing Tiantan Hospital, Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang Luo

Role: CONTACT

13611326978@163.com

59976661

Facility Contacts

Luo Fang, M.D.

Role: primary

13611326978@163.com

+86 13611326978

References

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Reference Type: BACKGROUND

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Other Identifiers

KY2025-041-02-01

Identifier Type: -

Identifier Source: org_study_id