Dexamethasone Palmitate for PONV After Open Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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, there are still some patients 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 open surgery.

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Detailed Description

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Conditions

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Postoperative Nausea and Vomiting Dexamethasone Palmitate Open Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

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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

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Inclusion Criteria

* Aged 18 to 65 years;
* Providing written informed consent;
* Perform elective open surgery (Spinal surgery, open chest surgery, open abdominal surgery) undergoing general anesthesia.

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