About this trial

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 undergoing craniotomy 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 craniotomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 65 years;

Providing written informed consent;

Perform elective craniotomy undergoing general anesthesia.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: Dexamethasone palmitate groupExperimental treatment 1 intervention

Group B: Dexamethasone groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of PONV

PONV will be defined as any nausea, emetic episodes (vomiting or retching), or both. Nausea is defined as an unpleasant sensation with an urge to vomit. Vomiting is defined as the physical event of forcefully expelling gastric contents through the mouth. Retching refers to the forced movement of gastrointestinal contents without actual expulsion of vomitus.

Time frame

Within the first 24 hours postoperatively

Secondary outcomes

1

The Incidence of PONV

PONV will be defined as any nausea, emetic episodes (vomiting or retching), or both. Nausea is defined as an unpleasant sensation with an urge to vomit. Vomiting is defined as the physical event of forcefully expelling gastric contents through the mouth. Retching refers to the forced movement of gastrointestinal contents without actual expulsion of vomitus.

Time frame

At 6 hours, 48 hours, and 72 hours postoperatively

2

Incidence of postoperative nausea (PON) and postoperative vomiting (POV)

Time frame

At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

3

The number of vomiting or retching episodes

Time frame

Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

4

The severity of PONV

The severity of PONV will be measured using the simplified PONV impact scoring system. The simplified PONV impact scoring system evaluates the nausea impact subscale and vomiting frequency score. Nausea impact subscale scoring will be rated by visual analogue scales (VAS) (0 = no impact to 10 = maximum impact). The VAS scores will be converted to 0-3 points via predefined thresholds. The Vomiting Frequency Score is categorized as follows: 0 for no episodes, 1 for 1-2 episodes, 2 for 3-5 episodes, and 3 for 6 or more episodes. The total score is calculated as the sum of the VAS-derived nausea impact score and the vomiting frequency score

Time frame

At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

Dexamethasone Palmitate for PONV After Craniotomy

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts