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NCT Number: NCT06988124

Dexamethasone Palmitate for PONV After Craniotomy

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 65 years;
  • Providing written informed consent;
  • Perform elective craniotomy 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.

Treatment and study plan

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.

Primary outcomes

  1. The incidence of PONV

    Time frame: Within the first 24 hours postoperatively

    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.

Secondary outcomes

  1. The Incidence of PONV

    Time frame: At 6 hours, 48 hours, and 72 hours postoperatively

    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.

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

    Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

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

  3. The number of vomiting or retching episodes

    Time frame: Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

    The number of vomiting or retching episodes

  4. The severity of PONV

    Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

    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

  5. Participant satisfaction with PONV management

    Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

    Participant satisfaction will be also rated by visual analogue scales (VAS) (0 = very dissatisfied to 10 = most satisfied imaginable).

  6. The use of rescue antiemetic drugs

    Time frame: During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively

    The use of rescue antiemetic drugs

  7. The quality of postoperative recovery (QoR)

    Time frame: At 24 and 48 hours postoperatively, discharge, and 1 month postoperatively

    The quality of postoperative recovery (QoR) will be assessed by the 15-item quality of recovery scoring system [QoR-15]

  8. The VAS scale

    Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

    The VAS scale (0 = no pain to 10 = maximum pain)

  9. Postoperative length of stay (LOS)

    Time frame: Within 1 month postoperatively

    Postoperative length of stay (LOS)

  10. Safety outcomes

    Time frame: Within 1 month postoperatively

    Such as hypotension, bradycardia, hypertension, tachycardia, et al.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

59976661

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Craniotomy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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