Dexamethasone Palmitate for PONV After Craniotomy

NCT06988124 | Recruiting DMC

• 1 other identifier: KY2025-041-02-03
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

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.

  Within the first 24 hours postoperatively

Secondary Outcomes (10)

• The Incidence of PONV

  At 6 hours, 48 hours, and 72 hours postoperatively

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

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

• The number of vomiting or retching episodes

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

• The severity of PONV

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

• Participant satisfaction with PONV management

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

Study Arms (2)

Dexamethasone palmitate group

EXPERIMENTAL

Drug: Dexamethasone Palmitate

Dexamethasone group

ACTIVE COMPARATOR

Drug: Dexamethasone

Interventions

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 palmitate group

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.

Dexamethasone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Fang Luo

Beijing, 100050, China

RECRUITING

Related Publications (3)

• Rwei AY, Sherburne RT, Zurakowski D, Wang B, Kohane DS. Prolonged Duration Local Anesthesia Using Liposomal Bupivacaine Combined With Liposomal Dexamethasone and Dexmedetomidine. Anesth Analg. 2018 Apr;126(4):1170-1175. doi: 10.1213/ANE.0000000000002719.

  PMID: 29239940 BACKGROUND

• Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.

  PMID: 32467512 BACKGROUND

• Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

  PMID: 24356162 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

dexamethasone 21-palmitate; Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Fang Luo

CONTACT

59976661; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 23, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)