Clinical trial NCT06988124: Dexamethasone Palmitate for PONV After Craniotomy
Official title: Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Craniotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of PONV
timeFrame: Within the first 24 hours postoperatively
Secondary outcomes:
measure: The Incidence of PONV
timeFrame: At 6 hours, 48 hours, and 72 hours postoperatively
measure: Incidence of postoperative nausea (PON) and postoperative vomiting (POV)
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: The number of vomiting or retching episodes
timeFrame: Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: The severity of PONV
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: Participant satisfaction with PONV management
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: The use of rescue antiemetic drugs
timeFrame: During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively
measure: The quality of postoperative recovery (QoR)
timeFrame: At 24 and 48 hours postoperatively, discharge, and 1 month postoperatively
measure: The VAS scale
timeFrame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
measure: Postoperative length of stay (LOS)
timeFrame: Within 1 month postoperatively
measure: Safety outcomes
timeFrame: Within 1 month postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.