Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Tong J Gan, Kumar G Belani, Sergio Bergese...
https://pubmed.ncbi.nlm.nih.gov/32467512/Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2025-09-23
500
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating dexamethasone palmitate to prevent postoperative nausea and vomiting PONV in patients undergoing craniotomy. Although dexamethasone is commonly used for PONV prevention, some patients still experience symptoms within 24 hours after surgery. This trial assesses whether dexamethasone palmitate, which has a longer-lasting anti-inflammatory effect and fewer side effects, can improve PONV outcomes after craniotomy. Participants will be randomly assigned to one of two groups. One group will receive an intravenous injection of dexamethasone palmitate 8 mg, containing 5 mg dexamethasone after anesthesia induction and before the surgical incision. The other group will receive an intravenous injection of dexamethasone 5 mg at the same timing. Both treatments are given before the surgery begins to study their effects on PONV. During the study, participants will be monitored for PONV incidence within the first 24 hours and at 6, 24, 48, and 72 hours after surgery. Researchers will track nausea and vomiting episodes, severity of symptoms, use of rescue antiemetics, participant satisfaction, recovery quality, pain scores, length of hospital stay, and safety outcomes for up to one month postoperatively. This comprehensive monitoring will help evaluate the effectiveness and safety of dexamethasone palmitate compared to dexamethasone in preventing PONV after craniotomy.
CONDITIONS
Dexamethasone Palmitate for PONV After Craniotomy
F
Fang Luo
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Beijing Tiantan Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single administration on the day of surgery
Participants receive an intravenous injection of either dexamethasone palmitate or dexamethasone after anesthesia induction and before surgical incision to prevent postoperative nausea and vomiting.
1 baseline visit (day of surgery) and multiple assessments within 72 hours postoperatively
Duration - Up to 1 month postoperatively
Participants are monitored for postoperative recovery, nausea, vomiting, and safety outcomes up to 1 month after surgery.
Assessments at 6 hours, 24 hours, 48 hours, 72 hours, discharge, and 1 month postoperatively
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor