Prolonged Duration Local Anesthesia Using Liposomal Bupivacaine Combined With Liposomal Dexamethasone and Dexmedetomidine.
Alina Y Rwei, Robert T Sherburne, David Zurakowski...
https://pubmed.ncbi.nlm.nih.gov/29239940Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06988124
Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Craniotomy
Led by Beijing Tiantan Hospital · Updated on 2025-09-23
500
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Brief Title
Dexamethasone Palmitate for PONV After Craniotomy
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Providing written informed consent
- Scheduled for elective craniotomy under general anesthesia
You will not qualify if you...
- Known allergy to dexamethasone
- Use of systemic glucocorticoids within 3 months before the trial
- History of severe heart disease, liver or kidney failure, or systemic rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, or systemic lupus erythematosus
- Cognitive impairment or severe mental illness
- Uncontrolled diabetes or infectious diseases
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
Fang Luo
Beijing, China, 100050
Actively Recruiting
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Research Team
F
Fang Luo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
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/32467512Consensus guidelines for the management of postoperative nausea and vomiting.
Tong J Gan, Pierre Diemunsch, Ashraf S Habib...
https://pubmed.ncbi.nlm.nih.gov/24356162