A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers.
C C Apfel, E Läärä, M Koivuranta...
https://pubmed.ncbi.nlm.nih.gov/10485781Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06997419
Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Open Surgery
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 the effects and safety of dexamethasone palmitate compared to traditional dexamethasone for preventing postoperative nausea and vomiting (PONV) after open surgery. Although dexamethasone is commonly used to reduce PONV, some patients still experience symptoms within 24 hours after surgery. Dexamethasone palmitate has a longer-lasting anti-inflammatory effect and fewer side effects, making it a promising option for managing PONV. 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 surgical incision. The other group will receive an intravenous injection of dexamethasone 5 mg at the same time. The trial compares these treatments in patients undergoing elective open surgeries such as spinal, chest, or abdominal surgery. During the study, researchers will monitor participants for the incidence and severity of PONV at multiple time points within 72 hours after surgery. They will also track the use of rescue antiemetic medications, participant satisfaction with PONV management, pain levels using the VAS scale, quality of postoperative recovery, length of hospital stay, and safety outcomes up to one month after surgery. The main outcome is the occurrence of PONV within the first 24 hours postoperatively. Participation lasts through the surgery and follow-up periods as described.
CONDITIONS
Brief Title
Dexamethasone Palmitate for PONV After Open Surgery
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Provided written informed consent
- Undergoing elective open surgery (spinal, chest, or abdominal) with general anesthesia
You will not qualify if you...
- Known allergy to dexamethasone
- Used systemic glucocorticoids within 3 months before trial entry
- History of severe heart disease, liver or kidney failure, or systemic rheumatic diseases
- Cognitive impairment or severe mental illness
- Uncontrolled diabetes or infectious diseases
- Pregnant 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.
Treatment
Duration - During surgery and immediate postoperative period
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 treatment visit (in-person)
Follow-up
Duration - Up to 1 month postoperatively
Participants are monitored for postoperative nausea and vomiting, recovery quality, safety outcomes, and satisfaction for up to one month after surgery.
Multiple 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/32467512Risk factors for postoperative nausea and vomiting.
Tong J Gan
https://pubmed.ncbi.nlm.nih.gov/16717343Consensus guidelines for the management of postoperative nausea and vomiting.
Tong J Gan, Pierre Diemunsch, Ashraf S Habib...
https://pubmed.ncbi.nlm.nih.gov/24356162Comparison of the prophylactic anti-emetic efficacy of ramosetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after total knee replacement.
T S Hahm, Justin Sangwook Ko, S J Choi...
https://pubmed.ncbi.nlm.nih.gov/20337618Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis.
Ashraf S Habib, Ya-Ting Chen, Akiko Taguchi...
https://pubmed.ncbi.nlm.nih.gov/16846542Prolonged 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/29239940