Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06981754

Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Minimally Invasive Endoscopic Surgery

Led by Beijing Tiantan Hospital · Updated on 2025-11-18

588

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 dexamethasone for preventing postoperative nausea and vomiting (PONV) in patients undergoing minimally invasive endoscopic surgeries. Although dexamethasone is commonly used to prevent PONV, some patients still experience symptoms after surgery. Dexamethasone palmitate has a longer-lasting anti-inflammatory effect with potentially fewer side effects, making it important to study its impact in this setting. Participants will be randomly assigned to receive either an intravenous injection of dexamethasone palmitate or dexamethasone after anesthesia induction and before the surgical incision. The dexamethasone palmitate group receives 8 mg (containing 5 mg dexamethasone), while the dexamethasone group receives 5 mg. This treatment is given just before surgery to assess its role in preventing PONV. During the study, participants will be monitored for the incidence of PONV within the first 24 hours after surgery, as well as at multiple time points up to 72 hours postoperatively. Researchers will also assess nausea and vomiting episodes, severity of symptoms, rescue antiemetic use, participant satisfaction, recovery quality, pain levels using the VAS scale, length of postoperative hospital stay, and safety outcomes throughout the research period. The total participation duration includes assessments at discharge and up to one month after surgery.

CONDITIONS

Brief Title

Dexamethasone Palmitate for PONV After Minimally Invasive Endoscopic Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 65 years
  • Providing written informed consent
  • Scheduled for elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic) under general anesthesia
Not Eligible

You will not qualify if you...

  • Known allergy to dexamethasone
  • Use of any 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
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 treatment visit (in-person)

Postoperative Follow-up

Duration - Up to 1 month postoperatively

Participants are monitored for postoperative nausea and vomiting, recovery quality, and safety outcomes.

Multiple visits at 6 hours, 24 hours, 48 hours, 72 hours, discharge, and 1 month postoperatively

Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

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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Frequently Asked Questions

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Published Research Related To This Trial

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/10485781

Comparison 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/20337618

Postoperative 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/16846542

Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial).

DREAMS Trial Collaborators and West Midlands Research Collaborative

https://pubmed.ncbi.nlm.nih.gov/28420629

Randomized clinical trial of the effect of preoperative dexamethasone on nausea and vomiting after laparoscopic cholecystectomy.

C V Feo, D Sortini, R Ragazzi...

https://pubmed.ncbi.nlm.nih.gov/16400707

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/29239940

INDEX study: intravenous dexamethasone palmitate for prophylaxis of postoperative nausea and vomiting: a study protocol for a randomised controlled study.

Hao Ren, Chunmei Zhao, Linsong Yuan...

https://pubmed.ncbi.nlm.nih.gov/41320217