Dexamethasone Palmitate for PONV After Minimally Invasive Endoscopic Surgery

NCT06981754 | Recruiting DMC

• 1 other identifier: KY2025-041-02-01
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

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, 14.0-26.3% of patients undergoing minimally invasive endoscopic procedures 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 surgery.

Conditions

Postoperative Nausea and Vomiting; Dexamethasone Palmitate; Minimally Invasive Endoscopic Procedures

Outcome Measures

Primary Outcomes (1)

• The incidence of PONV

  PONV will be defined as any nausea, emetic episodes (vomiting or retching), or both. Nausea is defined as an unpleasant sensation with an urge to vomit. Vomiting is defined as the physical event of forcefully expelling gastric contents through the mouth. Retching refers to the forced movement of gastrointestinal contents without actual expulsion of vomitus.

  Within the first 24 hours postoperatively

Secondary Outcomes (10)

• The Incidence of PONV

  At 6 hours, 48 hours, and 72 hours postoperatively

• Incidence of postoperative nausea (PON) and postoperative vomiting (POV)

  At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

• The number of vomiting or retching episodes

  Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

• The severity of PONV

  At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

• Participant satisfaction with PONV management

  At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively

Study Arms (2)

Dexamethasone palmitate group

EXPERIMENTAL

Drug: Dexamethasone palmitate

Dexamethasone group

ACTIVE COMPARATOR

Drug: Dexamethasone

Interventions

Dexamethasone palmitate DRUG

Patients in the dexamethasone palmitate group will be assigned to receive intravenous injection of dexamethasone palmitate 8 mg (contains 5mg dexamethasone) after anesthesia induction and before surgical incision.

Dexamethasone palmitate group

Dexamethasone DRUG

Patients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision.

Dexamethasone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years;
• Providing written informed consent;
• Patients scheduled to undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (10)

• Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

  PMID: 10485781 BACKGROUND

• 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.

  PMID: 32467512 BACKGROUND

• Gan TJ. Risk factors for postoperative nausea and vomiting. Anesth Analg. 2006 Jun;102(6):1884-98. doi: 10.1213/01.ANE.0000219597.16143.4D.

  PMID: 16717343 BACKGROUND

• 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.

  PMID: 24356162 BACKGROUND

• Hahm TS, Ko JS, Choi SJ, Gwak MS. 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. Anaesthesia. 2010 May;65(5):500-4. doi: 10.1111/j.1365-2044.2010.06310.x. Epub 2010 Mar 19.

  PMID: 20337618 BACKGROUND

• Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.

  PMID: 16846542 BACKGROUND

• DREAMS Trial Collaborators and West Midlands Research Collaborative. Dexamethasone versus standard treatment for postoperative nausea and vomiting in gastrointestinal surgery: randomised controlled trial (DREAMS Trial). BMJ. 2017 Apr 18;357:j1455. doi: 10.1136/bmj.j1455.

  PMID: 28420629 BACKGROUND

• Feo CV, Sortini D, Ragazzi R, De Palma M, Liboni A. Randomized clinical trial of the effect of preoperative dexamethasone on nausea and vomiting after laparoscopic cholecystectomy. Br J Surg. 2006 Mar;93(3):295-9. doi: 10.1002/bjs.5252.

  PMID: 16400707 BACKGROUND

• 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.

  PMID: 29239940 BACKGROUND

• Ren H, Zhao C, Yuan L, Meng L, Shen Y, Luo F. INDEX study: intravenous dexamethasone palmitate for prophylaxis of postoperative nausea and vomiting: a study protocol for a randomised controlled study. BMJ Open. 2025 Nov 29;15(11):e106979. doi: 10.1136/bmjopen-2025-106979.

  PMID: 41320217 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

dexamethasone 21-palmitate; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Fang Luo

CONTACT

59976661; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing Tiantan Hospital, Capital Medical University

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)