Dexamethasone Palmitate for PONV After Open Surgery

Official title

Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Open Surgery

Overview

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, there are still some patients 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 open surgery.

Interventions

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

Primary outcome measures

• The incidence of PONV [Time frame: Within the first 24 hours postoperatively]

Secondary outcome measures (10)

• The Incidence of PONV [Time frame: At 6 hours, 48 hours, and 72 hours postoperatively]
• Incidence of postoperative nausea (PON) and postoperative vomiting (POV) [Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively]
• The number of vomiting or retching episodes [Time frame: Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively]
• The severity of PONV [Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively]
• Participant satisfaction with PONV management [Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively]
• The use of rescue antiemetic drugs [Time frame: During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively]
• The quality of postoperative recovery (QoR) [Time frame: At 24 and 48 hours postoperatively; At discharge; At 1 month postoperatively]
• The VAS scale [Time frame: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively]
• Postoperative length of stay (LOS) [Time frame: Within one month after surgery]
• Safety outcomes [Time frame: Within one month after surgery]

Eligibility criteria

Inclusion criteria

• Aged 18 to 65 years;
• Providing written informed consent;
• Perform elective open surgery (Spinal surgery, open chest surgery, open abdominal surgery) undergoing general anesthesia.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

China · 1 center

• Fang Luo — Beijing

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06997419 · KY2025-041-02-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗