Postoperative Nausea and VomitingNCT06997419
Dexamethasone Palmitate for PONV After Open Surgery
A study testing Dexamethasone Palmitate and Dexamethasone in people with Postoperative Nausea and Vomiting and Dexamethasone Palmitate, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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, there are still some patients still experience PONV within 24 hours… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Dexamethasone Palmitate, Open Surgery
- What is being tested?
- Dexamethasone Palmitate and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years;
- Providing written informed consent;
- Perform elective open surgery (Spinal surgery, open chest surgery, open abdominal surgery) undergoing general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fang Luo
Beijing, 100050
Fang Luo, 59976661, 13611326978@163.com
About this study
Official title: Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Open Surgery
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.
- Being tested
- Dexamethasone Palmitate, Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone PalmitateDrug
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.
DexamethasoneDrug
Patients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone palmitate group | Experimental | Not described Receives: Drug: Dexamethasone Palmitate |
| Dexamethasone group | Active comparator | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 24 hours postoperatively
Secondary outcomes (10)
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.
Measured: At 6 hours, 48 hours, and 72 hours postoperatively
Incidence of postoperative nausea (PON) and postoperative vomiting (POV)
Incidence of postoperative nausea (PON) and postoperative vomiting (POV)
Measured: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
The number of vomiting or retching episodes
The number of vomiting or retching episodes
Measured: Within 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
The severity of PONV
The severity of PONV will be measured using the simplified PONV impact scoring system. The simplified PONV impact scoring system evaluates the nausea impact subscale and vomiting frequency score. Nausea impact subscale scoring will be rated by visual analogue scales (VAS) (0 = no impact to 10 = maximum impact). The VAS scores will be converted to 0-3 points via predefined thresholds. The Vomiting Frequency Score is categorized as follows: 0 for no episodes, 1 for 1-2 episodes, 2 for 3-5 episodes, and 3 for 6 or more episodes. The total score is calculated as the sum of the VAS-derived nausea impact score and the vomiting frequency score.
Measured: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Participant satisfaction with PONV management
Participant satisfaction will be also rated by visual analogue scales (VAS) (0 = very dissatisfied to 10 = most satisfied imaginable)
Measured: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
The use of rescue antiemetic drugs
The use of rescue antiemetic drugs (frequency, total intake amount, and type)
Measured: During the 0-24 hours, 24-48 hours, and 48-72 hours postoperatively
The quality of postoperative recovery (QoR)
The quality of postoperative recovery (QoR) will be assessed by the 15-item quality of recovery scoring system [QoR-15]
Measured: At 24 and 48 hours postoperatively; At discharge; At 1 month postoperatively
The VAS scale
The VAS scale (0 = no pain to 10 = maximum pain)
Measured: At 6 hours, 24 hours, 48 hours, and 72 hours postoperatively
Postoperative length of stay (LOS)
Postoperative length of stay (LOS)
Measured: Within one month after surgery
Safety outcomes
Such as hypotension, bradycardia, hypertension, tachycardia, et al.
Measured: Within one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jul 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997419
- Sponsor's protocol ID
- KY2025-041-02-02
- Status last verified
- Sep 2025
- First submitted
- 13 May 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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.
PubMed 10485781Gan 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.
PubMed 32467512Gan TJ. Risk factors for postoperative nausea and vomiting. Anesth Analg. 2006 Jun;102(6):1884-98. doi: 10.1213/01.ANE.0000219597.16143.4D.
PubMed 16717343Gan 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.
PubMed 24356162Hahm 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.
PubMed 20337618Habib 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.
PubMed 16846542Rwei 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.
PubMed 29239940
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone Palmitate for Prophylaxis of Postoperative Nausea and Vomiting After Open Surgery
- ClinicalTrials.gov ID
- NCT06997419
- Acronym / sponsor ID
- KY2025-041-02-02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone palmitate group | Experimental | Drug: Dexamethasone Palmitate |
| Dexamethasone group | Active comparator | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 65 years;
- Providing written informed consent;
- Perform elective open surgery (Spinal surgery, open chest surgery, open abdominal surgery) undergoing general anesthesia.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone PalmitatePatients 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 palmitate group |
| DexamethasonePatients in the dexamethasone group will be assigned to receive intravenous injections of dexamethasone 5 mg after anesthesia induction and before surgical incision. | Drug | Dexamethasone group |
Primary outcome
The incidence of PONV
Time frame: Within the first 24 hours postoperatively
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 10485781Apfel 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.
- Background: PubMed 32467512Gan 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.
- Background: PubMed 16717343Gan TJ. Risk factors for postoperative nausea and vomiting. Anesth Analg. 2006 Jun;102(6):1884-98. doi: 10.1213/01.ANE.0000219597.16143.4D.
- Background: PubMed 24356162Gan 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.
- Background: PubMed 20337618Hahm 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.
- Background: PubMed 16846542Habib 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.
- Background: PubMed 29239940Rwei 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Palmitate and Dexamethasone in people with Postoperative Nausea and Vomiting and Dexamethasone Palmitate, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Luo (59976661, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PONV (time frame: Within the first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997419, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.