Postoperative Nausea and VomitingNCT05773950
Triple Therapy of Dexamethasone, Palonosetron, and Fosaprepitant As PONV Prevention
A study testing fosaprepitant and normal saline in people with Postoperative Nausea and Vomiting and Gynecologic Surgical Procedures, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting, Gynecologic Surgical Procedures, Laparoscopy
- What is being tested?
- fosaprepitant and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Aug 2023to Dec 2025
- 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 19 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing laparoscopic gynecological surgery.
- Adults between the ages of 18 and 50
- American Society of Anesthesiologists Physical Status (ASA physical status I, II
Who cannot join
- American Association of Anesthesiologists physical standards (ASA physical status III or higher)
- Children under the age of 19
- Adults over 49 years of age
- Diabetes Mellitus
- Pregnant or lactating women
- Patients with a history of allergy or contraindications for use of the study drug
Show all 9Show fewer
- Patients who did not understand this study or expressed their refusal.
- Patients with a history of serious psychologic disease that may affect the patient evaluation
- Patients taking serotonergic drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: a Randomized Controlled Trial
As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.
Read the detailed description
Intervention
- Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg,
- Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,
- Being tested
- fosaprepitant, normal saline
- Keywords
- PONV, fosaprepitant, dexamethasone, palonosetron
- 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.
fosaprepitantDrug
Also called emend
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
In the experimental group, the subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered.
normal salineDrug
Also called placebo
On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants.
In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Dual therapy group | Placebo comparator | On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants.
In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes.
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. Receives: Drug: normal saline |
| Triple therapy group | Experimental | On the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes.
The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. Receives: Drug: fosaprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of Postoperative nausea and vomiting
yes or no
Measured: during 24 hours after surgery
Secondary outcomes (10)
the incidence of Postoperative nausea and vomiting
yes or no
Measured: during post-anesthesia care unit stay, during 6 hours after surgery
the severity of Postoperative nausea and vomiting
numeric rating scale 0-10 and PONV impact scale
Measured: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
rescue antiemetics
dose
Measured: during 24 hours after surgery
time to rescue antiemetics
the first administration time point of rescue antiemetics
Measured: during 24 hours after surgery
postoperative pain at rest and couging
numeric rating scale 0-10
Measured: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
opioid consumption
morphine equivalent dose
Measured: during 24 hours after surgery
Any adverse event
yes or no
Measured: during 24 hours after surgery
Time to normal diet
time of succes of normal diet
Measured: during 24 hours after surgery
Qualityof recovery from surgery and anesthesia
QoR 15K questionairre
Measured: during 24 hours after surgery
Time to first flatus
gas out time pointsyes or no
Measured: during in hospital stay, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start18 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- Randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heejoon Jeong, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773950
- Sponsor's protocol ID
- SMC2022-12-050-001
- Status last verified
- Jan 2025
- First submitted
- 7 Mar 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dual Therapy of Dexamethasone and Palonosetron and Triple Therapy of Dexamethasone, Palonosetron, Fosaprepitant for Postoperative Nausea and Vomiting Prevention: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05773950
- Acronym / sponsor ID
- SMC2022-12-050-001
- Keywords
- PONV, fosaprepitant, dexamethasone, palonosetron
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Mar 2023 (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.
As a preventive for postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery, the investigators shall investigate the efficacy of the triple therapy of dexamethasone, palonosetron, and fosaprepitant comparing to dual therapy of dexamethasone and palonosetron.
Detailed description
Intervention
- Control group (dual therapy) study drug (placebo): normal saline 150ml Dexamethasone 5 mg palonosetron 0.075 mg,
- Experimental group (triple therapy) Study Drug (Fosaprepitant): resolved in normal saline 150mL Dexamethasone, Palonosetron 0.075mg,
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dual therapy group | Placebo comparator | Drug: normal salineOn the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes. The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. |
| Triple therapy group | Experimental | Drug: fosaprepitantOn the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the experimental group, 150 ml of normal saline mixed with 150 mg of fosaprepitant is administered over 30 minutes. The subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic gynecological surgery.
- Adults between the ages of 18 and 50
- American Society of Anesthesiologists Physical Status (ASA physical status I, II
Key exclusion criteria (9 listed)
- American Association of Anesthesiologists physical standards (ASA physical status III or higher)
- Children under the age of 19
- Adults over 49 years of age
- Diabetes Mellitus
- Pregnant or lactating women
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 |
|---|---|---|
| fosaprepitantAlso: emendThe subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. In the experimental group, the subject is then moved to the operating room and undergoes induction of general anesthesia. After the induction of anesthesia, 5 mg of dexamethasone and 0.075 mg of palonosetron are intravenously administered. | Drug | Triple therapy group |
| normal salineAlso: placeboOn the day of surgery, in the preoperative holding area, the principal investigator administers the study drug to the participants. During the study drug administration period, the principal investigator observes the presence of specific symptoms and abnormalities at the injection site of participants. In the case of the control group, the study drug is 150 ml of normal saline, which is visually indistinguishable from the dilute solution of the fosaprepitant, administered over 30 minutes. | Drug | Dual therapy group |
Primary outcome
the incidence of Postoperative nausea and vomiting
Time frame: during 24 hours after surgery
yes or no
10 secondary outcomes
the incidence of Postoperative nausea and vomiting
Time frame: during post-anesthesia care unit stay, during 6 hours after surgery
the severity of Postoperative nausea and vomiting
Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
rescue antiemetics
Time frame: during 24 hours after surgery
time to rescue antiemetics
Time frame: during 24 hours after surgery
postoperative pain at rest and couging
Time frame: during post-anesthesia care unit stay, during 6 hours after surgery, during 24 hours after surgery
opioid consumption
Time frame: during 24 hours after surgery
Any adverse event
Time frame: during 24 hours after surgery
Time to normal diet
Time frame: during 24 hours after surgery
Qualityof recovery from surgery and anesthesia
Time frame: during 24 hours after surgery
Time to first flatus
Time frame: during in hospital stay, an average of 5 days
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 30 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fosaprepitant and normal saline in people with Postoperative Nausea and Vomiting and Gynecologic Surgical Procedures, run by Samsung Medical Center at 1 site in South Korea.
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 9 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: enrolling by invitation, as of the sponsor's last update on 30 Mar 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of Postoperative nausea and vomiting (time frame: during 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.