Nausea and VomitingPhase 4NCT05533281
Efficacy of Three Antiemetics in Preventing Nausea and Vomiting
A Phase 4 study testing tropisetron, metoclopramide and dexamethasone in people with Nausea and Vomiting, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nausea and Vomiting
- What is being tested?
- tropisetron, metoclopramide and dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 3 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- American Society of Anesthesiologists classification I-II
- 18.5≤BMI≤28
- Patients who receiving breast and thyroid surgery and requiring general anesthesia and receive PCIA
- Voluntarily and be able to understand and sign the informed consent form
Who cannot join
- Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history
- History of allergy to opioids
- Patients with a history or family history of epilepsy that has not been controlled by treatment
- Sedatives and antidepressants were used 24 hours before surgery
- Failure to cooperate with the study for any reason or in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting
To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection
- Conditions
- Nausea and Vomiting
- Being tested
- tropisetron, metoclopramide, dexamethasone, normal saline
- Keywords
- tramadol, nausea and vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tropisetronDrug
One tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed.
metoclopramideDrug
One dose of metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
dexamethasoneDrug
One dose of dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
normal salineOther
Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed.
| Study group | Role | What they receive |
|---|---|---|
| tropisetron | Experimental | Troisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed. Receives: Drug: tropisetron |
| metoclopramide | Experimental | Metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. Receives: Drug: metoclopramide |
| dexamethasone | Experimental | Dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. Receives: Drug: dexamethasone |
| normal saline | Placebo comparator | Equal dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously to ensure constant speed. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score of nausea and vomiting
NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
Measured: From before administration to 10min after administration
Secondary outcomes (3)
Incidence of postoperative nausea and vomiting
PONV is recorded according to whether the patient present nausea and vomiting during the follow-up visits after surgery
Measured: From end of operation to 24 hours after operation
NRS score of postoperative nausea and vomiting
NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
Measured: From end of operation to 24 hours after operation
Incidence of extra treatment for postoperative nausea and vomiting
Incidence of extra treatment for postoperative nausea and vomiting was assessed by whether patient using other treatment for postoperative nausea and vomiting during the the follow-up visits after surgery
Measured: From end of operation to 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start15 Sep 2022
- Primary completion30 Oct 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangyou Duan, MD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533281
- Sponsor's protocol ID
- Nausea and vomiting
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation on the Efficacy of Three Antiemetics in Preventing Nausea and Vomiting Caused by Intravenous Tramadol Injection and Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT05533281
- Acronym / sponsor ID
- Nausea and vomiting
- Conditions
- Nausea and Vomiting
- Keywords
- tramadol, nausea and vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 9 Sep 2022 (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.
To explore the effect of commonly used antiemetic drugs on reducing nausea and vomiting caused by intravenous tramadol injection, so as to reduce the incidence of nausea and vomiting in clinical use of tramadol and provide guidance for the clinical use of tramadol injection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tropisetron | Experimental | Drug: tropisetronTroisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed. |
| metoclopramide | Experimental | Drug: metoclopramideMetoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. |
| dexamethasone | Experimental | Drug: dexamethasoneDexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. |
| normal saline | Placebo comparator | Other: normal salineEqual dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was given intravenously to ensure constant speed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists classification I-II
- 18.5≤BMI≤28
- Patients who receiving breast and thyroid surgery and requiring general anesthesia and receive PCIA
- Voluntarily and be able to understand and sign the informed consent form
Key exclusion criteria (5 listed)
- Long-term use of analgesics, psychotropic drugs (including opioids, NSAIDS, antidepressants) history
- History of allergy to opioids
- Patients with a history or family history of epilepsy that has not been controlled by treatment
- Sedatives and antidepressants were used 24 hours before surgery
- Failure to cooperate with the study for any reason or in the opinion of the investigator
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 |
|---|---|---|
| tropisetronOne tropisetron was given 30 minutes in advance, and then tramadol 1.5mg/kg was intravenously injected with a micropump at a constant speed. | Drug | tropisetron |
| metoclopramideOne dose of metoclopramide was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. | Drug | metoclopramide |
| dexamethasoneOne dose of dexamethasone was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. | Drug | dexamethasone |
| normal salineEqual dose of normal saline was given 30 minutes in advance, and then tramadol 1.5mg/kg was injected intravenously with a micropump at a constant speed. | Other | normal saline |
Primary outcome
NRS score of nausea and vomiting
Time frame: From before administration to 10min after administration
NRS score of nausea and vomiting was assessed by numerical rating scale (0-10, 0 representing no nausea and 10 the worst nausea imaginable)
3 secondary outcomes
Incidence of postoperative nausea and vomiting
Time frame: From end of operation to 24 hours after operation
NRS score of postoperative nausea and vomiting
Time frame: From end of operation to 24 hours after operation
Incidence of extra treatment for postoperative nausea and vomiting
Time frame: From end of operation to 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
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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. This study is not recruiting at the moment.
Guangyou Duan, MD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tropisetron, metoclopramide and dexamethasone in people with Nausea and Vomiting, run by The Second Affiliated Hospital of Chongqing Medical University 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 Apr 2024. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
NRS score of nausea and vomiting (time frame: From before administration to 10min after administration). 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 2 Apr 2024.