Postoperative NauseaNCT04742660
The Effect of Glycyrrhizin on the Occurrence of Postoperative Nausea and Vomiting
A study testing Ammonium Glycyrrhizinate in people with Postoperative Nausea, run by Konkuk University Medical Center at 1 site in South Korea.
Trial summary
The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Postoperative Nausea
- What is being tested?
- Ammonium Glycyrrhizinate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2021to 10 Mar 2022
- Phase
- Interventional
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants scheduled to undergo breast surgery aged 20 and above
Who cannot join
- aldosteronism
- electrolyte imbalance
- myopathies
- drug addiction or suspected
- bowel disease
- allergy to drugs
- smoker
- taking any medications
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Konkuk University Medical Center
Seoul, Seoul-T'ǔkpyǒlshi, 05030
About this study
Official title: The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery
The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery
Read the detailed description
Postoperative nausea and vomiting (PONV) is one of a common complication after general anesthesia with 30-50% of incidence, increased up to 80% in high risk group. The risk factors of PONV include women population, the previous history of PONV, motion sickness in usual life, non-smoker, exposure to inhalants, perioperative opioid and laparoscopic surgery. Women population is a strong risk factor of PONV. Although perioperative management of PONV based on a guideline has been done in a lot of medical centers worldwide, the incidence of PONV is still reported relatively high.
The main ingredient of Glycyrrhizin is liquorice which has been used as antispasmodics, antiemetics or treatment for gastric ulcer in oriental medicine. Utilizing these effects of liquorice, the investigators investigate whether the addition of glycyrrhzin to conventional antiemetics is effective to decrease the incidence of PONV and improvement of severity of PONV.
- Conditions
- Postoperative Nausea
- Being tested
- Ammonium Glycyrrhizinate
- 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.
Ammonium GlycyrrhizinateDrug
Also called glycyrrhizin, gulucolin S
In control group, we assess the incidence and severity of PONV when participants are aministered ramosetron and placebo. In intervention group, the outcomes are assessed as a result of administration of ramosetron and glycyrrhizin.
| Study group | Role | What they receive |
|---|---|---|
| group R | Placebo comparator | Participants are administered a dose of 0.3mg of ramosetron (conventional antiemetics) intravenously followed by continuous infusion of 120mL normal saline at a rate of 10mL/min. Receives: Drug: Ammonium Glycyrrhizinate |
| group G | Active comparator | participants are administered a dose of 0.3mg of ramosetron followed by continuous infusion of mixture of 20mL glycyrrhizin and 100mL normal saline (total 120mL) at a rate of 10mL/min. Receives: Drug: Ammonium Glycyrrhizinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative nausea and vomiting (PONV)
assessing the incidence of postoperative nausea and vomiting with ordinal scale (0=none, 1=nausea, 2=retching, 3= vomiting)
Measured: up to 24 hours after discharge from postanesthetic care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start11 May 2021
- Primary completion8 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies 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
- Model description
- The anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizin
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ji Lee, Konkuk University Medical Center
- Investigators
- Sung-Hyop Kim, M.D. Ph.D, Study director, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742660
- Sponsor's protocol ID
- KUH
- Status last verified
- May 2022
- First submitted
- 3 Feb 2021
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery
- ClinicalTrials.gov ID
- NCT04742660
- Acronym / sponsor ID
- KUH
- Conditions
- Postoperative Nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 8 Feb 2021 (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.
The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery
Detailed description
Postoperative nausea and vomiting (PONV) is one of a common complication after general anesthesia with 30-50% of incidence, increased up to 80% in high risk group. The risk factors of PONV include women population, the previous history of PONV, motion sickness in usual life, non-smoker, exposure to inhalants, perioperative opioid and laparoscopic surgery. Women population is a strong risk factor of PONV. Although perioperative management of PONV based on a guideline has been done in a lot of medical centers worldwide, the incidence of PONV is still reported relatively high.
The main ingredient of Glycyrrhizin is liquorice which has been used as antispasmodics, antiemetics or treatment for gastric ulcer in oriental medicine. Utilizing these effects of liquorice, the investigators investigate whether the addition of glycyrrhzin to conventional antiemetics is effective to decrease the incidence of PONV and improvement of severity of PONV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizin
| Arm | Type | Receives |
|---|---|---|
| group R | Placebo comparator | Drug: Ammonium GlycyrrhizinateParticipants are administered a dose of 0.3mg of ramosetron (conventional antiemetics) intravenously followed by continuous infusion of 120mL normal saline at a rate of 10mL/min. |
| group G | Active comparator | Drug: Ammonium Glycyrrhizinateparticipants are administered a dose of 0.3mg of ramosetron followed by continuous infusion of mixture of 20mL glycyrrhizin and 100mL normal saline (total 120mL) at a rate of 10mL/min. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants scheduled to undergo breast surgery aged 20 and above
Key exclusion criteria (8 listed)
- aldosteronism
- electrolyte imbalance
- myopathies
- drug addiction or suspected
- bowel disease
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 |
|---|---|---|
| Ammonium GlycyrrhizinateAlso: glycyrrhizin, gulucolin SIn control group, we assess the incidence and severity of PONV when participants are aministered ramosetron and placebo. In intervention group, the outcomes are assessed as a result of administration of ramosetron and glycyrrhizin. | Drug | group G, group R |
Primary outcome
the incidence of postoperative nausea and vomiting (PONV)
Time frame: up to 24 hours after discharge from postanesthetic care unit (PACU)
assessing the incidence of postoperative nausea and vomiting with ordinal scale (0=none, 1=nausea, 2=retching, 3= vomiting)
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 18 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Sung-Hyop Kim, M.D. Ph.D study director
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ammonium Glycyrrhizinate in people with Postoperative Nausea, run by Konkuk University 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 1 inclusion and 8 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 18 Oct 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 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?
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?
the incidence of postoperative nausea and vomiting (PONV) (time frame: up to 24 hours after discharge from postanesthetic care unit (PACU)). 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 18 Oct 2024.