Postoperative Nausea and VomitingPhase 4NCT05265507
Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron
A Phase 4 study testing Glycopyrronium and Ondansetron in people with Postoperative Nausea and Vomiting, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
To compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Glycopyrronium and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2022to 30 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification I-III
- Receive general anesthesia
- Voluntarily receive postoperative intravenous controlled analgesia
Who cannot join
- Puerpera or lactation women
- Allergy or existing contraindication to glycopyrronium and ondansetron
- Participate in other clinical drug trials within three months
- Can not follow with the study procedure
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Guangyou Duan, MD, (+86)18323376014, duangy@hospital.cqmu.edu.cn
About this study
Official title: Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study
To compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Glycopyrronium, Ondansetron
- 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.
GlycopyrroniumDrug
Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
OndansetronDrug
Glycopyrronium (4mg) was intravenously given at the ending of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrronium | Experimental | Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery. Receives: Drug: Glycopyrronium |
| Ondansetron | Active comparator | Ondansetron (4mg) was intravenously given at the ending of the surgery. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative nausea and vomiting
postoperative nausea and vomiting is recorded according to follow-up visits after surgery
Measured: from the ending of surgery to 24 hours after surgery
Secondary outcomes (3)
intensity of postoperative nausea
intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)
Measured: from the ending of surgery to 24 hours after surgery
incidence of postoperative vomiting
postoperative vomiting is recorded according to follow-up visits after surgery
Measured: from the ending of surgery to 24 hours after surgery
incidence of intervention requirement for nausea and vomiting
this event is recorded according to follow-up visits after surgery
Measured: from the ending of surgery to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start21 Mar 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing University Jiangjin Hospital, Chongqing Medical University, The People's Hospital of DAZU ，Chongqing, Xiangya Hospital of Central South University, West China Hospital, The People's Hospital of Tongliang District， Chongqing city, Chongqing Medical Center for Women and Children, Dianjiang People's Hospital of Chongqing, The Ninth People's Hospital of Chongqing, The People's Hospital of Yubei District of Chongqing city, Chongqing Yongchuan District People's Hospital, The First People's Hospital Of Chongqing Liang Jiang New Area, ChongGang General Hospital, The People's Hospital of Nanchuan, People's Hospital of Pengshui County, Yunyang people's Hospital, Chongqing Liangping District People's Hospital, Jiulongpo People's Hospital of chongqing, The People's Hospital of Qijiang District，Chongqing, University-Town Hospital of Chongqing Medical University, Chongqing Public Health Medical Center, CHONGQING BANAN HOSPITAL OF TCM
- Responsible party
- Sponsor
- Investigators
- He Huang, MD, Principal investigator, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265507
- Sponsor's protocol ID
- Glycopyrronium and ondansetron
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 24 Feb 2023
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study
- ClinicalTrials.gov ID
- NCT05265507
- Acronym / sponsor ID
- Glycopyrronium and ondansetron
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- Chongqing University Jiangjin Hospital, Chongqing Medical University, The People's Hospital of DAZU ，Chongqing, Xiangya Hospital of Central South University, West China Hospital, The People's Hospital of Tongliang District， Chongqing city, Chongqing Medical Center for Women and Children, Dianjiang People's Hospital of Chongqing, The Ninth People's Hospital of Chongqing, The People's Hospital of Yubei District of Chongqing city, Chongqing Yongchuan District People's Hospital, The First People's Hospital Of Chongqing Liang Jiang New Area, ChongGang General Hospital, The People's Hospital of Nanchuan, People's Hospital of Pengshui County, Yunyang people's Hospital, Chongqing Liangping District People's Hospital, Jiulongpo People's Hospital of chongqing, The People's Hospital of Qijiang District，Chongqing, University-Town Hospital of Chongqing Medical University, Chongqing Public Health Medical Center, CHONGQING BANAN HOSPITAL OF TCM
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 3 Mar 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 compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycopyrronium | Experimental | Drug: GlycopyrroniumGlycopyrronium (0.2mg) was intravenously given at the ending of the surgery. |
| Ondansetron | Active comparator | Drug: OndansetronOndansetron (4mg) was intravenously given at the ending of the surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists classification I-III
- Receive general anesthesia
- Voluntarily receive postoperative intravenous controlled analgesia
Key exclusion criteria (4 listed)
- Puerpera or lactation women
- Allergy or existing contraindication to glycopyrronium and ondansetron
- Participate in other clinical drug trials within three months
- Can not follow with the study procedure
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 |
|---|---|---|
| GlycopyrroniumGlycopyrronium (0.2mg) was intravenously given at the ending of the surgery. | Drug | Glycopyrronium |
| OndansetronGlycopyrronium (4mg) was intravenously given at the ending of the surgery. | Drug | Ondansetron |
Primary outcome
incidence of postoperative nausea and vomiting
Time frame: from the ending of surgery to 24 hours after surgery
postoperative nausea and vomiting is recorded according to follow-up visits after surgery
3 secondary outcomes
intensity of postoperative nausea
Time frame: from the ending of surgery to 24 hours after surgery
incidence of postoperative vomiting
Time frame: from the ending of surgery to 24 hours after surgery
incidence of intervention requirement for nausea and vomiting
Time frame: from the ending of surgery to 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- 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.
He Huang, MD principal investigator
The Second Affiliated Hospital, 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 Glycopyrronium and Ondansetron in people with Postoperative 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangyou Duan, MD ((+86)18323376014, duangy@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative nausea and vomiting (time frame: from the ending of surgery to 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 24 Feb 2023.