Nausea and VomitingPhase 1/2NCT06045364
Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
A Phase 1/2 study testing Glycopyrrolate and Anisodamine in people with Nausea and Vomiting, run by Jie Chen at 1 site in China.
Trial summary
This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting
- What is being tested?
- Glycopyrrolate and Anisodamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Jul 2024
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP
Who cannot join
- 2: pregnancy
- 3: glaucoma
- 4: Myasthenia gravis
- 5: Obstructive gastrointestinal diseases
- 6: Obstructive urinary tract disease (prostatic hyperplasia)
- 7: Heart disease (coronary heart disease, congestive heart failure)
Show all 10Show fewer
- 8: hyperthyroidism
- 9: Previous history of abdominal or intestinal surgery
- 10: Chronic renal failure
- -
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.
Read the detailed description
This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.
Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events
- Conditions
- Nausea and Vomiting
- Being tested
- Glycopyrrolate, Anisodamine
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously
AnisodamineDrug
During induction of anesthesia,10mg of Anisodamine was given intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrrolate | Experimental | During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants. Receives: Drug: Glycopyrrolate |
| Anisodamine Group | Active comparator | During induction of anesthesia,10mg of Anisodamine was given intramuscular injection Receives: Drug: Anisodamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
Measured: Timepoint：24 hours after the ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023
- Primary completion20 Jul 2024
- Study completion31 Jul 2024
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Chen, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Guangyou Duan, doctor, Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045364
- Sponsor's protocol ID
- 2023-115
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2023
- Last updated
- 5 Sep 2024
- Results posted
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
- ClinicalTrials.gov ID
- NCT06045364
- Acronym / sponsor ID
- 2023-115
- Conditions
- Nausea and Vomiting
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jie ChenUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Sep 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.
This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.
Detailed description
This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.
Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycopyrrolate | Experimental | Drug: GlycopyrrolateDuring induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants. |
| Anisodamine Group | Active comparator | Drug: AnisodamineDuring induction of anesthesia,10mg of Anisodamine was given intramuscular injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP
Key exclusion criteria (10 listed)
- 2: pregnancy
- 3: glaucoma
- 4: Myasthenia gravis
- 5: Obstructive gastrointestinal diseases
- 6: Obstructive urinary tract disease (prostatic hyperplasia)
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 |
|---|---|---|
| GlycopyrrolateDuring induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously | Drug | Glycopyrrolate |
| AnisodamineDuring induction of anesthesia,10mg of Anisodamine was given intramuscular injection. | Drug | Anisodamine Group |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: Timepoint：24 hours after the ERCP
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 5 Sep 2024.
- Individual participant dataSharing planned: No
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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, doctor study director
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 1/2 study testing Glycopyrrolate and Anisodamine in people with Nausea and Vomiting, run by Jie Chen 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 1 inclusion and 10 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 5 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Incidence of postoperative nausea and vomiting (time frame: Timepoint：24 hours after the ERCP). 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 5 Sep 2024.