PONVPhase 4NCT04054479
Penehyclidine for PONV Prophylaxis After Strabismus Surgery
A Phase 4 study testing Penehyclidine and normal saline in people with PONV, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study. Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Read more about this study
- Who is it for?
- Ages 3 to 65 years
- Conditions the study is for
- PONV
- What is being tested?
- Penehyclidine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2019to 1 Nov 2019
- 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 3 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA I or II
- Aged 3-65 years
- Scheduled for elective strabismus surgery under general anesthesia
Who cannot join
- Had prior PONV
- Severe motion sickness
- A history of ophthalmic surgery
- Had received drugs known to have antiemetic effects in 24h before surgery
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery
Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study.
Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study.
The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in China) on postoperative nausea and vomiting after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.
- Conditions
- PONV
- Being tested
- Penehyclidine, normal saline
- Keywords
- Penehyclidine, PONV
- 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.
PenehyclidineDrug
Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
normal salineDrug
Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
| Study group | Role | What they receive |
|---|---|---|
| Penehyclidine | Experimental | Patients in this arm will receive penehyclidine after anesthesia intubation. Receives: Drug: Penehyclidine |
| Normal Saline | Placebo comparator | Patients in this arm will receive normal saline after anesthesia intubation. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV
Occurance of postoperative nausea and vomiting after strabismus surgery
Measured: From extubation to 48 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 posted13 Aug 2019
- Study start20 Jul 2019
- Primary completion22 Jul 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PONVStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhengnian Ding, M.D., Study chair, The First Affiliated Hospital with Nanjing Medical UniversityXiaofei Cao, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityTing Lu, M.M., Principal investigator, The First Affiliated Hospital with Nanjing Medical UniversityJiacheng Sun, M.M., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054479
- Sponsor's protocol ID
- 2019-SR-238
- Status last verified
- Dec 2019
- First submitted
- 11 Aug 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun J, Cao X, Lu T, Li N, Min X, Ding Z. Penehyclidine mitigates postoperative nausea and vomiting and intraoperative oculocardiac reflex in patients undergoing strabismus surgery: a prospective, randomized, double-blind comparison. BMC Anesthesiol. 2021 Feb 13;21(1):49. doi: 10.1186/s12871-021-01266-0.
PubMed 33581727
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery
- ClinicalTrials.gov ID
- NCT04054479
- Acronym / sponsor ID
- 2019-SR-238
- Conditions
- PONV
- Keywords
- Penehyclidine, PONV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 13 Aug 2019 (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.
Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study.
Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study.
The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in China) on postoperative nausea and vomiting after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penehyclidine | Experimental | Drug: PenehyclidinePatients in this arm will receive penehyclidine after anesthesia intubation. |
| Normal Saline | Placebo comparator | Drug: normal salinePatients in this arm will receive normal saline after anesthesia intubation. |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or II
- Aged 3-65 years
- Scheduled for elective strabismus surgery under general anesthesia
Key exclusion criteria (4 listed)
- Had prior PONV
- Severe motion sickness
- A history of ophthalmic surgery
- Had received drugs known to have antiemetic effects in 24h before surgery
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 |
|---|---|---|
| PenehyclidinePatients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation. | Drug | Penehyclidine |
| normal salinePatients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation. | Drug | Normal Saline |
Primary outcome
Incidence of PONV
Time frame: From extubation to 48 hours after surgery
Occurance of postoperative nausea and vomiting after strabismus surgery
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 17 Dec 2019.
- Derived from this study: PubMed 33581727Sun J, Cao X, Lu T, Li N, Min X, Ding Z. Penehyclidine mitigates postoperative nausea and vomiting and intraoperative oculocardiac reflex in patients undergoing strabismus surgery: a prospective, randomized, double-blind comparison. BMC Anesthesiol. 2021 Feb 13;21(1):49. doi: 10.1186/s12871-021-01266-0.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Zhengnian Ding, M.D. study chair
The First Affiliated Hospital with Nanjing Medical University
Xiaofei Cao, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
Ting Lu, M.M. principal investigator
The First Affiliated Hospital with Nanjing 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 Penehyclidine and normal saline in people with PONV, run by The First Affiliated Hospital with Nanjing 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: finished, as of the sponsor's last update on 17 Dec 2019. 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?
Incidence of PONV (time frame: From extubation to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04054479, which also lists 1 linked publication.
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 17 Dec 2019.