Penehyclidine for PONV Prophylaxis After Strabismus Surgery
NCT ID: NCT04054479
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
228 participants
INTERVENTIONAL
2019-07-20
2019-11-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Penehyclidine
Patients in this arm will receive penehyclidine after anesthesia intubation.
Penehyclidine
Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
Normal Saline
Patients in this arm will receive normal saline after anesthesia intubation.
normal saline
Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
Interventions
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Penehyclidine
Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
normal saline
Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
Eligibility Criteria
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Inclusion Criteria
* Aged 3-65 years
* Scheduled for elective strabismus surgery under general anesthesia
Exclusion Criteria
* Severe motion sickness
* A history of ophthalmic surgery
* Had received drugs known to have antiemetic effects in 24h before surgery
3 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Zhengnian Ding, M.D.
Role: STUDY_CHAIR
The First Affiliated Hospital with Nanjing Medical University
Xiaofei Cao, M.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Ting Lu, M.M.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Jiacheng Sun, M.M.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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References
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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.
Other Identifiers
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2019-SR-238
Identifier Type: -
Identifier Source: org_study_id