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Penehyclidine for PONV Prophylaxis After Strabismus Surgery

The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04054479
Enrollment
228
Registered
2019-08-13
Start date
2019-07-20
Completion date
2019-11-01
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PONV

Keywords

Penehyclidine, PONV

Brief 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. 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.

Interventions

DRUGPenehyclidine

Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.

DRUGnormal saline

Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ASA I or II * Aged 3-65 years * Scheduled for elective strabismus surgery under general anesthesia

Exclusion criteria

* Had prior PONV * Severe motion sickness * A history of ophthalmic surgery * Had received drugs known to have antiemetic effects in 24h before surgery

Design outcomes

Primary

MeasureTime frameDescription
Incidence of PONVFrom extubation to 48 hours after surgeryOccurance of postoperative nausea and vomiting after strabismus surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026