Penehyclidine for PONV Prophylaxis After Strabismus Surgery

Phase 4

Completed

• Conditions: PONV
• Interventions: Drug: normal saline; Drug: Penehyclidine

• Registration Number: NCT04054479
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-20
• Primary Completion: 2019-07-22
• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Completion: 2019-11-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	normal saline	Patients in this arm will receive normal saline after anesthesia intubation.
Penehyclidine	Penehyclidine	Patients in this arm will receive penehyclidine after anesthesia intubation.

Primary Outcome Measures

Name	Time	Method
Incidence of PONV	From extubation to 48 hours after surgery	Occurance of postoperative nausea and vomiting after strabismus surgery

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China