Penehyclidine for PONV Prophylaxis After Strabismus Surgery

Nanjing Medical University

Status and phase: Completed; Phase 4

Conditions: PONV

Treatments: Drug: Penehyclidine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04054479

2019-SR-238

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 3 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 2 patient groups, including a placebo group

Penehyclidine

Experimental group

Description:

Patients in this arm will receive penehyclidine after anesthesia intubation.

Treatment:

Drug: Penehyclidine

Normal Saline

Placebo Comparator group

Description:

Patients in this arm will receive normal saline after anesthesia intubation.

Treatment:

Drug: normal saline