Penehyclidine for PONV Prophylaxis After Strabismus Surgery

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-20

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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PONV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Penehyclidine

Patients in this arm will receive penehyclidine after anesthesia intubation.

Group Type EXPERIMENTAL

Penehyclidine

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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.

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No