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Completed

NCT Number: NCT04054479

Penehyclidine for PONV Prophylaxis After Strabismus Surgery

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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Key information

Conditions

PONV Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

3 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Penehyclidine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Incidence of PONV

    Time frame: From extubation to 48 hours after surgery

    Occurance of postoperative nausea and vomiting after strabismus surgery

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2019
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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