Penehyclidine for PONV Prophylaxis After Strabismus Surgery

Overview

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.

Full Title of Study: “The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 22, 2019

Interventions

  • Drug: Penehyclidine
    • Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
  • Drug: normal saline
    • Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.

Arms, Groups and Cohorts

  • Experimental: Penehyclidine
    • Patients in this arm will receive penehyclidine after anesthesia intubation.
  • Placebo Comparator: Normal Saline
    • Patients in this arm will receive normal saline after anesthesia intubation.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of PONV
    • Time Frame: From extubation to 48 hours after surgery
    • Occurance of postoperative nausea and vomiting after strabismus surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital with Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zhengnian Ding, M.D., Study Chair, The First Affiliated Hospital with Nanjing Medical University
    • Xiaofei Cao, M.D., Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
    • Ting Lu, M.M., Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
    • Jiacheng Sun, M.M., Principal Investigator, The First Affiliated Hospital with Nanjing Medical University

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