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Penehyclidine for PONV Prophylaxis After Strabismus Surgery

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ClinicalTrials.gov Identifier: NCT04054479
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Study Description
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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.


Condition or disease Intervention/treatment Phase
PONV Drug: Penehyclidine Drug: normal saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery
Actual Study Start Date : July 20, 2019
Actual Primary Completion Date : July 22, 2019
Actual Study Completion Date : November 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Penehyclidine
Patients in this arm will receive penehyclidine after anesthesia intubation.
 Drug: Penehyclidine
Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
Placebo Comparator: Normal Saline
Patients in this arm will receive normal saline after anesthesia intubation.
 Drug: normal saline
Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of PONV [ Time Frame: From extubation to 48 hours after surgery ]
    Occurance of postoperative nausea and vomiting after strabismus surgery


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054479


Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Chair: Zhengnian Ding, M.D. The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Xiaofei Cao, M.D. The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Ting Lu, M.M. The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Jiacheng Sun, M.M. The First Affiliated Hospital with Nanjing Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04054479    
Other Study ID Numbers: 2019-SR-238
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Penehyclidine
PONV
Additional relevant MeSH terms:
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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases