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Penehyclidine for PONV Prophylaxis After Strabismus Surgery

Primary Purpose

PONV

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Penehyclidine
normal saline
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PONV focused on measuring Penehyclidine, PONV

Eligibility Criteria

3 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Penehyclidine

Normal Saline

Arm Description

Patients in this arm will receive penehyclidine after anesthesia intubation.

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

Outcomes

Primary Outcome Measures

Incidence of PONV
Occurance of postoperative nausea and vomiting after strabismus surgery

Secondary Outcome Measures

Full Information

First Posted
August 11, 2019
Last Updated
December 16, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04054479
Brief Title
Penehyclidine for PONV Prophylaxis After Strabismus Surgery
Official Title
The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PONV
Keywords
Penehyclidine, PONV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Penehyclidine
Arm Type
Experimental
Arm Description
Patients in this arm will receive penehyclidine after anesthesia intubation.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Patients in this arm will receive normal saline after anesthesia intubation.
Intervention Type
Drug
Intervention Name(s)
Penehyclidine
Intervention Description
Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
Primary Outcome Measure Information:
Title
Incidence of PONV
Description
Occurance of postoperative nausea and vomiting after strabismus surgery
Time Frame
From extubation to 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengnian Ding, M.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaofei Cao, M.D.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ting Lu, M.M.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiacheng Sun, M.M.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33581727
Citation
Sun J, Cao X, Lu T, Li N, Min X, Ding Z. Penehyclidine mitigates postoperative nausea and vomiting and intraoperative oculocardiac reflex in patients undergoing strabismus surgery: a prospective, randomized, double-blind comparison. BMC Anesthesiol. 2021 Feb 13;21(1):49. doi: 10.1186/s12871-021-01266-0.
Results Reference
derived

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Penehyclidine for PONV Prophylaxis After Strabismus Surgery

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