NCT04054479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

2 days

First QC Date

August 11, 2019

Last Update Submit

December 16, 2019

Conditions

PONV

Keywords

PenehyclidinePONV

Outcome Measures

Primary Outcomes (1)

  • Incidence of PONV

    Occurance of postoperative nausea and vomiting after strabismus surgery

    From extubation to 48 hours after surgery

Study Arms (2)

Penehyclidine

EXPERIMENTAL

Patients in this arm will receive penehyclidine after anesthesia intubation.

Drug: Penehyclidine

Normal Saline

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

PenehyclidineDRUG

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

Penehyclidine
normal salineDRUG

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

Normal Saline

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II
  • Aged 3-65 years
  • Scheduled for elective strabismus surgery under general anesthesia

You may not qualify if:

  • Had prior PONV
  • Severe motion sickness
  • A history of ophthalmic surgery
  • Had received drugs known to have antiemetic effects in 24h before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

  • 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.

    PMID: 33581727DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

penehyclidineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Zhengnian Ding, M.D.

    The First Affiliated Hospital with Nanjing Medical University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2019

First Posted

August 13, 2019

Study Start

July 20, 2019

Primary Completion

July 22, 2019

Study Completion

November 1, 2019

Last Updated

December 17, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)