Postoperative Nausea and Vomit in Strabismus Surgery (PONVISS)

December 16, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Postoperative Nausea and Vomiting After Paediatric Strabismus Surgery: a Study of Perioperative Modifiable Risk Factors

Postoperative nausea and vomiting (PONV) is a major concern in paediatric inpatient surgery and may increase patient discomfort, delay patient discharge, and increase the cost of patient care. The incidence of PONV after strabismus surgery is relatively high, compared with other inpatient surgeries, particularly in children. Oculocardiac reflex (OCR) is a phenomenon defined by bradycardia or dysrhythmia during strabismus surgery. Oculocardiac reflex is commonly caused by the traction on the extraocular muscle (EOM), which, through the ophthalmic branch of trigeminal nerve, stimulates the vagal center. The afferent arm of the reflex is the ophthalmic branch of the trigeminal nerve, and the efferent arm is the vagus nerve, which diminishes sinoatrial node impulses and leads to bradycardia.While there is a general consensus regarding the role of unmodifiable risk factors for PONV, including the number of muscle and the occurrence of Oculocardiac reflex or not, the role of modifiable risk factors, such as duration of surgery and anesthesia and perioperatively administered medications, is still disputed. In the present study, the investigators evaluated whether these factors may be associated with postoperative nausea and vomiting after paediatric strabismus surgery while controlling for a range of covariates.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The primary outcome was incidence of PONV that occurred within 3 days after the operation. The investigators defined PONV as a presence of either nausea or vomiting. In study hospital, it was routine for nurses to assess and record nausea and vomiting every 8 hours for all postoperative patients during postoperative 3 days. Accordingly, the investigators retrospectively collected the presence of PONV from electrical medical records. If patients had discharged hospital within postoperative 3 days, the incidence of PONV was assessed solely during hospital stay. The data, collected included information regarding age at surgery, gender, and type of strabismus. During strabismus surgery, the number and sequence of the operated muscles, HR before traction of the EOM (baseline HR), maximum decreased HR after traction of the EOM, HR at maximum recovery from decreased HR and maintained during traction of the EOM (adrenergic HR), and HR at the cutting of the muscle, were collected. Oculocardiac reflex was defined as a decrease in HR greater than or equal to 20% rather than maximum at first traction of the muscle.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients aged from 2-14 years who underwent strabismus surgery under general anesthesia between January 2018 and November 2018 were included in this study. -

Description

Inclusion Criteria:All patients aged from 2-14 years who underwent strabismus surgery under general anesthesia between January 2018 and November 2018 were included in this study. -

Exclusion Criteria:patients with American Society of Anesthesiologists (ASA) physical status III or higher. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: Day 3 postoperative
Rate of postoperative nausea and vomiting
Day 3 postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
oculocardiac reflex
Time Frame: through study completion, an average of 1 hour
Rate of oculocardiac reflex
through study completion, an average of 1 hour
Number of Participants with operated muscle
Time Frame: through study completion, an average of 1 hour
Number of Participants with strabismus surgery
through study completion, an average of 1 hour

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of surgery and anesthesia
Time Frame: through study completion, an average of 1 hour
Duration of surgery and anesthesia
through study completion, an average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zhiying Wu, Doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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