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NCT Number: NCT03806400

Postoperative Nausea and Vomit in Strabismus Surgery

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.

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Key information

Conditions

Strabismus Cranial Nerve Diseases Eye Diseases Nausea Nervous System Diseases Ocular Motility Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Primary outcomes

  1. Postoperative nausea and vomiting

    Time frame: Day 3 postoperative

    Rate of postoperative nausea and vomiting

Secondary outcomes

  1. oculocardiac reflex

    Time frame: through study completion, an average of 1 hour

    Rate of oculocardiac reflex

  2. Number of Participants with operated muscle

    Time frame: through study completion, an average of 1 hour

    Number of Participants with strabismus surgery

Other outcomes

  1. Duration of surgery and anesthesia

    Time frame: through study completion, an average of 1 hour

    Duration of surgery and anesthesia

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: PONVISS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 16, 2019
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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