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Postoperative Nausea and Vomit in Strabismus Surgery (PONVISS)

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ClinicalTrials.gov Identifier: NCT03806400
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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.

Condition or disease
Strabismus

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Postoperative Nausea and Vomiting After Paediatric Strabismus Surgery: a Study of Perioperative Modifiable Risk Factors
Actual Study Start Date : December 27, 2018
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : March 20, 2019





Primary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: Day 3 postoperative ]
    Rate of postoperative nausea and vomiting


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Duration of surgery and anesthesia [ Time Frame: through study completion, an average of 1 hour ]
    Duration of surgery and anesthesia



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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. -
Criteria

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. -


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): NCT03806400


Contacts
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Contact: Zexin Chen 0086057187783629 303353479@qq.com
Contact: Zhiying Wu 0086057187315289 keyanlunli_zheer@163.com

Locations
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China, Zhejiang
The Second Affiliated Hospital, Zhejiang University School of Medicine Recruiting
Hanzhou, Zhejiang, China, 310009
Contact: Weidi Ye    +8613958092082    ywdyjj@126.com   
Contact: Yuntao Wu    +8618757186452    18757186452@qq.com   
Principal Investigator: Ying Xiang         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Zhiying Wu, Doctor Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03806400     History of Changes
Other Study ID Numbers: 2018-204
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: January 2019

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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 Second Affiliated Hospital, School of Medicine, Zhejiang University:
Postoperative nausea and vomiting
strabismus surgery
oculocardiac reflex

Additional relevant MeSH terms:
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Nausea
Postoperative Nausea and Vomiting
Vomiting
Strabismus
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases