Postoperative Nausea and Vomit in Strabismus Surgery

NCT03806400 | Completed DMC

• 1 other identifier: 2018-204
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Strabismus

Keywords

Postoperative nausea and vomiting; strabismus surgery; oculocardiac reflex

Outcome Measures

Primary Outcomes (1)

• Postoperative nausea and vomiting

  Rate of postoperative nausea and vomiting

  Day 3 postoperative

Secondary Outcomes (2)

• oculocardiac reflex

  through study completion, an average of 1 hour

• Number of Participants with operated muscle

  through study completion, an average of 1 hour

Other Outcomes (1)

• Duration of surgery and anesthesia

  through study completion, an average of 1 hour

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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. -

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Strabismus; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhiying Wu, Doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 16, 2019
• Study Start: December 27, 2018
• Primary Completion: May 20, 2020
• Study Completion: September 20, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

CN (1)