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临床试验/NCT03806400
NCT03806400已完成不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Postoperative nausea and vomiting

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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. -

排除标准

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

结局指标

主要结局

Postoperative nausea and vomiting

时间窗: Day 3 postoperative

Rate of postoperative nausea and vomiting

次要结局

  • oculocardiac reflex(through study completion, an average of 1 hour)
  • Number of Participants with operated muscle(through study completion, an average of 1 hour)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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