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临床试验/NCT03095144
NCT03095144Unknown不适用

A Retrospective Comparative Study, Post Operative Outcomes of Pyloromyotomy Procedure Under Spinal Anesthesia Compared to General Anesthesia

Bnai Zion Medical Center0 个研究点目标入组 100 人开始时间: 2017年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Total operating room time

研究概览

简要总结

Background: The purpose of this retrospective study is to evaluate surgical outcomes of pyloromyotomy in infants performed under spinal anesthesia compares to general anesthesia.

Methods: After receiving the approval of the hospital ethics committee, retrieving, reviewing files and collecting data. Primary outcomes: total operating room time, duration of surgery, pain management and postoperative apnea episodes, time of regaining full enteral feeding. Secondary outcome measures: include cardio-respiratory changes and events, and substantial vomiting postoperatively.

详细描述

After receiving of the approval of the MedicalCenter Ethics Committee, the files of all infants with hypertrophic pyloric stenosis, who were treated by open pyloromyotomy under Spinal Anesthesia and general anesthesia in Bnai-Zion Medical Center through a decade will be reviewed.

Primary outcomes: total operation time, pain assessment and management, postoperative apnea episodes and time for regaining full enteral feeding. Secondary outcome measures include, significant cardiorespiratory changes and substantial postoperative vomiting.

Full enteral feeding is defined as an infant tolerating 130 ml.kg-1 of formula a day, or breast feeding in 6-8 divided doses. Infants tolerating 2-3 full enteral feedings without complications were discharged.

Total operating room time defined as the elapsing time since entrance to the operating room until transport to the post anesthesia care unit or neonatal intensive care unit .

Surgical time is defined as the elapsing time since performing the surgical incision until wound dressing .

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
4 Weeks 至 6 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Children well hydrated: a normal serum electrolyte count;

排除标准

  • Children who's spinal puncture was unsuccessful even after a third attempt.

结局指标

主要结局

Total operating room time

时间窗: 1 hour

The elapsing time since entrance to the operating room until transport to the post anaesthesia care unit or neonatal intensive care unit in mins.

Pain management

时间窗: 1-24 hours

The CRIES score, (which is the abbreviation of C - Crying, R - Requires increase oxygen administration, I - Increased vital signs, E - Expression, S- Sleeplessness), obtained by nurses each 4 hours

Time of regaining full enteral feeding

时间窗: up to 48 hours

Time of regaining full enteral feeding

次要结局

  • Number of substantial vomiting(up to 24 hours)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

MOSTAFA.SOMRI

DIRECTOR OF ANESTHESIA DEPARTEMT

Bnai Zion Medical Center

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