Effect Of Dexmedetomidine Infusion On Surgical Pleth Index In Pediatrics Undergoing Hypospadias Repair; A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Surgical pleth index number
研究概览
简要总结
This non-invasive dimensionless score index -SPI-reflects the Patients' sympathetic response to surgical stimulation. Its effectiveness in detecting the balance between nociceptor activation and analgesia was not only reported but also, was reported to be superior to the other parameters like blood pressure and heart rate. SPI value is correlated to pain and ranges from 0 to 100, higher values indicate strong surgical stimulus. Its value is obtained from photoplethysmographic amplitude (PPGA) and heart rate (HR) data from pulse oximetry measurement.
Prediction of the severity of postoperative pain using SPI in both adults and children has been reported by several studies. So, the authors hypothesize that dexmedetomidine infusion without giving a bolus dose may affect the SPI in pediatrics undergoing hypospadias repair.
详细描述
After obtaining Fayoum University's ethical committee permission and as well as the informed consent from the parents, 90 patients aged 1 to 7 years old scheduled for hypospadias repair will be randomly assigned into 2 groups.
Preoperative Assessment:
All patients will be assessed clinically and investigated for exclusion of any of the above-mentioned contraindications.
Perioperative Management:
Patients will receive no premedication. After entering the Operating room, All patients will be monitored using surgical pleth index, arterial blood pressure, pulse oximetry, and electrocardiography. The SPI value will be measured using Datex-Ohmeda (GE Healthcare,Madison,WI 53707-7550 USA) monitoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The group's allocations will be only blinded to assessors, data collectors, and parents of children
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 1-7years.
- •ASA physical status I-II.
- •Hypospadias surgery.
排除标准
- •Children having a history of mental retardation.
- •Developmental delay.
- •Allergic to dexmedetomedine.
- •Neuraxial anesthesia.
- •Cardiovascular disease.
研究组 & 干预措施
Control group
The control group, lactated ringer solution will be infused.
干预措施: Lactated Ringer (Drug)
Control group
The control group, lactated ringer solution will be infused.
干预措施: Hypospadias (Procedure)
Control group
The control group, lactated ringer solution will be infused.
干预措施: Surgical pleth index (Device)
Dexmedetomidine group
In the dexmedetomidine group, dexmedetomidine will be infused.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine group
In the dexmedetomidine group, dexmedetomidine will be infused.
干预措施: Hypospadias (Procedure)
Dexmedetomidine group
In the dexmedetomidine group, dexmedetomidine will be infused.
干预措施: Surgical pleth index (Device)
结局指标
主要结局
Surgical pleth index number
时间窗: 1 minute at end of the operation after skin closure.
from 0 to 100, higher values indicate strong surgical stimulus
次要结局
- Surgical pleth index number(5 minutes after recovery at post anesthesia care unit.)
- Mean arterial blood pressure(1 minute at end of the operation after skin closure.)
- Heart rate(1 minute at end of the operation after skin closure.)
- Need of vasoactive drugs(1minute after infusion until end of surgery)
- FLACC pain score(24 hours after discharge from recovery)
- Ramsay sedation score(2 hours after recovery in postanesthesia care unit)
- Surgical time(1 minute after skin)
- Anesthesia time(5 minutes after insertion of endotracheal tube)
- Total opioid consumption(24 hours after operation)
- Time of 1st analgesia dose(24 hours postoperatively)
- Total non-steroidal consumption(24 hours postoperatively)
- Extubation time(2 minutes after removal of endotracheal tube)
研究者
Mohamed Ahmed Hamed
Associate professor of anesthesia
Fayoum University Hospital