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临床试验/NCT06218173
NCT06218173已完成不适用

Clinical Impact of Local Anaesthetic Timing on Sedation Stability and Propofol Dosage in Paediatric Dental Sedation

Ankara University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Estimate the effect of local anesthesia on hemodynamic parameters

研究概览

简要总结

The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures.

The main questions it aims to answer are:

  • Impact of local anesthesia on sedation depth and hemodynamic parameters
  • Impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation.

Participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued.

If there is a comparison group:

详细描述

Local anaesthesia (LA) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of LA administration during sedation is varies according to personal preferences of dentists. Aim of this retrospective study is to investigate the effects of the timing of LA on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures.

Records of healthy children who were sedated for dental restorations will be divided into two groups. Patients who received LA at the beginning of sedation or who received LA at the end of sedation after completion of restorations. It is planned to compare the patient groups in terms of demographic data, hemodynamic data, BIS scores, Ramsey Sedation Scale scores, total propofol dose administered.

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 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. Patients with an American Society of Anesthesiologist (ASA) physical status classification of I-II and aged between 2 and 8 years were included in the study.

排除标准

  • Exclusion criteria were ASA status III-V, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.

结局指标

主要结局

Estimate the effect of local anesthesia on hemodynamic parameters

时间窗: 1 year

Estimate the effect of local anesthesia on total propofol requirement

时间窗: 1 year

Estimate the effect of local anesthesia on sedation depth

时间窗: 1 year

次要结局

未报告次要终点

研究者

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

Cagil Vural

Assoc. Prof.

Ankara University

研究点 (1)

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