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预防性静脉微剂量右美托咪定用于预防接受鼻中隔成形术成年患者苏醒期躁动

2026年10月5日 更新者:Mai Salah Salem、Tanta University

预防性静脉微剂量右美托咪定预防成人鼻中隔成形术患者苏醒期躁动:一项随机安慰剂对照研究

This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries

研究概览

地位

完全的

条件

详细说明

Emergence agitation (EA) is characterised by confusion, restlessness or aggressive behaviour during recovery from general anaesthesia. EA is more common following ear, nose, & throat (ENT) surgery. The exact cause and pathophysiology of EA are unknown, although risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, otolaryngology operations, and the use of inhalational anesthetics particularly sevoflurane. EA might cause injury, accidental removal of intravenous cannulation, self-extubation, post-operative wound bleeding and increase the nursing requirements in the post-anesthesia care unit (PACU). There are limited studies concerning adult EA, and although its prevalence is less than child EA, it carries more risk of injury due to serious uncontrolled behaviors. Intravenous (IV) anesthetics, sedatives and opioids are the most frequently utilized medications to manage EA, with variable success rates and significant potential to delay recovery and cause undesirable side-effects. Dexmedetomidine is a highly selective α2 agonist which produces sedation and anxiolysis through reduction in sympathetic central nervous system activity. It has a major advantage over other sedatives; it is associated with minimal respiratory depression. According to a recent meta-analysis, intraoperative administration of dexmedetomidine decreases postoperative pain and the incidence of EA in adults. Considering the short length of corrective nasal reduction surgery (CR), an intraoperative infusion of dexmedetomidine as an anesthetic adjuvant may prolong the anesthesia and recovery time. Low dose infusion of dexmedetomidine (0.2 µg /kg/h) has been reported to reduce incidence of EA and opioid consumption effectively in elderly patients undergoing cancer surgeries under GA. Previous studies have shown that a single dose of dexmedetomidine, not as a premedication, is also effective in reducing EA and facilitating smooth extubation after pediatric adenotonsillectomy. Also recent study reported the efficacy of pre-operative dexmedetomidine administration (1 μg/kg) in preventing EA in adults undergoing CR of a nasal bone fracture. Up till now no clinical studies investigated the efficacy of single pre-operative micro dose of dexmedetomidine in prevention of EA, so in this clinical study we hypothesize that preoperative micro dose of dexmedetomidine may be beneficial in mitigation of EA in short timed Septoplasty surgeries safely and without prolongation of recovery time.

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Gharbia Governorate
      • Tanta、Gharbia Governorate、埃及、31527
        • Tanta university

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult patients of both gender aged 18 to 60 years with American Society of Anesthesiologists (ASA) Physical Status I or II, who were scheduled for septoplasty surgery under general anesthesia.

Exclusion Criteria:

  • Patients declined to participate in the trial.
  • History or clinical evidence of chronic obstructive pulmonary disease.
  • History of renal or hepatic dysfunction, sleep apnea syndrome.
  • Cognitive dysfunction or psychiatric disorder.
  • Patients receiving beta blocker.
  • Patients with anticipated difficult airway.
  • Patients with electro cardiac abnormalities.
  • Emergency surgeries.
  • Pregnancy.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Dexmedetomidine group

60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

安慰剂比较:Control group

60 patients will receive preoperative micro dose of dexmedetomidine (0.3 µg /kg) in 50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

50 ml 0.9% saline slow infusion over 10 minutes, 15 minutes before surgery.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of emergence agitation
大体时间:incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

using Aono's Four-Point Scale (Aono Scale) which is a simple and widely used tool to assess emergence agitation (EA). It categorizes agitation during emergence from anesthesia into four levels.

  1. calm_ Patient is quiet and not agitated.
  2. Not calm but can be easily consoled _ Slight restlessness but settles with verbal reassurance or mild physical comfort.
  3. Moderately agitated _ Patient is crying or difficult to console but not combative.
  4. Severely agitated _Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

Scores 3-4 indicate clinically relevant emergence agitation.

incidence of emergence agitation will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

次要结果测量

结果测量
措施说明
大体时间
severity of emergence agitation
大体时间:severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.

Aono's Scale grades the intensity of a patient's agitation during emergence from anesthesia (3) Moderately agitated - Patient is crying or difficult to console but not combative.

(4) Severely agitated - Patient is thrashing, inconsolable, or combative, and poses risk of injury to self or staff.

severity of EA will be assessed by Aono's Four-point Scale (AFPS) after extubation, at PACU arrival, every 5 minutes for the first 15 minutes then every 15 minutes for the first hour after surgery.
extubation time
大体时间:Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).

Extubation time is the duration between the cessation of anesthetic agents and removal of endotracheal tube (ETT).
Length of stay in the post anesthetic care unit (PACU).
大体时间:time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

Total time a patient spends in the PACU from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward

time from the moment they arrive after surgery until they meet discharge criteria and are officially transferred to the ward
Intraoperative opioid consumption
大体时间:from induction of anesthesia until completion of surgery

Total amount of opioid medications administered to a patient during the entire surgical procedure, from induction of anesthesia until completion of surgery

from induction of anesthesia until completion of surgery
Post operative numerical rating scale score (NRS)
大体时间:- NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

The Numerical Rating Scale (NRS) is a validated tool used to assess a patient's pain intensity by having them assign a number to their pain on a 0-10 scale.

On a scale from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable

- NRS score is measured at PACU arrival and every 15 minutes for 1 hour after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月10日

初级完成 (实际的)

2026年8月20日

研究完成 (实际的)

2026年8月20日

研究注册日期

首次提交

2025年12月11日

首先提交符合 QC 标准的

2025年12月11日

首次发布 (实际的)

2025年12月24日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月5日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

The data will be available upon a reasonable request from the corresponding author

IPD 共享时间框架

The data will be available upon a reasonable request from the corresponding author after the end of the study for one year

IPD 共享访问标准

The data will be available upon a reasonable request from the corresponding author

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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