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临床试验/NCT04531371
NCT04531371Unknown1 期

Magnesium Sulphate vs Dexmedetomidine in Prevention of Emergence Agitation in Adults After Nasal Surgeries.

South Valley University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
105
试验地点
1
主要终点
post operative emergence agitation

研究概览

简要总结

Emergence agitation is a postanesthetic phenomenon that develops in the early phase of general anesthesia recovery, and is characterized by agitation, confusion, disorientation, and possible violent behavior. Though agitation is observed more frequently in pediatric patients, the incidence in adults has been reported at 4.7% or 21.3%. Emergence agitation can lead to serious consequences such as self-extubation, removal of catheters, hemorrhage, and even severe injuries from falling out of the bed. Furthermore, it may increase the demand on human resources and cause medical staff injuries.

详细描述

Postoperative agitation (POA) although short-lived is potentially harmful to the patient and the recovery staff. In the postoperative care unit, an agitated patient requires more nurses to control his abnormal movement and apply restrains that could result in bruises of his extremities. In the postoperative care unit, we noticed that agitated patients remove venous and arterial catheters, nasal packs, oxygen masks and endotracheal tubes leading to bleeding and hypoxia.

Post-operative agitation is a well-documented phenomenon in children recovering from sevoflurane anesthesia. However, in adults, few reports have highlighted the occurrence of this phenomenon. The exact trigger for this complication remains to be determined, however, many factors play a crucial role in revealing POA. While an alert, calm patient is the ideal recovery outcome, the occurrence of excitation, excessive motor movements and unexplained sounds is not an uncommon scenario following nasal surgery in adults. Several factors have been incriminated to provoke agitations in adults; pain, hypoxia, type of operation, too rapid emergence from anesthesia, sedatives like benzodiazepines.

Post-operative agitation following nasal surgery The incidence of postoperative agitation following nasal surgery is relatively high. The exact mechanism is Unknown. However, some studies reported that the occurrence of POA could be as high as 55.4% and the presence of nasal pack is likely to be the main trigger of agitation. Other experiments reported an incidence of 68% following nasal surgery. We highlighted several factors that may increase the prevalence of POA; Male gender, young age, smoking, postoperative pain and premedication with atropine and Phenergan. Yu et al., 2005 reported a 55% incidence of POA after nasal surgery. They demonstrated that Doxapram administration, pain, and presence of a tracheal tube and or a urinary catheter appear to be the most important causes of postoperative agitation. Similarly, pain, urinary catheters, and tracheal tubes were also reported by Kim et al., 2004as risk factors for POA following nasal surgery. The presence of nasal pack as a trigger to POA remains debatable.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders
  • Aged 20-40 years.
  • With American Society of Anesthesiologists (ASA) physical status I or II.
  • Nonsmokers.
  • BMI less than or equal to
  • Elective nasal surgery under general anesthesia in which nasal packing on each side was used postoperatively.

排除标准

  • Patients with history of uncontrolled hypertension.
  • Patients with ischemic or valvular heart disease.
  • Patients use MAO inhibitors or adrenergic block.
  • Cognitive impairment.
  • Patients taking antipsychotics.
  • Renal insufficiency or liver impairment.

研究组 & 干预措施

dexemedetomidine

Experimental

dexemedetomidine was administered intravenously after induction of general anesthesia.

干预措施: Dexmedetomidine injection (Drug)

magnesium sulphage

Active Comparator

magnesium sulphate was infused through out the surgery after induction of general anaesthesia.

干预措施: Dexmedetomidine injection (Drug)

saline

Placebo Comparator

nothing was given just saline during the operation.

干预措施: Dexmedetomidine injection (Drug)

结局指标

主要结局

post operative emergence agitation

时间窗: an hour

in post anesthetic recovery unit

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

Ossama Hamdy Salman

clinical professor

South Valley University

研究点 (1)

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