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临床试验/NCT05634148
NCT05634148已完成3 期

Effect of a Single Dose Infusion of Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery - a Randomised Contolled Trial

Security Forces Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年12月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Riker sedation-agitation score

研究概览

简要总结

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

详细描述

Emergence agitation (EA) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. It can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. EA is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality.

There is wide variation in the incidence of EA in scientific literature ranging from 5 % to 27.3 %. There are no clear diagnostic criteria for EA because of its varied clinical manifestations. Although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. Patients undergoing nasal surgeries are in particular, at higher risk for EA due to a sense of suffocation secondary to nasal packing.

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

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
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively

排除标准

  • We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.

研究组 & 干预措施

Dexmedetomidine group

Experimental

Patients in this group will receive intravenous dexmedetomidine before extubation

干预措施: Dexmedetomidine (Drug)

Control group

Placebo Comparator

Patients in this group will receive intravenous placebo (0.9 % saline) before extubation

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Riker sedation-agitation score

时间窗: 60 minutes

Assessment of emergence delirium after extubation. It has numbers from 1-7.

次要结局

  • Postoperative pain score(60 minutes)
  • Opioid consumption(60 minutes)
  • Duration of stay in PACU(60 minutes)
  • Adverse events(60 minutes)

研究者

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

Anwar ul Huda

Principle Investigator

Security Forces Hospital

研究点 (1)

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