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临床试验/NCT06543134
NCT06543134招募中不适用

Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation

Kocaeli City Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Relationship between hypothermia and emergence agitation

研究概览

简要总结

The main aim of our study was to investigate the relationship between perioperative hypothermia and postoperative emergence agitation.

详细描述

Unintentional hypothermia during surgery is defined as a decrease in body temperature below 36.0 C in the preoperative period, 1 hour before anesthesia and within the first 24 hours after surgery (1).

Unintentional hypothermia during surgery is seen in most patients undergoing surgery. The incidence of perioperative hypothermia is expressed with different values in different studies, but it varies between 30% and 90% (2,3). Hypothermia has many negative effects on mortality and morbidity, such as increased hospital stay, increased perioperative bleeding, increased cardiac complications, delayed wound healing, and delayed recovery from anesthesia (4). It has been observed that these negative effects are seen even in mild hypothermia and that patients should take a more active role in preventing perioperative hypothermia (5). Risk factors for perioperative hypothermia include many factors such as prolonged surgery, advanced age, ASA score, gender, and intravenous fluid administration.

The mentioned negative situation is a negative situation. Recovery agitation was first described in the 1960s and is characterized by restlessness, crying, and poor cooperation (6). Recovery agitation may be severe in the first 30 minutes and then subside. During this time, it may lead to self-harm, disruption of surgical drains or dressings, increased bleeding and surgical complications, unintended early extubations, and an increase in falls and other similar complications in patients (7). Recovery agitation in pediatric patients is measured by the Pediatric Anesthesia Early Delirium Scale and in adult patients, usually by the Richmond Agitation Sedation Scale (8). The incidence of recovery agitation is approximately 20%, and its pathophysiology is not yet fully understood. Risk factors include age, gender, ASA physical status, type of surgery, anesthetic technique (inhalation or total intravenous), administration of neostigmine or doxapram, inadequate postoperative analgesia, pain, presence of a tracheal tube, and presence of a urinary catheter (9). In our literature review, we observed that the effects of perioperative hypothermia and core temperature changes on recovery agitation have not been sufficiently investigated. In this study, we aimed to investigate the relationship between perioperative hypothermia and recovery agitation in patients undergoing septoplasty/rhinoplasty, functional endoscopic sinus surgery (FESS), tympanoplasty, and mastoidectomy in otolaryngology operating rooms.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with informed consent Elective planned cases
  • Patients between the ages of 18-65
  • American Society of Anesthesiologists ASA classification ASA 1-2 patients
  • Surgeries planned to last at least 30 minutes.

排除标准

  • Patients who refuse to participate in the study,
  • patients who are considered for emergency surgery,
  • pediatric patients,
  • patients with peripheral vascular diseases or carotid stenosis,
  • patients using antidepressants or antipsychotic drugs
  • those with neurological diseases will be excluded from the study.

结局指标

主要结局

Relationship between hypothermia and emergence agitation

时间窗: first postoperative hour

Comparison of recovery agitation rates in postoperative hypothermic and non-hypothermic patients

次要结局

  • Incidence of perioperative hypothermia(Between the first 1 hour preoperatively and the first 1 hour postoperatively)

研究者

发起方
Kocaeli City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Aleyna Cicek

Anesthesiologist

Kocaeli City Hospital

研究点 (1)

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