The Influence of Sedation Depth Monitoring for Cognitive Functions and Early Rehabilitation After the Elective Total Knee Joints Replacement Surgery in Elderly Patients: Prospective, Randomized, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in cognitive function using Addenbrooke's Cognitive Examination test
研究概览
简要总结
Spinal anesthesia is applied for patients undergoing total elective knee replacement surgery. It reduces rates of postoperative complications, improves postoperative pain management, rehabilitation is started earlier and patients more quickly return to the rhythm of ordinary life. According to the literature data, perioperative stress impacts part of cardiovascular complications and exacerbates postoperative pain. It is important that patients during the surgery under spinal anesthesia prefer to sleep. Thus, in order to reduce perioperative stress, patients during surgery are sedated. It is one of the most effective methods.
On the other hand, deep sedation during surgery versus light sedation, is related to more frequent postoperative cognitive impairment and delirium. It leads to worse later surgery results and worse postoperative quality of life, increased risk of falling, prolonged duration of hospitalization, increased expenses.
详细描述
The aim: To determine value of sedation depth monitoring in order to save patients cognitive functions, to reduce incidence of postoperative delirium and to improve quality of early rehabilitation after the elective total elective knee replacement surgery.
Primary hypothesis: targeted sedation depth monitoring, in order to support light sedation level during the elective knee arthroplasty, helps to save cognitive function and reduce incident of postoperative delirium.
Secondary hypothesis: targeted sedation depth monitoring, in order to support light sedation level, provide better ability to early rehabilitation and patients more quickly return to the rhythm of ordinary life after elective total knee arthroplasty.
Objectives:
- To evaluate moderate and deep sedation rates in a group of patients sedated according to clinical signs only.
- To compare changes in cognitive functions and incidence of delirium after the surgery between a group of patients with light sedation according to bispectral index (BIS) and a group of patients sedated according to clinical signs.
- To assess the impact of sedation depth monitoring for ability and quality of early rehabilitation after elective total knee replacement surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 66 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective total knee replacement surgery under spinal anesthesia with sedation;
- •Age 66 - 90 years;
- •Patients conformed to American Society of Anesthesiologists (ASA) physical status I-II in preoperative assessment;
- •Ability to follow study protocol;
- •Signed agreement to participate in the study.
排除标准
- •Refused elective total knee arthroplasty under spinal anesthesia with sedation;
- •Younger than 66 years;
- •Patients conformed to American Society of Anesthesiologists (ASA) physical status III-IV in preoperative assessment;
- •Patients with mental and central nervous system disorders, which hinder the perception and correct assessment of their condition;
- •Hearing, visual, speech disorders and inability to read, write;
- •Inability to understand and read in Lithuanian language;
- •Refusal to participate in the study.
研究组 & 干预措施
Light sedation according to BIS
Sedation depth will be monitored according to BIS.
干预措施: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) (Device)
Sedation according to clinical signs
Sedation depth will be monitored according to clinical signs using RASS scale, which aim is -3.
干预措施: Dräger Infinity Delta series monitor (Dräger, Germany) with Covidien BIS LoC 2 channel module and BIS Quatro (4 electrodes) sensor (Covidien, Ireland) (Device)
结局指标
主要结局
Changes in cognitive function using Addenbrooke's Cognitive Examination test
时间窗: Before the surgery and first 3 months after elective total knee arthroplasty
次要结局
- Quality of functional recovery using the Quality of Life Questionnaire (SF-36v2 Health Survey)(Before the surgery and first 3 months after elective total knee arthroplasty)
- Rates of moderate and deep sedation according to the BIS in non-interventional group(During the surgery)
- Changes in emotional state according to geriatric depression scale(Before the surgery and first 3 months after elective total knee arthroplasty)
研究者
Inna Jaremko, MD
Principal investigator
Lithuanian University of Health Sciences