Effect of Dexmedetomidine on Recovery Profiles of Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recovery time (1)
研究概览
简要总结
Emergence of elderly patients from anesthesia may face with cognitive dysfunction or agitation such as delirium. There are reports that using dexmedetomidine as a adjuvant for general anesthesia decreased emergence-agitation in children and dexmedetomidine may be used for treating deliriums. Thus, we thought that dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly.
The aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.
详细描述
Purpose: The aims of this study were to investigate the recovery characteristics (time to recovery of consciousness (ROC) and recovery, bispectral index (BIS) values at ROC and orientation, and Ricker sedation-agitated scale at the postanesthetic care unit) and safety (vital signs during and after administration of dexmedetomidine) of dexmedetomidine in elderly patients undergoing elective surgery.
Hypothesis: Dexmedetomidine as a adjuvant agent may be a help to smooth emergence from anesthesia in elderly.
Objectives: Patients who are scheduled to undergo elective surgery, American society of anesthesiologist class (ASA) I-II, aged over 65 years, are randomly allocated into six groups.
- Group 1: general anesthesia with sevoflurane only (placebo: normal saline)
- Group 2: general anesthesia with propofol and remifentanil (total intravenous anesthesia) only (placebo: normal saline)
- Group 3: general anesthesia with sevoflurane and adjuvant dexmedetomidine
- Group 4: general anesthesia with propofol and remifentanil (total intravenous anesthesia), and adjuvant dexmedetomidine
Research Method: Once in the operating room, patients were monitored with electrocardiography, non invasive blood pressure, pulse oximetry (Datex-Ohmeda S/5, Planar Systems, Inc., Beaverton, OR, USA) and BIS (Aspect 2000, Aspect Medical Systems, Inc., Newton, MA, USA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 65
- •Elective surgery
排除标准
- •Patients with severe heart disease with New York Heart Association class > III
- •Patients with severe arrhythmia
- •Patients with uncontrolled hypertension or hypotension
- •Patients with hemodynamic unstably
- •Patients with hypersensitivity with drugs
- •Patients with cognitive deficiency, dementia, or delirium
- •Patients with hepatic or renal compromise
- •Patients with infective disease
研究组 & 干预措施
Group 1
General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Sevoflurane (Drug)
Group 1
General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Normal saline (Drug)
Group 1
General anesthesia with sevoflurane. Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Rocuronium (Drug)
Group 2
General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Propofol and Remifentanil (Drug)
Group 2
General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Normal saline (Drug)
Group 2
General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of normal saline during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Rocuronium (Drug)
Group 3
General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Dexmedetomidine (Drug)
Group 3
General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Sevoflurane (Drug)
Group 3
General anesthesia with sevoflurane. Infusion of dexmedetomidine (0.4 ug/kg/hr) during anesthesia. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Rocuronium (Drug)
Group 4
General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of dexmedetomidine (0.4 ug/kg/hr) during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Dexmedetomidine (Drug)
Group 4
General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of dexmedetomidine (0.4 ug/kg/hr) during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Propofol and Remifentanil (Drug)
Group 4
General anesthesia with propofol and remifentanil. (Total intravenous anesthesia) Infusion of dexmedetomidine (0.4 ug/kg/hr) during surgery. Administer rocuronium 0.8 mg/kg for induction.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Recovery time (1)
时间窗: At the end of surgery and anesthesia, an expected average of 15 minutes
Time to eye opening.
次要结局
- Ricker scale(About 5 minutes after end of surgery and anesthesia)
研究者
Ki Tae Jung
Assist Professor, Principal Investigator, Clinical Professor of Department of Anesthesiology and Pain medicine, School of Medicine, Chosun University
Chosun University Hospital