Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Incidence of anxiety at one day after surgery
研究概览
简要总结
To investigate the effect of different doses of dexmedetomidine on Cerebral Oxygen Saturation and Postoperative anxiety in elderly patients undergoing laparoscopic surgery
详细描述
A total of 105 patients who were admitted to The First Hospital of Qinhuangdao for laparoscopic surgery and divided into control group (group C), dexmedetomidine doses of 0.2 μg/kg (group D1), dexmedetomidine doses of 0.5 μg/kg (group D2).
105 patients were randomized equally into 3 groups. 35 cases in each group. Group C received general anesthesia without dexmedetomidine, groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine, groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine.SBP(Systolic Blood Pressure),DP(Diastolic Pressure),HR(Heart Rate) and rScO2(Regional cerebral oxygen saturation) of the three groups were recorded before anesthesia induction (T1), at the time of intubation (T2), five minutes after induction(T3),at the beginning of surgery (T4), immediately after surgery (T5), and five minutes after extubation (T6).
The cognitive function of the three groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of the three groups was assessed with Self-rating Anxiety Scale (SAS) on the day before surgery,one day after and three days after surgery, comparing the incidence of anxiety between the three groups. Analyze whether dexmedetomidine reduced the incidence of anxiety by increasing cerebral oxygen saturation.
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, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 65 years or older who underwent elective laparoscopic surgery under general anesthesia
- •BMI less than 30 kg/m2
- •American Society of Anesthesiologists (ASA) grades I-III
- •The score of Mini Mental state examination≥24
排除标准
- •Patients with heart, lung and other vital organ disorders
- •The score of Mini Mental state examination≤23
- •Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system
- •Have severe visual, hearing, speech impairment or other inability to communicate with the visitor
- •Refuse to sign informed consent
- •known preoperative left ventricular ejection fraction less than 30%, sick sinus syndrome, severe sinus bradycardia (<50 beats per min [bpm]), or second-degree or greater atrioventricular block without pacemaker
研究组 & 干预措施
Group C
Group C received general anesthesia with intravenous normal saline. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.
干预措施: normal saline (Drug)
Group D1
groups D1 received general anesthesia with intravenous pump of 0. 2μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.
干预措施: Dexmedetomidine (Drug)
Group D2
groups D2 received general anesthesia with intravenous pump of 0. 5μg/kg/h dexmedetomidine. The cognitive function of this groups was assessed with the Mini Mental State Scale (MMSE) on the day before surgery. the anxiety of this groups was assessed with Self-rating Anxiety Scale (SAS) on the day before, one day after and three days after surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of anxiety at one day after surgery
时间窗: One day after surgery
The three groups of patients were scored on the Self-rating Anxiety Scale on the first day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the first day after surgery in the three groups was statistically significant.
Incidence of anxiety at three days after surgery
时间窗: Three days after surgery
The three groups of patients were scored on the Self-rating Anxiety Scale on the third day after surgery, and if the Self-rating Anxiety Scale score was ≥ 50 points, the patients developed anxiety, and whether the incidence of anxiety on the third day after surgery in the three groups was statistically significant.
次要结局
- Anesthetic drug(Time Frame: during the surgery)
- The change of SBP(before anesthesia induction, at the time of intubation, at the beginning of surgery, immediately after surgery , and five minutes after extubation)
- The change of rScO2(during the surgery)