Clinical Study of Dexmedetomidine Administered Intranasally to Relieve Perioperative Anxiety and Depression in Patients With Colorectal Tumors
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Changes in perioperative HADS scale scores.
研究概览
简要总结
Currently, domestic and international research on dexmedetomidine as well as anxiety and depression is more focused on basic research. In terms of clinical research, dexmedetomidine is more often used in pediatrics, short surgeries, intensive care units, etc., for sedation and analgesia; while less research has been done for the relief of anxiety and depression. At present, on the one hand, the number of oncology patients is on the rise both at home and abroad, and on the other hand, anxiety and depression account for an increasing proportion of healthcare in the world. Tumor patients, as a high prevalence group of anxiety and depression, their prognosis and regression are also more complicated. Therefore, exploring the role of intranasal administration of dexmedetomidine in relieving perioperative anxiety and depression in oncology patients has a very strong practical basis and clinical significance.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a preoperative diagnosis of colorectal cancer who were to undergo their first oncologic procedure
- •Patients who opted for general anesthesia via orotracheal intubation
- •Age ≥18 years old
- •ASA classification II-III (5) 18.0 < BMI < 30.0
- •Signed informed consent.
排除标准
- •Diagnosed mental illness or cognitive impairment, or taking antipsychotic, sedative-hypnotic, or anxiolytic-depressant medications
- •Serious abnormalities of liver or kidney function.
- •Prior alcohol or drug abuse
- •Second or third degree atrioventricular block, severe sinus bradycardia (<50 beats/min), sick sinus node syndrome, congenital heart disease, and other cardiac arrhythmias that severely affect hemodynamic stability
- •Grade 3 hypertension
- •Any disease of the head, such as cerebral infarcts, epilepsy, head trauma, etc.
- •Confirmed diagnosis of non-tumor-induced chronic ( ≥3 months) neuropathic pain
- •Inability to understand the meaning of the scale and complete the scoring.
- •Women preparing for pregnancy, pregnant women, or breastfeeding
- •Patients with myasthenia gravis
- •Respiratory function score ≥3
研究组 & 干预措施
Dexmedetomidine administered intravenously
Dexmedetomidine was administered intravenously 15 min prior to patient induction (concentration 4 μg/ml; loading dose 1 μg/kg for 15 min; maintenance dose: 0.2 μg/(kg.h) until surgical specimen removal).
干预措施: Dexmedetomidine administered intranasally (Drug)
Dexmedetomidine administered intranasally
Intranasal administration of dexmedetomidine (original solution) was given at the bedside of the ward as per the pre-tested recommended dose. The patient's vital signs were maintained. On the day of surgery, 30 min before induction of anesthesia, intranasal dexmedetomidine (original solution) was administered in the operating room at the pre-tested recommended dose.
干预措施: Dexmedetomidine administered intranasally (Drug)
结局指标
主要结局
Changes in perioperative HADS scale scores.
时间窗: The first HADS scale score was performed at preoperative follow-up, and multiple HADS scale scores were performed within 30 days of surgery to observe changes in scores
The first HADS scale score was performed at preoperative follow-up, and multiple HADS scale scores were performed within 30 days of surgery to observe changes in scores.The scale has a minimum score of 0 and a maximum score of 21. Higher scores indicate greater levels of anxiety or depression.
次要结局
未报告次要终点
研究者
Sixu Lai
cinical investigator
First Affiliated Hospital of Chongqing Medical University