The Associations Between Perioperative Depression or Anxiety, Salivary Cortisol and α-amylase, and Administered Anesthesia Type in Knee Arthroscopy With Anterior Cruciate Ligament Reconstruction (ACLR): Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- The changes of Saliva α- amylase activity
研究概览
简要总结
Perioperative depression and/or anxiety play a critical role in patient presentation, satisfaction and outcomes. The aim of this study is to assess the level of perioperative depression and/or anxiety in patients with arthroscopic knee surgery and to evaluate their relationship with anesthesia approach (general anesthesia or non general anesthesia). The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires and the level of salivary cortisol, salivary α-amylase (sAA) and blood glucose.
详细描述
The incidence of perioperative anxiety has been reported to range from 11% to 80% among adult patients. Perioperative depression and/or anxiety may increase the risk of poor postoperative outcomes including increased morbidity and mortality , increased health care utilization, increased opioid consumptions and pain scores, and decreased quality of recovery. Previous studies have found that worrying about postoperative pain, unease of separation from family, loss of selfcare and work ability, fear of surgery and even death are common factors leading to perioperative anxiety symptoms.
The investigators found there were not enough studies to gain insights into the public's knowledges, attitudes, and concerns regarding the risks associated with anesthesia. To some, the fear of general anesthesia (GA) remains prevalent, especially with regard to possible brain damage, death, and intraoperative awareness. The others, neuraxial anesthesia was supposed to result in potentially complications, including postdural puncture headache, backache, transient neurological symptoms, epidural hematoma and abscess, meningitis, arachnoiditis, postoperative urinary retention, local anesthetic systemic toxicity.
Such fears can even exceed the anxiety about actual surgery. Actually, anesthesia approach can be selected based on patients and anesthesiologists preference.
The investigators assumed from clinical experiences that effects of different anesthetic approach and anesthetic drugs on stress reaction, perioperative blood glucose, immunity or neuroendocrine during surgical operation were different, which resulted different prognosis of patients.
The perioperative characteristic of depression or anxiety is assessed by Hospital Anxiety and Depression Scale (HADS) questionnaires, salivary cortisol, salivary α-amylase (sAA) and blood glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Both the investigator and the outcomes assessor doing follow-up interviews and extracting data from the electronic medical records will be blinded to group allocation and treatment interventions. The patients know the allocation, cause patients in group NGA will not receive any sedation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be scheduled to receive anterior cruciate ligament reconstruction of knee joint for the first time
- •American Society of Anesthesiologists (ASA) physical status I or II
- •The operation time is less than 2 hours (from the beginning use of the tourniquet to the release)
排除标准
- •Clinical diagnosis of anxiety or depression or mania
- •Clinical diagnosis of systemic diseases (systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, primary aldosteronism, Cushing syndrome)
- •Medication history of cortisol or sedative hypnotic drugs
- •Tumor patients
- •Pregnancy status
- •Drinking coffee or alcohol drinks during perioperative period
结局指标
主要结局
The changes of Saliva α- amylase activity
时间窗: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Enzymatic assay for the determination of alpha amylase activity in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.
The rate of Depression symptoms (HADS-D)
时间窗: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital
The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression. The score for each individual item could vary from 0 to 3, so that the total score for each scale about depression (HADS-D) ranges from 0 to 21. If the score was 0-7, indicating that there was no depression; the score was 8-10, suspected depression; 11-14, moderate depression; the score was 15-21, severe depression. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.
The rate of Anxiety symptoms (HADS-A)
时间窗: one day before surgery, 1day, 3 days after surgery and 5 days after surgery while in hospital
The HADS scale includes two dimensions of anxiety and depression, with a total of 14 items, 7 items for anxiety and 7 items for depression. The score for each individual item could vary from 0 to 3, so that the total score for each scale about anxiety (HADS-A) ranges from 0 to 21. If the score was 0-7, indicating that there was no anxiety; the score was 8-10, suspected anxiety; 11-14, moderate anxiety; the score was 15-21, severe anxiety. If the score is ≥ 8, it will be rated as positive, otherwise it will be rated as negative.
The changes of salivary cortisol concentration
时间窗: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Enzyme immunoassay for the quantitative determination of free Cortisol in human saliva.The patient should not eat, drink, chew gums or brush teeth for 30 min before sampling.Otherwise rinse mouth thoroughly with cold water 5 min prior to sample collection.A minimum of 0.5 mL liquid should be collected. Saliva flow can be stimulated by chewing on a piece of Parafilm.
The changes of Blood glucose level
时间窗: on the day of surgery (6 - 8 am), at 2 hours after surgery, the first morning after surgery (6 - 8 am) and the second morning after surgery (6 - 8 am)
Using a glucose meter to check and monitor blood sugar via finger stick
次要结局
- Complications related to combined spinal-epidural anesthesia(started from the beginning of combined spinal-epidural anesthesia to the first 72 post-operative hours)
- The changes of swelling rating(at 6, 12, 24, 48, and 72 hours after surgery)
- Post-operative opioid consumptions(from arrived at PACU to the first 72 post-operative hours)
- Complications related to general anesthesia(started from the induction of general anesthesia to the first 72 post-operative hours)
- The changes of skin temperature rating(at 1, 3, and 5 days after surgery)
- Length of hospital stay(The length of hospital stay was counted in days, about 5 to 7 days usually)
- The changes of NRS of postoperative pain(at 2, 6, 12, 24, 48, and 72 hours after surgery)
- Complications related to femoral nerve block(started from the puncture of nerve block to the first 72 post-operative hours)
- Costs of hospitalization(through study completion, an average of 1 week)
研究者
Congcong Huang
Principal Investigator
Second Affiliated Hospital of Wenzhou Medical University