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临床试验/NCT06493396
NCT06493396尚未招募不适用

Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients

Beijing Friendship Hospital0 个研究点目标入组 88 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
88
主要终点
15-item recovery quality scale score 24 hours before surgery

研究概览

简要总结

Postoperative cognitive dysfunction (POCD)is a common well disorder of the central nervous system after surgery, mainly manifested by impaired memory, spirit, language ability or other aspects of brain function. POCD, which often occurs in elderly patients over 65 years, The recent phase is recommended to be changed to perioperative neurocognitive impairment ( PND), The PND is used to describe the cognitive function changes that occur before and within 1 year after surgery, Based on the time of disease onset, It can be divided into neurocognitive impairment existing before surgery, postoperative delusion (POD) occurring hours to days after surgery, neurocognitive recovery delay (DNR) within 30 days after surgery, and postoperative neurocognitive impairment occurring weeks to months after surgery (POND). With the acceleration of the aging process of Chinese social population, the frequency of surgical treatment for elderly inpatients has also increased, and the elderly patients have postoperative sleep disorders, and POCD is relatively common. Surgical patients after surgical trauma, the body inflammation, sympathetic excitation and endocrine disorders, make postoperative sleep structure or pattern change, often lead to postoperative sleep disorders (PSD) , the main performance for patients with postoperative complaint difficult to enter and maintain sleep, frequent nightmares, total sleep quantity and quality reduction, etc. PSD is not only the most common manifestation of postoperative brain dysfunction, but also an important risk factor for inducing postoperative fatigue, postoperative hyperalgesia, metabolic dysfunction, and cardiovascular and cerebrovascular diseases. Moreover, it is considered to promote the development of postoperative delusion. At present, the common mode of general anesthesia is still mainly opioids, and opioids are an important part of general anesthesia and perioperative analgesia. Perioperative use of opioids is not only associated with adverse effects such as postoperative nausea and vomiting, excessive sedation, and ileus, but also leads to the occurrence of postoperative hypoxemia, hyperalgesia and postoperative chronic pain, and cognitive impairment. Therefore, the Association of Accelerated Rehabilitation Surgery indicates that the use of a multimodal analgesic regimen during the perioperative period reduces pain and reduces opioid-related adverse effects, and that opioid-free anesthesia ( OFA) is used in clinical work. At present, most clinical studies of OFA focus on adults aged 18-65 or 18 years old, and few studies focus OFA solely on the elderly population to observe its application effect. Therefore, it is necessary to conduct clinical studies to observe postoperative recovery in elderly patients with different types of anesthetics, investigate the incidence and severity of POCD, and determine the efficacy and safety of each anesthetic agent.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patients to undergo elective non-cardiac surgery
  • ASA grade I or III;
  • volunteered in this trial and signed informed consent;
  • age 60 years;
  • BMI 18-30kg / m2.

排除标准

  • Chronic pain;
  • severe liver dysfunction (total bilirubin 2 mg dl-1);
  • severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
  • preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block;
  • dementia or significant neurological disease (such as stroke, epilepsy, intracranial tumor, Parkinson disease, etc);
  • history of alcohol or drug abuse;
  • preoperative or PSQI score 7 or sleep disturbance;
  • Cannot cooperate with the scale survey
  • Allergic to the trial drug

研究组 & 干预措施

Opioid-free group

Experimental

干预措施: Opioid-free Analgesics (Drug)

Opioid group

Active Comparator

干预措施: Opioid group (Drug)

结局指标

主要结局

15-item recovery quality scale score 24 hours before surgery

时间窗: 24 hours before surgery

The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

15-item recovery quality scale score 24 hours after surgery

时间窗: 24 hours after surgery

The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

15-item recovery quality scale score 48 hours after surgery

时间窗: 48 hours after surgery

The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

次要结局

  • The Mini-Cog cognitive score(first day,second day and one week after surgery)
  • Rhodes Index of Nausea and Vomiting(6,24,48 hours after surgery)
  • Number of salvage analgesia used within 48 h after surgery(48 h after surgery)
  • Pittsburgh Sleep Quality Index,PSQI(one week after surgery)
  • Ramsay score(6, 24, 48 hours after surgery)
  • visual analgesia score(6, 24, 48 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bijia Song

principal investigator

Beijing Friendship Hospital

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