Clinical trial NCT06493396: Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients
Official title: Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid-Free Anesthesia
POCD
Recovery Quality
Sleep Quality
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 88
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 15-item recovery quality scale score 24 hours before surgery
timeFrame: 24 hours before surgery
measure: 15-item recovery quality scale score 24 hours after surgery
timeFrame: 24 hours after surgery
measure: 15-item recovery quality scale score 48 hours after surgery
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index，PSQI
timeFrame: one night before surgery
measure: Pittsburgh Sleep Quality Index，PSQI
timeFrame: first night after surgery
measure: Pittsburgh Sleep Quality Index，PSQI
timeFrame: the second night after surgery
measure: Pittsburgh Sleep Quality Index，PSQI
timeFrame: one week after surgery
measure: Rhodes Index of Nausea and Vomiting
timeFrame: one day before surgery
measure: Rhodes Index of Nausea and Vomiting
timeFrame: 6,24,48 hours after surgery
measure: Ramsay score
timeFrame: 6, 24, 48 hours after surgery
measure: visual analgesia score
timeFrame: 6, 24, 48 hours after surgery
measure: The Mini-Cog cognitive score
timeFrame: first night before surgery
measure: The Mini-Cog cognitive score
timeFrame: first day,second day and one week after surgery
measure: Number of salvage analgesia used within 48 h after surgery
timeFrame: 48 h after surgery
Other outcomes:
Locations:
Study officials:
References: