Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients
- Conditions
- Interventions
- Registration Number
- NCT06493396
- Lead Sponsor
- Beijing Friendship Hospital
- 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...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 88
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Elderly patients to undergo elective non-cardiac surgery
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ASA grade I or III;
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volunteered in this trial and signed informed consent;
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age 60 years;
- BMI 18-30kg / m2.
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Chronic pain;
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severe liver dysfunction (total bilirubin 2 mg dl-1);
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severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
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preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block;
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dementia or significant neurological disease (such as stroke, epilepsy, intracranial tumor, Parkinson disease, etc);
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history of alcohol or drug abuse;
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preoperative or PSQI score 7 or sleep disturbance;
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Cannot cooperate with the scale survey
- Allergic to the trial drug
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Opioid-free group Opioid-free Analgesics - Opioid group Opioid group -
- Primary Outcome Measures
Name Time Method 15-item recovery quality scale score 24 hours before surgery 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...
15-item recovery quality scale score 24 hours after surgery 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...
15-item recovery quality scale score 48 hours after surgery 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...
- Secondary Outcome Measures
Name Time Method The Mini-Cog cognitive score first day,second day and one week after surgery 0 points: 3 words can not remember one, as dementia. 1\~2 points: can remember 1\~2 of 3 words, correct drawing clock test (CDT), normal cognitive function; incorrect CDT, and cognitive function deficit. 3 points: can remember 3 words, not fixed as dementia
Rhodes Index of Nausea and Vomiting 6,24,48 hours after surgery Rhodes Index of Nausea, Vomiting, and Retching, an 8-item questionnaire, to measure the incidence and severity of nausea, vomiting, and retching At each timepoint, a total Rhodes score was calculated from the sum of the 8 RINVR questions. Total Rhodes scores were compared at 6 different timepoints as well as overall across all 6 time points. record Nausea an...
Pittsburgh Sleep Quality Index，PSQI one week after surgery The PSQI scale consists of seven aspects, including time to sleep, hypnotic drugs, sleep time, daytime dysfunction, sleep quality, sleep efficiency, and sleep disorders, with a total score of 0 to 21, which is generally considered in China Score 7 means the presence of sleep disturbance, the higher the score indicates more severe sleep disturbance\]; due to ...
Number of salvage analgesia used within 48 h after surgery 48 h after surgery record number of salvage analgesia used within 48 h after surgery
Ramsay score 6, 24, 48 hours after surgery Total score: 1 to 6,1 indicates insufficient sedation and restlessness; 2 indicates quiet and cooperation; 3 indicates drowsiness and response to commands; 4 indicates shallow sleep and quick response to strong acoustic stimulation; 5 means slow to sleep and response to strong acoustic stimulation; 6 indicates too deep calm and difficult to wake up Score 7 m...
visual analgesia score 6, 24, 48 hours after surgery The total score is 0 to 10,0 indicates no pain, and 10 indicates the most severe play ache