Surgery Clinical Trial
Official title:
Impact of Dexmedetomidine Supplemented Analgesia on Sleep Quality in Elderly Patients After Major Surgery: A Randomized, Double-blind, and Placebo-controlled Pilot Study
Verified date | February 2021 |
Source | Peking University First Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sleep disturbances frequently occur in elderly patients after major surgery; and their occurrence are associated with worse outcomes including increased incidence of delirium. Previous studies showed that, for elderly patients admitted to the ICU after non-cardiac surgery, low-dose dexmedetomidine infusion improved to some degree the quality of sleep and reduced the incidence of delirium. The investigators hypothesize that, for elderly patients after major non-cardiac surgery, dexmedetomidine supplemented analgesia can also improve the sleep quality. The purpose of this randomized controlled pilot study is to investigate the impact of dexmedetomidine supplemented analgesia on the sleep quality in elderly patients after major non-cardiac surgery.
Status | Completed |
Enrollment | 118 |
Est. completion date | February 18, 2020 |
Est. primary completion date | January 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Age >= 65 years 2. Scheduled to undergo elective non-cardiac major surgery (with expected duration >= 2 hours) under general anesthesia 3. Transferred to general ward with a patient-controlled intravenous analgesia pump after surgery. Exclusion Criteria: 1. Refuse to participate 2. Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis 3. Patients with preoperative sleep disorders (accepted sedatives or hypnotics within 1 month before surgery) or the STOP-BANG Questionnaire score is 3 or higher 4. Inability to communicate in the preoperative period because of coma, profound dementia or language barrier 5. Brain injury or neurosurgery 6. Preoperative left ventricular ejection fraction < 30%, sick sinus syndrome, severe sinus bradycardia (< 50 beats per minute), or second-degree or above atrioventricular block without pacemaker 7. Severe hepatic dysfunction (Child-Pugh class C); Severe renal dysfunction (requirement of renal replacement therapy before surgery); ASA classification IV or unlikely to survive for more than 24 hours after surgery 8. Patients recruited in other studies 9. Other conditions that are considered unsuitable for study participation |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
China,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain intensity | Estimated with numeric rating scale, where 0 = no pain and 10 the most severe pain | Up to the fifth day after surgery | |
Other | Subjective sleep quality | Estimated with numeric rating scale, where 0 = the best sleep and 10 the worst sleep. | Up to the fifth day after surgery | |
Other | Sedation level | Assessed using the Richmond Agitation-Sedation Scale (RASS), with scores ranging from -5 (unarousable) to +4 (combative) and 0 indicates alert and calm. | Up to the fifth day after surgery | |
Other | Cumulative consumption of morphine | Cumulative morphine consumption after surgery | Up to the fifth day after surgery | |
Other | Incidence of delirium | Incidence of delirium within 5 days after surgery | During the first 5 days after surgery | |
Other | Length of stay in hospital after surgery | Length of stay in hospital after surgery | Up to 30 days after surgery | |
Other | Incidence of postoperative complications | Incidence of non-delirium complications within 30 days after surgery | Up 30 days after surgery | |
Other | 30-day mortality | All cause mortality on the 30th day after surgery | On the 30th day after surgery | |
Other | Quality of life | Quality of life is assessed with the World Health Organization Quality of Life-brief version (WHOQOL-BREF; a 24-item questionnaire that provides assessments of the quality of life in 4 domains. The score of each domain ranges from 0 to 100, with higher score indicating better function). | On the 30th day after surgery | |
Other | Cognitive function | Cognitive function is assessed with the Telephone Interview for Cognitive Status-modified (TICS-m; score ranges from 0 to 50, with higher score indicating better function). | On the 30th day after surgery | |
Primary | The percentage of stage N2 sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The duration of stage N1 sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The percentage of stage N1 sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The duration of stage N2 sleep | Determined by polysomnographic monitoring | During the night after surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The duration of stage N3 sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The percentage of stage N3 sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The duration of REM sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | The percentage of REM sleep | Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | Total sleep time | Total time spent in any sleep stage during the monitoring period. Determined by polysomnographic monitoring. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | Sleep efficiency | The ratio between the total sleep time and the total recording time and expressed as percentage. Determined by polysomnographic monitoring. | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) | |
Secondary | Sleep fragmentation index | The average number of arousals and awakenings per hour of sleep. Determined by polysomnographic monitoring | During the night of surgery (from 9 pm on the day of surgery to 6 am on the first day after surgery) |
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