Dexmedetomidine and 5-year Outcome in Elderly Patients After Surgery
NCT ID: NCT03436472
Last Updated: 2019-06-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
700 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-06-01
Study Completion Date
2019-04-01
Brief Summary
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Delirium is a frequent postoperative complication. Its occurrence is associated with worse long-term outcomes. In a previous randomized controlled trial, prophylactic low-dose dexmedetomidine infusion during the early postoperative period decreased the incidence of delirium in elderly patients after surgery. The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.
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Detailed Description
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Delirium is a frequent postoperative complication; a systematic review revealed that postoperative delirium occurs in 36.8% of surgical patients, and its prevalence increases with age. The occurrence of delirium is associated with worse long-term outcomes including worse functional recovery, decline in cognitive function, and increased mortality rate. Surgical stress, pain, and sleep disturbances are important factors leading to postoperative delirium in the elderly.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia.
In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo \[normal saline\] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% \[79/350\] with placebo vs. 9.1% \[32/350\] with dexmedetomidine; odds ratio 0.35, 95% confidence interval 0.22 to 0.54; p \< 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population.
The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist that provides anti-anxiety, sedation, and modest analgesia with minimal respiratory depression. For mechanically ventilated intensive care unit (ICU) patients, dexmedetomidine sedation improves the quality of sleep, decreases the incidence of delirium, and shortens the duration of ICU stay. For patients undergoing surgery, perioperative dexmedetomidine relieves the severity of stress response, decreases the requirement of anesthetics, and improves postoperative analgesia.
In the previous stage of the current study, 700 elderly patients who were admitted to the ICU after noncardiac surgery were recruited and randomized into two groups (dexmedetomidine group and placebo \[normal saline\] group). The results showed that prophylactic low-dose dexmedetomidine infusion during the early postoperative period ameliorated the subjective sleep quality and decreased the incidence of delirium (22.6% \[79/350\] with placebo vs. 9.1% \[32/350\] with dexmedetomidine; odds ratio 0.35, 95% confidence interval 0.22 to 0.54; p \< 0.0001). The investigators hypothesize that low-dose dexmedetomidine infusion may also improve long-term outcome in this patient population.
The purpose of this 5-year follow-up study is to evaluate whether prophylactic low-dose dexmedetomidine infusion during the early postoperative period can improve the 5-year outcomes in elderly patients recruited in the previous randomized controlled trial.
Conditions
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Aged
Operative
Delirium
Dexmedetomidine
Mortality
Long-term Survivors
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel Assignment
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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dexmedetomidine group
For patients who were not intubated, dexmedetomidine was infused at a rate of 0.1 microgram/kg per hour from study recruitment on the day of surgery until 8:00 am on the first day after surgery. For patients who were intubated and mechanically ventilated, dexmedetomidine infusion was started after the Richmond Agitation Sedation Scale was -2 or higher after intensive care unit admission until 8:00 am on the first day after surgery.
Group Type
EXPERIMENTAL
dexmedetomidine
Intervention Type
DRUG
low-dose dexmedetomidine infusion
placebo group
Normal saline was infused in the same rate for the same duration as that in the placebo group.
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
DRUG
normal saline infusion
Interventions
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dexmedetomidine
low-dose dexmedetomidine infusion
Intervention Type
DRUG
placebo
normal saline infusion
Intervention Type
DRUG
Other Intervention Names
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dexmedetomidine hydrochloride
normal saline
0.9% sodium chloride
Eligibility Criteria
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Inclusion Criteria
Patients were included if they met all of the following criteria:
* Age of 65 years or older;
* Underwent elective noncardiac surgery under general anesthesia;
* Admitted to ICU after surgery.
* Age of 65 years or older;
* Underwent elective noncardiac surgery under general anesthesia;
* Admitted to ICU after surgery.
Exclusion Criteria
Patients were excluded if they met any of the following criteria:
* Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
* Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
* Brain injury or neurosurgery;
* Preoperative left ventricular ejection fraction \< 30%, sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or greater atrioventricular block without pacemaker;
* Serious hepatic dysfunction (Child-Pugh class C);
* Serious renal dysfunction (undergoing dialysis before surgery); or
* Unlikely to survive for more than 24 hours.
* Preoperative history of schizophrenia, epilepsy, Parkinsonism or myasthenia gravis;
* Inability to communicate in the preoperative period (because of coma, profound dementia or language barrier);
* Brain injury or neurosurgery;
* Preoperative left ventricular ejection fraction \< 30%, sick sinus syndrome, severe sinus bradycardia (\< 50 beats per minute), or second-degree or greater atrioventricular block without pacemaker;
* Serious hepatic dysfunction (Child-Pugh class C);
* Serious renal dysfunction (undergoing dialysis before surgery); or
* Unlikely to survive for more than 24 hours.
Minimum Eligible Age
65 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Peking University Third Hospital
OTHER
Sponsor Role
collaborator
Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, , China
Site Status
Countries
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China
References
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Reference Type
BACKGROUND
Other Identifiers
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Dex-5-2016
Identifier Type: -
Identifier Source: org_study_id
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