Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Effect of Intraoperative Use of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients Undergoing Non-cardiac Surgery

ID
Name
PLAGH-DEX-PSM/IPTW-001
Description
China's aging population is causing an increase in the number of senior persons undergoing surgery. More and more clinicians are paying attention to the postoperative survival and mental health of elderly surgical patients. Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. DEX has the potential to prevent and treat postoperative anxiety and depression in elderly patients undergoing non-cardiac surgery. Further exploration of evidence for evidence-based medicine is needed. Based on the above research background, this hypothesis is proposed: in elderly patients undergoing noncardiac surgery, intraoperative DEX is associated with a reduction in short-term postoperative mental disorders and a reduction in long-term postoperative mortality.
Trial arms
Trial start
2022-06-01
Estimated PCD
2023-05-25
Trial end
2023-06-01
Status
Completed
Treatment
Dexmedetomidine
Older patients who have used dexmedetomidine(safe use range: 0.2\~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery were classified as the DEX group. On the contrary, patients who did not use dexmedetomidine throughout the entire anesthesia process were identified as the Non-DEX group.
Arms:
the DEX group
Size
6000
Primary endpoint
Postoperative mortality rate
up to 12 month
Eligibility criteria
Inclusion Criteria: 1. Age ≥65 years old, regardless of gender 2. Patients undergoing general anaesthesia (combined sedation or intravenous general anaesthesia) 3. ASA level 1-3 4. Patients undergoing elective non-cardiac surgery, non-neurosurgery Exclusion Criteria: 1. More than 20% missing data for covariates; 2. Postoperative admission to the intensive care unit (ICU) or death during follow-up; 3. Preoperative history of severe sleep disorder and taking related medication; 4. Have a history of severe anxiety or depression prior to surgery and taking relevant medication; 5. Severe hearing, speech and cognitive impairments that preclude access to follow-up visits
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 6000, 'type': 'ACTUAL'}}
Updated at
2024-04-12

1 organization

1 product

1 indication

Organization
Chinese PLA General Hospital
Product
Dexmedetomidine
Indication
Cohort Studies