Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients
NCT ID: NCT06362408
Last Updated: 2024-11-04
Study Results
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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COMPLETED
6000 participants
OBSERVATIONAL
2022-06-01
2023-06-01
Brief Summary
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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.
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Detailed Description
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However, it is currently unclear whether choosing DEX during anesthesia has any impact on mortality and mental disorders in older patients undergoing non-cardiac surgery.
Therefore, we utilized prospective research data from 7 centers in China to explore the relationship between intraoperative use of DEX and postoperative 12-month mortality and mental disorders. Propensity score-matching (PSM) and Inverse probability of treatment weighting (IPTW) were conducted, and subgroup analyses were also applied.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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the DEX group
used DEX (safe use range: 0.2\~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery
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.
the Non-DEX group
did not use DEX throughout the entire anesthesia process
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
110 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
The Affiliated Hospital Of Guizhou Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Fudan University
OTHER
Peking University People's Hospital
OTHER
The First Xiangya Hospital of Central South University
UNKNOWN
Second Xiangya Hospital of Central South University
OTHER
China-Japan Friendship Hospital
OTHER
Chinese PLA General Hospital
OTHER
Responsible Party
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Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Principal Investigators
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WEIDONG MI, PhD
Role: STUDY_CHAIR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Hao X, Zhang Z, Yang L, Guo Y, Cao F, Cao J, Liu Y, Lou J, Xu Z, Cui Y, Bai Y, Gu X, Wang D, Cui Q, Zhou Z, Shen H, Sun J, Mi W, Tong L. Association of Dexmedetomidine With Postoperative Depressive Symptoms in Older Surgical Patients: A Prospective Multicenter Study. CNS Neurosci Ther. 2025 May;31(5):e70407. doi: 10.1111/cns.70407.
Other Identifiers
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PLAGH-DEX-PSM/IPTW-001
Identifier Type: -
Identifier Source: org_study_id
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