Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients

NCT ID: NCT06362408

Last Updated: 2024-11-04

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

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-01

Brief Summary

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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.

Detailed Description

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Studies have suggested that continuous infusion of low-dose DEX during the night after surgery can significantly reduce the incidence of delirium, alleviate pain, and improve subjective sleep quality.

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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Cohort Studies

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

The First Xiangya Hospital of Central South University

UNKNOWN

Sponsor Role collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 40387522 (View on PubMed)

Other Identifiers

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PLAGH-DEX-PSM/IPTW-001

Identifier Type: -

Identifier Source: org_study_id

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