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

NCT06362408 | Completed

• 1 other identifier: PLAGH-DEX-PSM/IPTW-001
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cohort Studies

Keywords

Dexmedetomidine; Postoperative mental disorders; Long-term survival; Elderly patients; depression; anxiety; delirium

Outcome Measures

Primary Outcomes (1)

• Postoperative mortality rate

  the 12-month all-cause mortality

  up to 12 month

Secondary Outcomes (6)

• The incidence of postoperative delirium

  During hospitalization (up to 1 month)

• The incidence of postoperative anxiety

  Anxiety within 7 days of surgery

• The incidence of postoperative depression

  Depression within 7 days of surgery

• Postoperative sleep disorders

  within 6 months after surgery

• Surgical related complications

  within 12 months after surgery

Study Arms (2)

the DEX group

used DEX (safe use range: 0.2\~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery

Drug: Dexmedetomidine

the Non-DEX group

did not use DEX throughout the entire anesthesia process

Interventions

Dexmedetomidine 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 DEX group

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older patients (≥ 65 years) who underwent elective major non-cardiac surgery were considered to be initially eligible. Non-cardiac surgery departments included otolaryngology surgery, urinary surgery, gynecology, gastrointestinal surgery, orthopedic surgery, thoracic surgery and hepato-pancreato-biliary surgery.

You may qualify if:

• Age ≥65 years old, regardless of gender
• Patients undergoing general anaesthesia (combined sedation or intravenous general anaesthesia)
• ASA level 1-3
• Patients undergoing elective non-cardiac surgery, non-neurosurgery

You may not qualify if:

• More than 20% missing data for covariates;
• Postoperative admission to the intensive care unit (ICU) or death during follow-up;
• Preoperative history of severe sleep disorder and taking related medication;
• Have a history of severe anxiety or depression prior to surgery and taking relevant medication;
• Severe hearing, speech and cognitive impairments that preclude access to follow-up visits

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Fudan University: collaborator
• Peking University People's Hospital: collaborator
• The First Xiangya Hospital of Central South University: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 40387522 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• WEIDONG MI, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: June 1, 2022
• Primary Completion: May 25, 2023
• Study Completion: June 1, 2023
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)