Clinical trial NCT06362408: Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients
Official title: Effect of Intraoperative Use of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients Undergoing Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cohort Studies
Keywords: Dexmedetomidine
Postoperative mental disorders
Long-term survival
Elderly patients
depression
anxiety
delirium
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Wuhan Union Hospital, China
name: Fudan University
name: Peking University People's Hospital
name: The First Xiangya Hospital of Central South University
name: Central South University
name: China-Japan Friendship Hospital
First posted: 2024-04-12
Enrollment: 6000
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

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

Primary outcomes:
measure: Postoperative mortality rate
timeFrame: up to 12 month
Secondary outcomes:
measure: The incidence of postoperative delirium
timeFrame: During hospitalization (up to 1 month)
measure: The incidence of postoperative anxiety
timeFrame: Anxiety within 7 days of surgery
measure: The incidence of postoperative depression
timeFrame: Depression within 7 days of surgery
measure: Postoperative sleep disorders
timeFrame: within 6 months after surgery
measure: Surgical related complications
timeFrame: within 12 months after surgery
measure: Postoperative quality of life evaluation
timeFrame: within 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: WEIDONG MI, PhD
role: STUDY_CHAIR
References: