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

C

Chinese PLA General Hospital (301 Hospital)

Status

Completed

Conditions

Cohort Studies

Treatments

Drug: Dexmedetomidine

Study type

Observational

Funder types

Other

Identifiers

NCT06362408
PLAGH-DEX-PSM/IPTW-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

6,000 patients

Sex

All

Ages

65 to 110 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

6,000 participants in 2 patient groups

the DEX group
Description:
used DEX (safe use range: 0.2~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery
Treatment:
Drug: Dexmedetomidine
the Non-DEX group
Description:
did not use DEX throughout the entire anesthesia process

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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