Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients
- Registration Number
- NCT06362408
- Lead Sponsor
- Chinese PLA General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description the DEX group Dexmedetomidine used DEX (safe use range: 0.2\~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery
- Primary Outcome Measures
Name Time Method Postoperative mortality rate up to 12 month the 12-month all-cause mortality
- Secondary Outcome Measures
Name Time Method The incidence of postoperative delirium During hospitalization (up to 1 month) the incidence of postoperative delirium (3D-CAM scale).Delirium was defined as acute, transient, fluctuating, and usually reversible disturbances in attention, cognition, or attention level. It was assessed every 12 hours by trained nurses using the confusion assessment method (CAM).
The incidence of postoperative anxiety Anxiety within 7 days of surgery The GAD-7 is a seven-item questionnaire for screening on the presence of generalized anxiety disorder and assessing its severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-one. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe anxiety. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety.
Postoperative sleep disorders within 6 months after surgery The Hamilton Depression Scale (HAMD) sleep-related data and the Pittsburgh sleep quality index (PSQI) were used to evaluate the postoperative sleep abnormalities of the patients.
The incidence of postoperative depression Depression within 7 days of surgery Primary outcomes were depression Patient Health Questionnaire 9 (PHQ-9).The PHQ-9 is a nine-item questionnaire for screening on the presence of depressive symptoms and monitoring depression severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-seven. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe level of depression. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of depression. The higher the score, the worse the situation. The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms.
Surgical related complications within 12 months after surgery Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.
Postoperative quality of life evaluation within 12 months after surgery Five-dimensional health scale EQ-5D, the five-dimensional health scale consists of 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression. Each dimension contains three levels: no difficulty, some difficulty, and extreme difficulty. Through the conversion of effect size, the respondents can make choices at the five dimensions and three levels in the questionnaire, and calculate the score of the five-dimensional health scale index.
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China