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NCT Number: NCT06362408

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

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.

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Key information

Conditions

Cohort Studies Anxiety Disorders Behavior Behavioral Symptoms Confusion Delirium Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative mortality rate

    Time frame: up to 12 month

    the 12-month all-cause mortality

Secondary outcomes

  1. The incidence of postoperative delirium

    Time frame: 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).

  2. The incidence of postoperative anxiety

    Time frame: 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.

  3. The incidence of postoperative depression

    Time frame: 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.

  4. Postoperative sleep disorders

    Time frame: 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.

  5. Surgical related complications

    Time frame: within 12 months after surgery

    Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.

  6. Postoperative quality of life evaluation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

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

Registry information

Official study title

Effect of Intraoperative Use of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients Undergoing Non-cardiac Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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