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

Cohort Studies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06362408
• Other study ID #: PLAGH-DEX-PSM/IPTW-001
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: June 1, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Cohort Studies
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (7)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Tiantan Hospital, First Affiliated Hospital of Guangxi Medical University, Fudan University, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative mortality rate	the 12-month all-cause mortality	up to 12 month
Secondary	The incidence of postoperative delirium	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).	During hospitalization (up to 1 month)
Secondary	The incidence of postoperative anxiety	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.	Anxiety within 7 days of surgery
Secondary	The incidence of postoperative depression	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.	Depression within 7 days of surgery
Secondary	Postoperative sleep disorders	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.	within 6 months after surgery
Secondary	Surgical related complications	Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.	within 12 months after surgery
Secondary	Postoperative quality of life evaluation	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.	within 12 months after surgery