Cohort StudiesNCT06362408

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

An observational study of Cohort Studies, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 65 to 110 years
Conditions the study is for: Cohort Studies
What is being tested?: Dexmedetomidine
How many people: 6,000 participants
Where: 1 siteChina
Study dates: 1 Jun 2022to 1 Jun 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 110 years
All sexes
No healthy volunteers
Older adult

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.

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

China1 site

Chinese PLA General Hospital
Beijing, Beijing Municipality

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Cohort Studies
Being tested: Dexmedetomidine
Keywords: Dexmedetomidine, Postoperative mental disorders, Long-term survival, Elderly patients, depression, anxiety, delirium
Medical subject headings: Depression, Anxiety Disorders, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
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.

Study groups in NCT06362408
Study group	Role	What they receive
the DEX group		used DEX (safe use range: 0.2~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery Receives: Drug: Dexmedetomidine
the Non-DEX group		did not use DEX throughout the entire anesthesia process

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative mortality rate
the 12-month all-cause mortality
Measured: up to 12 month

Secondary outcomes (6)

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).
Measured: During hospitalization (up to 1 month)
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.
Measured: Anxiety within 7 days of surgery
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.
Measured: Depression within 7 days of surgery
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.
Measured: within 6 months after surgery
Surgical related complications
Surgery-related complications include cardiovascular, respiratory, pulmonary, digestive, urinary, neurological, infection, pain, and bleeding from the surgery.
Measured: within 12 months after surgery
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.
Measured: within 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20221 Jun 2023

First posted12 Apr 2024
Study start1 Jun 2022
Primary completion25 May 2023
Study completion1 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cohort StudiesStudies of the same condition, open and under way.
More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 6,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06362408
Sponsor's protocol ID: PLAGH-DEX-PSM/IPTW-001
Status last verified: Oct 2024
First submitted: 9 Apr 2024
Last updated: 4 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hao X, Zhang Z, Yang L, Guo Y, Cao F, Cao J, Liu Y, Lou J, Xu Z, Cui Y, Bai Y, Gu X, Wang D, Cui Q, Zhou Z, Shen H, Sun J, Mi W, Tong L. Association of Dexmedetomidine With Postoperative Depressive Symptoms in Older Surgical Patients: A Prospective Multicenter Study. CNS Neurosci Ther. 2025 May;31(5):e70407. doi: 10.1111/cns.70407.
PubMed 40387522

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Intraoperative Use of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients Undergoing Non-cardiac Surgery
ClinicalTrials.gov ID: NCT06362408
Acronym / sponsor ID: PLAGH-DEX-PSM/IPTW-001
Conditions: Cohort Studies
Keywords: Dexmedetomidine, Postoperative mental disorders, Long-term survival, Elderly patients, depression, anxiety, delirium
Study type: Observational
Recruitment status: Completed
Enrolment: 6,000 participants (actual)
Lead sponsor: Chinese PLA General HospitalUniversity, hospital or other
Collaborators: Beijing Tiantan Hospital, First Affiliated Hospital of Guangxi Medical University, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Peking University People's Hospital, The First Xiangya Hospital of Central South University, Second Xiangya Hospital of Central South University, China-Japan Friendship Hospital
Study start: 1 Jun 2022 (actual)
Primary completion: 25 May 2023 (actual)
Study completion: 1 Jun 2023 (actual)
First posted: 12 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
the DEX group	–	Drug: Dexmedetomidineused DEX (safe use range: 0.2~1.0 μg/(kg·h)) for anesthesia induction or maintenance during surgery
the Non-DEX group	–	–did not use DEX throughout the entire anesthesia process

Who may qualify

Ages: 65 to 110 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineOlder 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.	Drug	the DEX group

Primary outcome

Postoperative mortality rate
Time frame: up to 12 month
the 12-month all-cause mortality

6 secondary outcomes

The incidence of postoperative delirium
Time frame: During hospitalization (up to 1 month)
The incidence of postoperative anxiety
Time frame: Anxiety within 7 days of surgery
The incidence of postoperative depression
Time frame: Depression within 7 days of surgery
Postoperative sleep disorders
Time frame: within 6 months after surgery
Surgical related complications
Time frame: within 12 months after surgery
Postoperative quality of life evaluation
Time frame: within 12 months after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Derived from this study: PubMed 40387522Hao X, Zhang Z, Yang L, Guo Y, Cao F, Cao J, Liu Y, Lou J, Xu Z, Cui Y, Bai Y, Gu X, Wang D, Cui Q, Zhou Z, Shen H, Sun J, Mi W, Tong L. Association of Dexmedetomidine With Postoperative Depressive Symptoms in Older Surgical Patients: A Prospective Multicenter Study. CNS Neurosci Ther. 2025 May;31(5):e70407. doi: 10.1111/cns.70407.
Individual participant dataSharing planned: No

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RecruitingObservational study
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Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

WEIDONG MI, PhD study chair

Chinese PLA General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cohort Studies, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative mortality rate (time frame: up to 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06362408, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.