Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
1 other identifier
interventional
240
1 country
1
Brief Summary
The purpose of this study is to determine whether postoperative analgesia pump continuous infusion of dexmedetomidine are effective in the prevention of Postoperative delirium and Postoperative cognitive dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJuly 20, 2023
July 1, 2023
3.9 years
September 11, 2016
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative delirium
The four clinical criteria for CAM-ICU are as follows: (1) acute onset with fluctuating course of disease; (2) inattention; (3) altered level of consciousness; (4) disorganized thinking. Delirium can be diagnosed by the appearance of both features 1 and 2, with at least one of features 3 or 4.
7 days after surgery
Secondary Outcomes (2)
NRS for pain
3 days after surgery
Adverse events
3 days after surgery
Study Arms (2)
Dexmedetomidine+routine PCIA
ACTIVE COMPARATORPCIA pump was provided after surgery, which consisted of 3 ug/kg sufentanil and 3 ug/kg dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h.
Routine PCIA
SHAM COMPARATOR3 ug/kg sufentanil without dexmedetomidine, total amount 150ml, 2 mL bolus dose with a lock-out of 10 minutes and background infu-sion rate 2 mL/h.
Interventions
Dexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
Saline is used to dilute other drugs
Eligibility Criteria
You may qualify if:
- Patients' age ≥60 years
- Underwent elective non-cardiac surgery under general anesthesia
You may not qualify if:
- Patients with severe bradycardia (heart rate\<55bpm)
- Severe arrhythmia or cardiac dysfunction (ejection fraction\<35%)
- Preoperative clear systems and spiritual history of neurological disease or long-term use of sedatives or antidepressants
- History of alcohol abuse or a history of drug dependence
- Have brain surgery or trauma
- Severe vision or hearing impairment
- Cannot with the completion of tests of cognitive function
- Refused to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 11, 2016
First Posted
October 4, 2016
Study Start
November 1, 2016
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
July 20, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share