Postoperative Cognitive DysfunctionPhase 4NCT02923128
Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
A Phase 4 study testing Dexmedetomidine, Sufentanyl and Saline in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Dexmedetomidine, Sufentanyl and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Oct 2020
- Phase
- Phase 4
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age ≥60 years
- Underwent elective non-cardiac surgery under general anesthesia
Who cannot join
- Patients with severe bradycardia (heart rate<55bpm)
- Severe arrhythmia or cardiac dysfunction (ejection fraction<35%)
- Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25
- 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
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- Severe vision or hearing impairment
- Cannot with the completion of tests of cognitive function
- Refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
- collection of cases: This trail is approved by Hospital Ethics Committee, and patients who participated in the study signed the informed consent. The subject will select 300 elder patients (age ≥60 years) routine tumor surgery, American Society of Anesthesiologists classificationⅠ-Ⅲ. Preoperative liver and kidney function, blood electrolytes were in the normal range.
- Case group: Selected cases divided into the right dexmedetomidine group and control group by computer randomly, 150 patients in each group. Dexmedetomidine group (A group) analgesia pump formula is: 3 ug/kg sufentanil and 3 ug/kg dexmedetomi-dine, with 0.9% saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: 3 ug/kg sufentanil, with 0.9% saline diluted to 150ml. Two group with the same anesthesia program.
- Our primary outcome was the 7-day incidence of postoperative delirium assessed by CAM-ICU twice daily (8 a.m. and 8 p.m.) and supplemented with a review of medical and nursing records. The assessment was carried out by investigators who had been trained prior to the trial and were unaware of the group assignment.All investigators and patients were unknown of experiments and results. 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. RASS was used to measure sedation or agita-tion prior to testing delirium. If the patient was deeply sedated or unable to fall asleep (RASS - 4 or - 5), delirium assessment was halted; if RASS score was of - 3 or above, delirium was evaluated by CAM-ICU.
- Being tested
- Dexmedetomidine, Sufentanyl, Saline
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride Injection
Dexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
SufentanylDrug
Also called Sufentanil Citrate Injection
Sufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
SalineDrug
Also called normal saline,physiological saline,NS
Saline is used to dilute other drugs
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine+routine PCIA | Active comparator | PCIA 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. Receives: Drug: Dexmedetomidine; Drug: Sufentanyl; Drug: Saline |
| Routine PCIA | Sham comparator | 3 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. Receives: Drug: Sufentanyl; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after surgery
Secondary outcomes (2)
NRS for pain
Pain was assessed by NRS (Numeric Rating Scale) : assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Measured: 3 days after surgery
Adverse events
including hypotension, hypertension, bradycardia, tachycardia, hypoxemia, and in-terventions (adjustment or stop study drug infusion or intravenous administration).
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Kangjie, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923128
- Sponsor's protocol ID
- 2015-01-13
- Status last verified
- Jul 2023
- First submitted
- 11 Sep 2016
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Dexmedetomidine Can Improve the Prognosis of Elderly Patients With Postoperative Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT02923128
- Acronym / sponsor ID
- 2015-01-13
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
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.
Detailed description
- collection of cases: This trail is approved by Hospital Ethics Committee, and patients who participated in the study signed the informed consent. The subject will select 300 elder patients (age ≥60 years) routine tumor surgery, American Society of Anesthesiologists classificationⅠ-Ⅲ. Preoperative liver and kidney function, blood electrolytes were in the normal range.
- Case group: Selected cases divided into the right dexmedetomidine group and control group by computer randomly, 150 patients in each group. Dexmedetomidine group (A group) analgesia pump formula is: 3 ug/kg sufentanil and 3 ug/kg dexmedetomi-dine, with 0.9% saline diluted to 150ml. Control group (group C) postoperative analgesia formula is: 3 ug/kg sufentanil, with 0.9% saline diluted to 150ml. Two group with the same anesthesia program.
- Our primary outcome was the 7-day incidence of postoperative delirium assessed by CAM-ICU twice daily (8 a.m. and 8 p.m.) and supplemented with a review of medical and nursing records. The assessment was carried out by investigators who had been trained prior to the trial and were unaware of the group assignment.All investigators and patients were unknown of experiments and results. 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. RASS was used to measure sedation or agita-tion prior to testing delirium. If the patient was deeply sedated or unable to fall asleep (RASS - 4 or - 5), delirium assessment was halted; if RASS score was of - 3 or above, delirium was evaluated by CAM-ICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine+routine PCIA | Active comparator | Drug: Dexmedetomidine, Drug: Sufentanyl, Drug: SalinePCIA 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 comparator | Drug: Sufentanyl, Drug: Saline3 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. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients' age ≥60 years
- Underwent elective non-cardiac surgery under general anesthesia
Key exclusion criteria (9 listed)
- Patients with severe bradycardia (heart rate<55bpm)
- Severe arrhythmia or cardiac dysfunction (ejection fraction<35%)
- Mini-Mental Scale Test (MMSE) Exclusion criteria: illiteracy <18, primary school <21, junior school and above <25
- 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
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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine Hydrochloride InjectionDexmedetomidine 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed. | Drug | Dexmedetomidine+routine PCIA |
| SufentanylAlso: Sufentanil Citrate InjectionSufentanyl 3 ug/kg is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed. | Drug | Dexmedetomidine+routine PCIA, Routine PCIA |
| SalineAlso: normal saline,physiological saline,NSSaline is used to dilute other drugs | Drug | Dexmedetomidine+routine PCIA, Routine PCIA |
Primary outcome
Incidence of postoperative delirium
Time frame: 7 days after surgery
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.
2 secondary outcomes
NRS for pain
Time frame: 3 days after surgery
Adverse events
Time frame: 3 days 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 20 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Sufentanyl and Saline in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Zhejiang Cancer 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 2 inclusion and 9 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 20 Jul 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of postoperative delirium (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2023.