Delirium in Old AgeNCT06382961
Postoperative Dexmedetomidine in Prevention of Postoperative Delirium
A study testing Dexmedetomidine injection and Sufentanil injection in people with Delirium in Old Age and Anesthesia; Adverse Effect, run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are : 1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery? 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age, Anesthesia; Adverse Effect
- What is being tested?
- Dexmedetomidine injection and Sufentanil injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2023to 28 Apr 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- elective surgery for lobectomy or segmentectomy
Who cannot join
- local allergy to anesthetics;
- patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;
- history of alcoholism, drug abuse or drug dependence;
- have a history of brain surgery or injury;
- epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;
- sick sinus syndrome, second-degree or greater atrioventricular block or other contraindications for use of α2 adrenergic agonist;
- liver and kidney insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lung Surgery: A Randomized Controlled Trial
The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :
- Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
- Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.
Participants will undergo routine postoperative care:
- Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
- Postoperative visit twice a day for at least seven days
- Conditions
- Delirium in Old Age, Anesthesia; Adverse Effect
- Being tested
- Dexmedetomidine injection, Sufentanil injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Combining with 3 μg.kg-1 sufentanil, 3 μg.kg-1 dexmedetomidine is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.
Sufentanil injectionDrug
3 μg.kg-1 sufentanil is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour.
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Not described Receives: Drug: Dexmedetomidine injection |
| Control | Active comparator | Not described Receives: Drug: Sufentanil injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium
Measured: Delirium is assessed at 8 am and 8 pm for 3 days after surgery
Secondary outcomes (3)
Incidence of postoperative nausea and vomiting
Measured: Assessed twice a day for 7days after surgery
incidence of postoperative complications
Other postoperative complications including including hypotension, hypertension, bradycardia, tachycardia, and hypoxemia
Measured: Assessed daily for 3 days after surgery
Pain intensities
patient pain assessed using numeric rating scale, ranged from 0 to 11, higher score indicate higher pain intensity
Measured: Assessed daily at 8 am for 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 posted25 Apr 2024
- Study start11 Nov 2023
- Primary completion6 Mar 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen People's Hospital, Dongyuan People's Hospital, Kunming Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Rui Zhao, Study director, Department of Anesthesiology, Kunming Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382961
- Sponsor's protocol ID
- SZUS_231101
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lung Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06382961
- Acronym / sponsor ID
- SZUS_231101
- Conditions
- Delirium in Old Age, Anesthesia; Adverse Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen People's Hospital, Dongyuan People's Hospital, Kunming Children's Hospital
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 25 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.
The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :
- Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
- Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.
Participants will undergo routine postoperative care:
- Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
- Postoperative visit twice a day for at least seven days
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Drug: Dexmedetomidine injection |
| Control | Active comparator | Drug: Sufentanil injection |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- elective surgery for lobectomy or segmentectomy
Key exclusion criteria (7 listed)
- local allergy to anesthetics;
- patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;
- history of alcoholism, drug abuse or drug dependence;
- have a history of brain surgery or injury;
- epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;
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 |
|---|---|---|
| Dexmedetomidine injectionCombining with 3 μg.kg-1 sufentanil, 3 μg.kg-1 dexmedetomidine is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour. | Drug | Experiment |
| Sufentanil injection3 μg.kg-1 sufentanil is injected through intravenous patient controlled anesthesia pump in a 2 ml bolus with 20 minutes lock-out, and a background infusion rate of 2 ml per hour. | Drug | Control |
Primary outcome
Incidence of postoperative delirium
Time frame: Delirium is assessed at 8 am and 8 pm for 3 days after surgery
3 secondary outcomes
Incidence of postoperative nausea and vomiting
Time frame: Assessed twice a day for 7days after surgery
incidence of postoperative complications
Time frame: Assessed daily for 3 days after surgery
Pain intensities
Time frame: Assessed daily at 8 am for 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 24 May 2024.
- 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.
Rui Zhao study director
Department of Anesthesiology, Kunming Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine injection and Sufentanil injection in people with Delirium in Old Age and Anesthesia; Adverse Effect, run by Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. 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 1 inclusion and 7 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 24 May 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?
Incidence of postoperative delirium (time frame: Delirium is assessed at 8 am and 8 pm for 3 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 24 May 2024.