DexmedetomidineNCT05197439
Dexmedetomidine Prevents Postoperative Delirium After Deep Brain Stimulation in Patients With Parkinson's Disease
A study testing Dexmedetomidine and 0.9% saline in people with Dexmedetomidine and Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dexmedetomidine, Postoperative Delirium, Deep Brain Stimulation
- What is being tested?
- Dexmedetomidine and 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 31 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's Disease
- Exist non-motor symptoms
- Undergoing selective DBS.
- Age ≥60 years.
- Obtain written informed consent.
Who cannot join
- preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18)
- history of psychoactive
- allergic or intolerant to dexmedetomidine
- severe bradycardia (heart rate lower than 40 beats/min) or sick sinus syndrome, second-degree or third-degree atrioventricular block
- severe hepatic dysfunction (Child-Pugh class C)
- severe renal dysfunction requiring renal replacement therapy before the surgery
- medical records documented inability to communicate in the preoperative period due to language barrier or other situations.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100160
About this study
Official title: Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial
Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.
- Being tested
- Dexmedetomidine, 0.9% saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
The 4.8ug/kg dexmedetomidine will be diluted into 100ml and pump 2ml/h at the beginning of the second of DBS and last for 48 hours.
0.9% salineDrug
The 0.9% saline is administered with the same volume at the same speed as the other group.
| Study group | Role | What they receive |
|---|---|---|
| DEX group | Active comparator | Dexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump. Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | The placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do. Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium.
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.
Measured: Postoperative 5 days
Secondary outcomes (7)
The severity of postoperative delirium.
The severity of postoperative delirium will be assessed by Delirium Rating Scale-Revised-98.
Measured: Postoperative 5 days
Postoperative pain
Postoperative pain will be assessed with Numerical Rating Scale (NRS). Postoperative analgesia will be recorded.
Measured: within 3 days after surgery.
Quality of recovery.
Quality of recovery will be evaluated with 15-item quality of recovery questionnaire (QoR-15).
Measured: First day after surgery
Quality of sleep
Quality of sleep will be evaluated with the Richards Campbell sleep questionnaire (RCSQ).
Measured: the second and the third day after surgery
Cognitive function
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and the Montreal cognitive assessment-basic (MoCA-B).
Measured: before surgery and 5 days after surgery
Anxiety and depression
Anxiety and depression will be evaluated using Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionaire-9 items (PHQ -9).
Measured: before surgery and 5 days after surgery
Parkinson's disease related status
Parkinson's disease related status will be evaluated by Movement Disorder Society-Sponsored Revision Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Measured: before surgery and 5 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 posted19 Jan 2022
- Study start1 Dec 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, MD,Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197439
- Sponsor's protocol ID
- 20220106
- Status last verified
- Jun 2023
- First submitted
- 5 Jan 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao J, Shen Z, Jin H, Ma T, Wang J, Li S, Zeng M, Liu X, Peng Y. Dexmedetomidine after deep brain stimulation for prevention of delirium in elderly patients with Parkinson's disease: protocol for a single-centre, randomised, double-blind, placebo-controlled trial in China. BMJ Open. 2023 Jul 11;13(7):e070185. doi: 10.1136/bmjopen-2022-070185.
PubMed 37433729
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Postoperative Delirium in Elderly Patients With Parkinson's Disease Undergoing Deep Brain Stimulation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05197439
- Acronym / sponsor ID
- 20220106
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Jan 2022 (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.
Postoperative delirium (POD) is a common complication, and the incidence of POD after deep brain stimulation(DBS) implementation ranges from 10% to 40%. Previous studies suggested that aging and existing non-motor symptom were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing DBS are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine on POD for patients undergoing DBS was seldom reported. The purpose of this study was to investigate the effect of dexmedetomidine on POD in patients with Parkinson' Disease undergoing DBS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX group | Active comparator | Drug: DexmedetomidineDexmedetomidine will be given at the beginning of the second step of DBS and last for 48 hours by electronic pump. |
| Placebo group | Placebo comparator | Drug: 0.9% salineThe placebo group patients will be received 0.9% saline intraoperatively and postoperatively the same duration just like the DEX group would do. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Parkinson's Disease
- Exist non-motor symptoms
- Undergoing selective DBS.
- Age ≥60 years.
- Obtain written informed consent.
Key exclusion criteria (7 listed)
- preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18)
- history of psychoactive
- allergic or intolerant to dexmedetomidine
- severe bradycardia (heart rate lower than 40 beats/min) or sick sinus syndrome, second-degree or third-degree atrioventricular block
- severe hepatic dysfunction (Child-Pugh class C)
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 |
|---|---|---|
| DexmedetomidineThe 4.8ug/kg dexmedetomidine will be diluted into 100ml and pump 2ml/h at the beginning of the second of DBS and last for 48 hours. | Drug | DEX group |
| 0.9% salineThe 0.9% saline is administered with the same volume at the same speed as the other group. | Drug | Placebo group |
Primary outcome
The incidence of postoperative delirium.
Time frame: Postoperative 5 days
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.
7 secondary outcomes
The severity of postoperative delirium.
Time frame: Postoperative 5 days
Postoperative pain
Time frame: within 3 days after surgery.
Quality of recovery.
Time frame: First day after surgery
Quality of sleep
Time frame: the second and the third day after surgery
Cognitive function
Time frame: before surgery and 5 days after surgery
Anxiety and depression
Time frame: before surgery and 5 days after surgery
Parkinson's disease related status
Time frame: before surgery and 5 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 37433729Yao J, Shen Z, Jin H, Ma T, Wang J, Li S, Zeng M, Liu X, Peng Y. Dexmedetomidine after deep brain stimulation for prevention of delirium in elderly patients with Parkinson's disease: protocol for a single-centre, randomised, double-blind, placebo-controlled trial in China. BMJ Open. 2023 Jul 11;13(7):e070185. doi: 10.1136/bmjopen-2022-070185.
- 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.
Yuming Peng, MD,Ph.D principal investigator
Beijing Tiantan 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 and 0.9% saline in people with Dexmedetomidine and Postoperative Delirium, run by Beijing Tiantan 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 5 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: status not confirmed, as of the sponsor's last update on 15 Jun 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuming Peng, MD,Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium. (time frame: Postoperative 5 days). 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 NCT05197439, 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 15 Jun 2023.