Postoperative DeliriumNCT06164314
Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors
A study testing Dexmedetomidine in people with Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with temporal glioma scheduled for a elective craniotomy
- Age ≥18 years
- Obtain written informed consent.
Who cannot join
- Patients with severe preoperative cognitive impairment
- History of traumatic brain injury or previous neurosurgery
- History of psychotropic medications
- Allergy to dexmedetomidine
- Pregnant or lactating women
- History of obstructive sleep apnoea syndrome
Show all 9Show fewer
- Severe bradycardia(heart rate <40 beats/min), sick sinus syndrome or second-to-third degree atrioventricular block
- Severe hepatic dysfunction
- Severe renal dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing
Yuming Peng, 0086+18601076588, florapym766@163.com
About this study
Official title: Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial
Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium
Read the detailed description
The investigators will be required to attend the professional training before recruitment and strictly adhere to the study protocol. All the raw data will be recorded in the case report forms. Data will be entered doubly performed by two investigators and monitored securely in an electronic database with password protection at the medical center. The data base will be locked after all data have been cleaned. All the original fles will be maintained in storage for 5 years after completion of the study.
- Conditions
- Postoperative Delirium
- Being tested
- Dexmedetomidine
- 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
In Dex group, dexmedetomidine will continue to be used during and after surgery, with a infusion of 0.4ug/kg/ h from anesthesia induction to dural closure, and then 0.08ug/kg/ h to 48 hours postoperatively.In placebo group, equivalent normal saline will be injected during operation, and the intravenous analgesia pump will not contain dexmedetomidine after operation
| Study group | Role | What they receive |
|---|---|---|
| Dex group | Experimental | Subjects assigned to Dex group will receive a continuous dexmedetomidine infusion (0.4 ug/kg/h) after anesthesia induction until dural closure, and then received an intravenous analgesia pump with dexmedetomidine(0.08ug/kg/h), sufentanil and antiemetic until 48 hours postoperatively Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | Subjects in the Placebo group were given comparable volumes of normal saline during the surgery, and intravenous analgesia pump also contains sufentanil and antiemetic, but no dexmedetomidine used until 48 hours postoperatively. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of delirium postoperatively
Using the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessment,combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments will be only conducted in patients with RASS sedation score exceeding -4.The CAM-ICU and the 3D-CAM describes four main characteristics of delirium: acute altered mental state ,fluctuating level of consciousness, inattention, and confusion of thought. If both the first and second features are present, and both the third or fourth features are present, the patient is diagnosed with postoperative delirium.
Measured: the postoperative 5 days
Secondary outcomes (4)
the severity of postoperative delirium
Using the Delirium Rating Scale-Revised -98 (DRS-R-98) to assess.There are 3 diagnostic items (0~2 or 0~3 points each) and 13 severity assessment items (0~3 points each), for a total of 46 points. The higher the score, the more severe the delirium.
Measured: the postoperative 5 days
the intensity of pain
Using numerical rating scale (NRS) for pain to assess, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.
Measured: the postoperative 5 days
the quality of sleep
The Richards-Campbell Sleep Questionnaire (RCSQ) will be used to assess subjective sleep quality. The scale is composed of 5 items, including sleep depth, sleep latency, wake times, return to sleep and overall sleep quality, all of which are scored by 0 ~ 100mm visual simulation (1 mm=1 point). The total score of the scale is the average score of the 5 items, and the higher the score, the better the sleep quality.
Measured: the postoperative 5 days
safety outcomes
Safety outcomes includes the incidence of hypotension (systolic blood pressure below 95mmHg or below 30% of baseline), hypertension (systolic blood pressure above 180mmHg or 30% above baseline), bradycardia (heart rate less than 40 beats per minute), tachycardia (heart rate more than 100 beats per minute), delayed extubation (more than from the end of surgery to 2 hours after surgery, for the ICU patients (more than 4 hours),hypoxemia (SpO2<90%)
Measured: from the start of medicine infusion to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start25 Jan 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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 Postoperative DeliriumStudies 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
- 366 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, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164314
- Sponsor's protocol ID
- 2023064
- Status last verified
- Feb 2025
- First submitted
- 12 Nov 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zeng M, Zheng M, Wang J, Li S, Ji N, Peng Y. Effect of perioperative dexmedetomidine on postoperative delirium in patients with brain tumours: a protocol of a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e084380. doi: 10.1136/bmjopen-2024-084380.
PubMed 39515867
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Dexmedetomidine on Postoperative Delirium in Patients With Brain Tumors: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06164314
- Acronym / sponsor ID
- 2023064
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Dec 2023 (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.
Neurosurgery is a risk factor for delirium. Dexmedetomidine might reduce delirium by reducing neuroinflammation, improving postoperative analgesia and sleep quality. The the primary hypothesis is that perioperative administration of dexmedetomidine can reduce the incidence of postoperative delirium
Detailed description
The investigators will be required to attend the professional training before recruitment and strictly adhere to the study protocol. All the raw data will be recorded in the case report forms. Data will be entered doubly performed by two investigators and monitored securely in an electronic database with password protection at the medical center. The data base will be locked after all data have been cleaned. All the original fles will be maintained in storage for 5 years after completion of the study.
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 | Experimental | Drug: DexmedetomidineSubjects assigned to Dex group will receive a continuous dexmedetomidine infusion (0.4 ug/kg/h) after anesthesia induction until dural closure, and then received an intravenous analgesia pump with dexmedetomidine(0.08ug/kg/h), sufentanil and antiemetic until 48 hours postoperatively |
| Placebo group | Placebo comparator | Drug: DexmedetomidineSubjects in the Placebo group were given comparable volumes of normal saline during the surgery, and intravenous analgesia pump also contains sufentanil and antiemetic, but no dexmedetomidine used until 48 hours postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with temporal glioma scheduled for a elective craniotomy
- Age ≥18 years
- Obtain written informed consent.
Key exclusion criteria (9 listed)
- Patients with severe preoperative cognitive impairment
- History of traumatic brain injury or previous neurosurgery
- History of psychotropic medications
- Allergy to dexmedetomidine
- Pregnant or lactating women
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 |
|---|---|---|
| DexmedetomidineIn Dex group, dexmedetomidine will continue to be used during and after surgery, with a infusion of 0.4ug/kg/ h from anesthesia induction to dural closure, and then 0.08ug/kg/ h to 48 hours postoperatively.In placebo group, equivalent normal saline will be injected during operation, and the intravenous analgesia pump will not contain dexmedetomidine after operation | Drug | Dex group, Placebo group |
Primary outcome
the incidence of delirium postoperatively
Time frame: the postoperative 5 days
Using the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) for critical care patients, or the 3-min Diagnostic interview for Confusion Assessment Method (3D-CAM) for ward assessment,combined with the Richmond Agitation Sedation Scale (RASS). Delirium assessments will be only conducted in patients with RASS sedation score exceeding -4.The CAM-ICU and the 3D-CAM describes four main characteristics of delirium: acute altered mental state ,fluctuating level of consciousness, inattention, and confusion of thought. If both the first and second features are present, and both the third or fourth features are present, the patient is diagnosed with postoperative delirium.
4 secondary outcomes
the severity of postoperative delirium
Time frame: the postoperative 5 days
the intensity of pain
Time frame: the postoperative 5 days
the quality of sleep
Time frame: the postoperative 5 days
safety outcomes
Time frame: from the start of medicine infusion to 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 39515867Zeng M, Zheng M, Wang J, Li S, Ji N, Peng Y. Effect of perioperative dexmedetomidine on postoperative delirium in patients with brain tumours: a protocol of a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e084380. doi: 10.1136/bmjopen-2024-084380.
- 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.
Yuming Peng 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 in people with 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 3 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuming Peng (0086+18601076588, 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 delirium postoperatively (time frame: the 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 NCT06164314, 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 17 Feb 2025.