DexmedetomidineNCT05168280
Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients
A study testing Dexmedetomidine and 0.9% saline in people with Dexmedetomidine and Postoperative Delirium, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dexmedetomidine, Postoperative Delirium
- What is being tested?
- Dexmedetomidine and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jul 2022to 30 Jun 2026
- 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
- Patients undergoing selective craniotomy.
- Age ≥65 years.
- Obtain written informed consent.
Who cannot join
- Operation time less than 2 hours.
- Refusal to provide written informed consent.
- Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
- Allergic to the study drug.
- Body mass index ≤18 or ≥ 30 kg/m2.
- History of psychotropic drugs, anticholinergic drugs, antihistamine drug and dopaminergic drugs.
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- History of traumatic brain injury or neurosurgery.
- Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
- Severe liver dysfunction (Child-Pugh grade C) or renal failure (requiring kidney replacement therapy).
- The functional neurosurgery.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.
- Conditions
- Dexmedetomidine, Postoperative Delirium
- 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 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively.
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 | The DEX group patients will be received dexmedetomidine intraoperatively. Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | The placebo group patients will be received 0.9% saline intraoperatively. 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.
Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present.
In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.
Measured: postoperative 5 day
Secondary outcomes (11)
Pain severity score
The degree of surgical incision pain will be assessed at rest and on movement by Numerical Rating Scale (NRS). NRS ranges from 0 to 10, with the highest score indicating the worst pain.
Measured: postoperative 5 day
The quality of recovery
The quality of recovery will be assessed with 15-item quality of recovery questionnaire (QoR-15). The QoR-15 measures cognitive function, physical activity, language and mood on a 150-point scale, with higher scores indicating better quality of recovery.
Measured: postoperative 1 day
The quality of sleep
The quality of sleep will be assessed by the Richards Campbell sleep questionnaire (RCSQ).RCSQ is mainly used to evaluate the sleep quality of the previous night. The scale comprises five items: sleep depth, sleep latency, wake up times, relapse to sleep and overall sleep quality.The total score of the scale is the average of 5 items, and the lower the score, the better the sleep quality.
Measured: postoperative 3 day
Cognitive function
Cognitive function will be assessed 1 day before surgery and 5 days after surgery using MMSE scale and Montreal Cognitive Assessment (MoCA) scale. MMSE includes seven items: time orientation, place orientation, immediate memory, attention and calculation, delayed memory, language and visual space.A total of 30 questions will be asked, 1 point for each correct answer, 0 point for a wrong answer or unknown answer and the total score range from 0 to 30. MoCA scale was widely identified that MoCA was superior to MMSE in the detection of mild cognitive impairment. Furthermore, the MoCA showed differences in cognitive profile even in those performing in the normal range on the MMSE and would appear to be a useful brief tool to assess cognition in those with mild cognitive impairment.
Measured: 1 day before surgery and 5 days after surgery
Psychological health state
Psychological health state will be assessed by Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9).There are 7 and 9 items to screen anxiety and depression, respectively. The point of each item is 3. The total points >4 will be regarded as anxiety and depression.
Measured: 1 day before surgery and postoperative 5 day
The intraoperative data
Intraoperative data include total dose of anesthetics, bispectral index scale value, and cardiovascular adverse events will be recorded and classified as hypotension (systolic blood pressure<95mmHg, or lower than 30% baseline), hypertension (systolic blood pressure ≥180 mmHg, or higher than 30% baseline), bradycardia (heart rate <40 beats /min), tachycardia (heart rate ≥ 100 beats /min) or hypoxemia (pulse oxygen saturation<90%).
Measured: The surgery day
Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.
Non-delirium complications include cardiac arrest, infection of the incision, sepsis, intracranial hematoma, severe intracranial edema (base on brain images), stroke, myocardial infarction, pulmonary infection and embolism.
Measured: postoperative 5 day
30-day all-cause mortality
Postoperative 30-day all-cause mortality.
Measured: postoperative 30 day
The physiological status
The physiological status of the patients will be assessed by Short-Form Mini-nutrition assessment (MNA-SF) and FRAIL scale.
Measured: 1 day before surgery
Electroencephalogram changes
Electroencephalogram will be used to record the brain activity.
Measured: The surgery day
Regional cerebral oxygen saturation changes
Regional cerebral oxygen saturation will be monitored with near-infrared spectroscopy.
Measured: The surgery day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start18 Jul 2022
- Primary completion30 May 2026
- Study completion30 Jun 2026
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
- 420 participants (actual)
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
- NCT05168280
- Sponsor's protocol ID
- 2021-12-05
- Status last verified
- Aug 2026
- First submitted
- 13 Dec 2021
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.
Publications
Cui Q, Ma T, Liu M, Shen Z, Li S, Zeng M, Liu X, Zhang L, Peng Y. Intraoperative infusion of dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing craniotomy: a protocol of randomised clinical trial. BMJ Open. 2023 Jan 23;13(1):e063976. doi: 10.1136/bmjopen-2022-063976.
PubMed 36690404
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Craniotomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05168280
- Acronym / sponsor ID
- 2021-12-05
- Conditions
- Dexmedetomidine, Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Dec 2021 (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 surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.
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: DexmedetomidineThe DEX group patients will be received dexmedetomidine intraoperatively. |
| Placebo group | Placebo comparator | Drug: 0.9% salineThe placebo group patients will be received 0.9% saline intraoperatively. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients undergoing selective craniotomy.
- Age ≥65 years.
- Obtain written informed consent.
Key exclusion criteria (10 listed)
- Operation time less than 2 hours.
- Refusal to provide written informed consent.
- Cognitive impairment before surgery(mini-mental state examination, MMSE ≤ 26 or Montreal Cognitive Assessment, MoCA≤22).
- Allergic to the study drug.
- Body mass index ≤18 or ≥ 30 kg/m2.
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 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively. | 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 day
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. Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present. In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.
11 secondary outcomes
Pain severity score
Time frame: postoperative 5 day
The quality of recovery
Time frame: postoperative 1 day
The quality of sleep
Time frame: postoperative 3 day
Cognitive function
Time frame: 1 day before surgery and 5 days after surgery
Psychological health state
Time frame: 1 day before surgery and postoperative 5 day
The intraoperative data
Time frame: The surgery day
Length of stay in ICU and hospital, hospitalization costs, and non-delirium complications.
Time frame: postoperative 5 day
30-day all-cause mortality
Time frame: postoperative 30 day
The physiological status
Time frame: 1 day before surgery
Electroencephalogram changes
Time frame: The surgery day
Regional cerebral oxygen saturation changes
Time frame: The surgery day
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 28 Aug 2026.
- Derived from this study: PubMed 36690404Cui Q, Ma T, Liu M, Shen Z, Li S, Zeng M, Liu X, Zhang L, Peng Y. Intraoperative infusion of dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing craniotomy: a protocol of randomised clinical trial. BMJ Open. 2023 Jan 23;13(1):e063976. doi: 10.1136/bmjopen-2022-063976.
- Individual participant dataSharing planned: Yes. Study protocol and de-identified individual participant data could be shared after 1 year after publication with the permission of principle investigator for reasonable usage.
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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
2 sites 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 2 sites 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 10 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
The incidence of postoperative delirium (time frame: postoperative 5 day). 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 NCT05168280, 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 28 Aug 2026.