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DexmedetomidineNCT04674241

Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. Read more about this study

Who is it for?
Ages 18 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
260 participants
Where
2 sitesChina
Study dates
18 Jan 2021to 28 Jan 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing selective frontotemporal tumor resection.
  • Age ≥18 years.
  • Obtain written informed consent.

Who cannot join

  • Refusal to provide written informed consent.
  • Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
  • Allergic to the study drug.
  • History of psychotropic drugs within past 30 days.
  • Pregnant or lactating women.
  • 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 hepatic or renal dysfunction.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing TianTan Hospital,Capital Medical University

    Beijing, Beijing,China, 100070

  • PLA General Hospital

    Beijing, 100853

Other trials in China

About this study

Official title: Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study

Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.

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

    Ten minutes after anesthesia induction and endotracheal intubation, patients assigned to dexmedetomidine group were given a loading dose of dexmedetomidine 0.6 μg/kg over 10 minutes, followed by continuous infusion at a rate of 0.4 μg/kg/h until the start of dural closure.

  • 0.9% salineDrug

    0.9% saline is administered with the same volume at the same speed as the other group.

Study groups in NCT04674241
Study groupRoleWhat they receive
DEX groupActive comparatorThe DEX group will receives dexmedetomidine intraoperative.
Receives: Drug: Dexmedetomidine
Placebo groupPlacebo comparatorThe placebo group will receives 0.9% saline intraoperative.
Receives: Drug: 0.9% saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (4)

  1. Pain score

    Numerical Rating Scales, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.

    Measured: within 5 days after surgery

  2. Sleep quality

    Quality of sleep was assessed by the Richards Campbell sleep questionnaire (RCSQ) and with a 0-100-mm visual analog scale, with higher scores indicating better sleep quality.

    Measured: within 3 days after surgery

  3. Quality of recovery from surgery

    Postoperative quality of recovery was assessed through the Quality of Recovery 15 item

    Measured: 1 day after surgery

  4. Intraoperative cardiovascular event.

    Including: hypotension was defined as systolic blood pressure <95 mm Hg or less than 30% below baseline; hypertension was defined as systolic blood pressure > 180 mm Hg or more than 30% above baseline; bradycardia was defined by heart rate <40 bpm, and tachycardia was defined by heart rate >100 bpm.

    Measured: From the study drug infusion to the end of surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start18 Jan 2021
  3. Primary completion31 Dec 2021
  4. Study completion28 Jan 2022

Resources

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
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04674241
Sponsor's protocol ID
ChiECRCT20200436
Status last verified
Mar 2022
First submitted
13 Dec 2020
Last updated
4 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu Y, Ren Y, Li S, Zeng M, Wang J, Li M, Peng Y. Association between intraoperative hypotension during brain tumor resection and postoperative delirium: A secondary analysis of a randomized controlled trial. PLoS One. 2025 Oct 29;20(10):e0334094. doi: 10.1371/journal.pone.0334094. eCollection 2025.

    PubMed 41160633

  • Zeng M, Xu X, Li R, Zhang X, Ma T, Cui Q, Wang J, Li S, Peng Y. Dexmedetomidine Prevents Chronic Incisional Pain After Brain Tumor Resection: A Secondary Analysis of the Randomized Control Trial. Anesth Analg. 2024 Apr 1;138(4):839-847. doi: 10.1213/ANE.0000000000006563. Epub 2023 Jun 12.

    PubMed 37307232

  • Li S, Li R, Li M, Cui Q, Zhang X, Ma T, Wang D, Zeng M, Li H, Bao Z, Peng Y, Sessler DI. Dexmedetomidine administration during brain tumour resection for prevention of postoperative delirium: a randomised trial. Br J Anaesth. 2023 Feb;130(2):e307-e316. doi: 10.1016/j.bja.2022.10.041. Epub 2022 Dec 13.

    PubMed 36517290

  • Wang D, Li R, Li S, Wang J, Zeng M, Dong J, Liu X, Lin N, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial. BMJ Open. 2021 Nov 10;11(11):e051584. doi: 10.1136/bmjopen-2021-051584.

    PubMed 34758995

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 8 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 4 Apr 2022. 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 NCT04674241, which also lists 4 linked publications.

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 4 Apr 2022.

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