Brain TumorNCT06863064
Brain Tumor Surgery and Postoperative Delirium
A study testing Dexmedetomidine and Normal Saline in people with Brain Tumor, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
1. To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Dexmedetomidine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2025to 31 Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old and less than 80 years old
- receive brain tumor surgery with ASA II~III.
Who cannot join
- under the age of 18 or over 80
- consciousness unclear
- those who have not signed a consent form
- those with high anesthesia risk ASA IV or higher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Zhi-Fu Wu, +88675978215
About this study
Official title: Exploring the Effects of Perioperative Dexmedetomidine on the Incidence of Postoperative Delirium, Acute and Chronic Pain, and Sleep Quality in Patients Undergoing Brain Tumor Surgery
- To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery.
- To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain.
- To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth, hemodynamics and reduce the dose of anesthetics, thereby accelerating patient recovery.
- Conditions
- Brain Tumor
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- brain tumor, postoperative delirium
- Medical subject headings
- Brain Neoplasms, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
During the surgery, target-controlled infusion (TCI) pumps were used, employing the Dyck model for continuous infusion of propofol, with the target plasma concentration maintained at 0.2 ng/ml. Postoperatively, propofol was infused at a rate of 0.2-0.4 mcg/kg/hr according to the intensive care unit's protocol, until the patient had the endotracheal tube removed.
Normal SalineDrug
During the surgery, equal volumes of saline were injected. After the surgery, the patient was transferred to the intensive care unit, where propofol was continuously infused at a rate of 0.2-0.4 mcg/kg/hr according to the ICU protocol, until the endotracheal tube was removed.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | brain tumor postoperative Receives: Drug: Dexmedetomidine; Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and Documentation of Delirium
Confusion assessment method in intensive care unit using questionnaire(CAM-ICU), The evaluation method is "yes" or "no," with "no" being the best.
Measured: Perioperative
Assessment and Documentation of Delirium
3-minute diagnostic interview with confusion assessment method (3D-CAM), The evaluation method is "yes" or "no," with "no" being the best.
Measured: Perioperative
Assessment and Documentation of Delirium
Richmond Agitation-Sedation Scale (RASS) ,The score ranges from +4 to -5, with +4 being the best.
Measured: Perioperative
Assessment and Documentation of Delirium
Numerical Rating Scale (NRS) ,The score ranges from 0 to 10, with 0 being the best.
Measured: 1 to 3 days post-surgery.
Assessment and Documentation of Delirium
Richards Campbell Sleep Questionnaire (RCSQ) ,The score ranges from 0 to 100, with 100 being the best.
Measured: 1 to 3 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863064
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240297
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Perioperative Dexmedetomidine on the Incidence of Postoperative Delirium, Acute and Chronic Pain, and Sleep Quality in Patients Undergoing Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT06863064
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240297
- Conditions
- Brain Tumor
- Keywords
- brain tumor, postoperative delirium
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Mar 2025 (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.
- To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery.
- To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain.
- To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth, hemodynamics and reduce the dose of anesthetics, thereby accelerating patient recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Experimental | Drug: Dexmedetomidine, Drug: Normal Salinebrain tumor postoperative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old and less than 80 years old
- receive brain tumor surgery with ASA II~III.
Key exclusion criteria (4 listed)
- under the age of 18 or over 80
- consciousness unclear
- those who have not signed a consent form
- those with high anesthesia risk ASA IV or higher
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 |
|---|---|---|
| DexmedetomidineDuring the surgery, target-controlled infusion (TCI) pumps were used, employing the Dyck model for continuous infusion of propofol, with the target plasma concentration maintained at 0.2 ng/ml. Postoperatively, propofol was infused at a rate of 0.2-0.4 mcg/kg/hr according to the intensive care unit's protocol, until the patient had the endotracheal tube removed. | Drug | Participant Group |
| Normal SalineDuring the surgery, equal volumes of saline were injected. After the surgery, the patient was transferred to the intensive care unit, where propofol was continuously infused at a rate of 0.2-0.4 mcg/kg/hr according to the ICU protocol, until the endotracheal tube was removed. | Drug | Participant Group |
Primary outcome
Assessment and Documentation of Delirium
Time frame: Perioperative
Confusion assessment method in intensive care unit using questionnaire(CAM-ICU), The evaluation method is "yes" or "no," with "no" being the best.
Assessment and Documentation of Delirium
Time frame: Perioperative
3-minute diagnostic interview with confusion assessment method (3D-CAM), The evaluation method is "yes" or "no," with "no" being the best.
Assessment and Documentation of Delirium
Time frame: Perioperative
Richmond Agitation-Sedation Scale (RASS) ,The score ranges from +4 to -5, with +4 being the best.
Assessment and Documentation of Delirium
Time frame: 1 to 3 days post-surgery.
Numerical Rating Scale (NRS) ,The score ranges from 0 to 10, with 0 being the best.
Assessment and Documentation of Delirium
Time frame: 1 to 3 days post-surgery.
Richards Campbell Sleep Questionnaire (RCSQ) ,The score ranges from 0 to 100, with 100 being the best.
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 7 Mar 2025.
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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.
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 Normal Saline in people with Brain Tumor, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Mar 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 Taiwan. 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?
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 Zhi-Fu Wu (886+75978215, aneswu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment and Documentation of Delirium (time frame: Perioperative). The study lists 5 primary outcomes in all. 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 7 Mar 2025.