Procedural PainPhase 4NCT06837818
To Explore the Optimal Dose of Dexmedetomidine for Skull Pin Fixation in Intracranial Surgery
A Phase 4 study testing Dexmedetomidine in people with Procedural Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
Skull pin fixation is commonly used in intracranial surgery, which can increase the surgical field of view. Because skull pin fixation is a very irritating and painful medical treatment, it often results in tachycardia (>150-160 beats per min, bpm) and high blood pressure (BP) (>200/120 mmHg). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Procedural Pain
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Phase 4
- 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
- Must be at least 18 years old and less than 80 years old, with ASA I~III. Patients who are expected to undergo intracranial surgery for skull pin fixation.
Who cannot join
- Patients under the age of 18, patients over 80, those who have not signed a consent form, those with ASA class IV or higher, those who are allergic to dexmedetomidine or propofol or remifentanil, sever bradycardia (HR<40 bpm), hypotension (<90/60 mmHg) and hypertension crisis (180/110 mmHg), and emergency patients, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Skull pin fixation is commonly used in intracranial surgery, which can increase the surgical field of view. Because skull pin fixation is a very irritating and painful medical treatment, it often results in tachycardia (>150-160 beats per min, bpm) and high blood pressure (BP) (>200/120 mmHg). Many strategies to reduce this painful stimulation include oral gabapentin, local injection of local anesthetics, scalp nerve blockade, and deepening the depth of anesthesia. Oral gabapentin must take 2 hr before surgery with many adverse effects such as nausea and vomiting. Local injection of local anesthetics and scalp nerve blockade require injections by neurosurgeons. Due to the manpower and time constraints, neurosurgeons cannot perform the two techniques. Therefore, it depends on anesthesiologists to prescribe more anesthetics to attenuate this intensity painful stimulation. Usually anesthesiologists will give propofol, opioids (fentanyl, alfentanil or remifentanil), α2 agonist (dexmedetomidine or clonidine), add inhalation anesthetics (sevoflurane or desflurane), and finally even use b-blocker to reduce hemodynamic instability (hyperdynamics).
Dexmedetomidine mainly produces a sedative effect by activating α2 adrenergic receptors in the central nervous system. Its α2:α1 ratio is 1620:1, showing high affinity for α2 receptors. Unlike other hypnotic drugs during death, dexmedetomidine keeps the patient in an awakenable state and does not affect respiratory function during sedation. Therefore, general anesthesia can be enhanced, providing sedation and analgesia and improving sleep quality.
Read more
Target-controlled infusion (TCI) pump systems can automatically adjust drug infusion rates based on the patient's weight, age, and other physiological parameters to achieve more precise drug concentrations. It can maintain a stable drug concentration and reduce the impact of drug fluctuations on patients, especially when long-term anesthesia or sedation is required. Therefore, using a TCI pump system to administer dexmedetomidine can ensure that the concentration we want can be accurately achieved when performing skull pin fixation. Our hospital has routinely used the Dyck mode of the TCI pump system to infuse dexmedetomidine 0.2-0.4 ng/ml during intracranial surgery.
In view of this, we wanted to observe patients undergoing intracranial surgery with skull pin fixation using the Dyck mode by the TCI pump system under the monitoring of analgesic nociceptive index and hemodynamics. In order to find out the most appropriate dexmedetomidine concentration during skull pin fixation to reduce hemodynamic fluctuations and insufficient pain management as a basis for future anesthesia.
- Conditions
- Procedural Pain
- Being tested
- Dexmedetomidine
- Keywords
- Skull pin fixation, dexmedetomidine, Target-controlled infusion
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
The first patient was started on dexmedetomidine Cp 0.4 ng/ml, 2 minutes before the procedure, and the up and down method was used, with the Cp of dexmedetomidine adjusted to 0.05 ng/ml each time. The analgesia nociception index (ANI) during skull pin fixation is lower than (<) 30 and the heart rate (HR) and arterial blood pressure (ABP) exceed (>) 20% of the baseline (or the HR is >100 bpm and the ABP is >180/100 mmHg), indicating insufficient analgesia or hemodynamics (failure). If the patient is failure for the procedure, increase the Cp by 0.05 ng/ml for the next patient; the ANI is higher than or equal to (≥30) and the HR and ABP do not exceed 20% of the baseline or the HR is ≤100 bpm and the ABP is ≤180 /100 mmHg) indicates that the analgesia and hemodynamic stability are acceptable (success), and the next patient will be adjusted downward by 0.05 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Experimental | skull pin fixation Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% effect concentration of dexmedetomidine
50% effect concentration of dexmedetomidine will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
Measured: up to 15 minutes (peri-fixation period)
95% effect concentration of dexmedetomidine
95% effect concentration of dexmedetomidine will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
Measured: up to 15 minutes (peri-fixation period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837818
- Sponsor's protocol ID
- KMUHIRB-F(I)-20250016
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Optimal Dose of Dexmedetomidine for Skull Pin Fixation in Intracranial Surgery
- ClinicalTrials.gov ID
- NCT06837818
- Acronym / sponsor ID
- KMUHIRB-F(I)-20250016
- Conditions
- Procedural Pain
- Keywords
- Skull pin fixation, dexmedetomidine, Target-controlled infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 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.
Skull pin fixation is commonly used in intracranial surgery, which can increase the surgical field of view. Because skull pin fixation is a very irritating and painful medical treatment, it often results in tachycardia (>150-160 beats per min, bpm) and high blood pressure (BP) (>200/120 mmHg). Many strategies to reduce this painful stimulation include oral gabapentin, local injection of local anesthetics, scalp nerve blockade, and deepening the depth of anesthesia. Oral gabapentin must take 2 hr before surgery with many adverse effects such as nausea and vomiting. Local injection of local anesthetics and scalp nerve blockade require injections by neurosurgeons. Due to the manpower and time constraints, neurosurgeons cannot perform the two techniques. Therefore, it depends on anesthesiologists to prescribe more anesthetics to attenuate this intensity painful stimulation. Usually anesthesiologists will give propofol, opioids (fentanyl, alfentanil or remifentanil), α2 agonist (dexmedetomidine or clonidine), add inhalation anesthetics (sevoflurane or desflurane), and finally even use b-blocker to reduce hemodynamic instability (hyperdynamics).
Dexmedetomidine mainly produces a sedative effect by activating α2 adrenergic receptors in the central nervous system. Its α2:α1 ratio is 1620:1, showing high affinity for α2 receptors. Unlike other hypnotic drugs during death, dexmedetomidine keeps the patient in an awakenable state and does not affect respiratory function during sedation. Therefore, general anesthesia can be enhanced, providing sedation and analgesia and improving sleep quality.
Target-controlled infusion (TCI) pump systems can automatically adjust drug infusion rates based on the patient's weight, age, and other physiological parameters to achieve more precise drug concentrations. It can maintain a stable drug concentration and reduce the impact of drug fluctuations on patients, especially when long-term anesthesia or sedation is required. Therefore, using a TCI pump system to administer dexmedetomidine can ensure that the concentration we want can be accurately achieved when performing skull pin fixation. Our hospital has routinely used the Dyck mode of the TCI pump system to infuse dexmedetomidine 0.2-0.4 ng/ml during intracranial surgery.
In view of this, we wanted to observe patients undergoing intracranial surgery with skull pin fixation using the Dyck mode by the TCI pump system under the monitoring of analgesic nociceptive index and hemodynamics. In order to find out the most appropriate dexmedetomidine concentration during skull pin fixation to reduce hemodynamic fluctuations and insufficient pain management as a basis for future anesthesia.
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: Dexmedetomidineskull pin fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be at least 18 years old and less than 80 years old, with ASA I~III. Patients who are expected to undergo intracranial surgery for skull pin fixation.
Key exclusion criteria (1 listed)
- Patients under the age of 18, patients over 80, those who have not signed a consent form, those with ASA class IV or higher, those who are allergic to dexmedetomidine or propofol or remifentanil, sever bradycardia (HR<40 bpm), hypotension (<90/60 mmHg) and hypertension crisis (180/110 mmHg), and emergency patients, etc.
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 first patient was started on dexmedetomidine Cp 0.4 ng/ml, 2 minutes before the procedure, and the up and down method was used, with the Cp of dexmedetomidine adjusted to 0.05 ng/ml each time. The analgesia nociception index (ANI) during skull pin fixation is lower than (<) 30 and the heart rate (HR) and arterial blood pressure (ABP) exceed (>) 20% of the baseline (or the HR is >100 bpm and the ABP is >180/100 mmHg), indicating insufficient analgesia or hemodynamics (failure). If the patient is failure for the procedure, increase the Cp by 0.05 ng/ml for the next patient; the ANI is higher than or equal to (≥30) and the HR and ABP do not exceed 20% of the baseline or the HR is ≤100 bpm and the ABP is ≤180 /100 mmHg) indicates that the analgesia and hemodynamic stability are acceptable (success), and the next patient will be adjusted downward by 0.05 ng/ml. | Drug | Participant Group |
Primary outcome
50% effect concentration of dexmedetomidine
Time frame: up to 15 minutes (peri-fixation period)
50% effect concentration of dexmedetomidine will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
95% effect concentration of dexmedetomidine
Time frame: up to 15 minutes (peri-fixation period)
95% effect concentration of dexmedetomidine will be recorded at 2 mins before fixation, during fixation, 5 mins after fixation, and 15 mins after fixation.
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 20 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Procedural Pain, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 1 inclusion and 1 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MD (+886 7312110, aneswu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% effect concentration of dexmedetomidine (time frame: up to 15 minutes (peri-fixation period)). The study lists 2 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 20 Feb 2025.