Central Nervous System DiseasesPhase 4NCT01445639
Dexmedetomidine in Patients After Intracranial Surgery
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Central Nervous System Diseases, run by Capital Medical University at 1 site in China.
Trial summary
Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Diseases
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Feb 2013
- Phase
- Phase 4
- 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
- Adult patients after intracranial surgery with delayed extubation
Who cannot join
- emergency operation
- brain stem operation
- preoperative consciousness disorders or epilepsy
- bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion
- patients enrolled in another trial
Trial locations and contacts
1 site in 1 country.
China1 site
Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
Official title: Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)
Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. No study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. The primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.
Read the detailed description
The PASTrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. The study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. In dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. In control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. The patient's level of sedation is assessed by Sedation-Agitation Scale (SAS) per hour. Midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as SAS above 4. The study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.
- Conditions
- Central Nervous System Diseases
- Being tested
- Dexmedetomidine, Normal saline
- Keywords
- dexmedetomidine, sedation, neurosurgery, postoperative care
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively
Normal salineDrug
as placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage of hours of optimal sedation.
Optimal sedation is defined as SAS score 4.
Measured: 24 hours postoperative
Secondary outcomes (1)
Percentage of patients with agitation and receiving additional sedatives.
Agitation is defined as SAS above 4. Patients are given midazolam as agitation.
Measured: During the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Study chair, Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445639
- Sponsor's protocol ID
- BTH-NICU-2011-02
- Other IDs
- 2009-03-28
- Status last verified
- Jan 2014
- First submitted
- 30 Sep 2011
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)
- ClinicalTrials.gov ID
- NCT01445639
- Acronym / sponsor ID
- BTH-NICU-2011-02
- Conditions
- Central Nervous System Diseases
- Keywords
- dexmedetomidine, sedation, neurosurgery, postoperative care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Oct 2011 (estimated)
- 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.
Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. No study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. The primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.
Detailed description
The PASTrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. The study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. In dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. In control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. The patient's level of sedation is assessed by Sedation-Agitation Scale (SAS) per hour. Midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as SAS above 4. The study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine |
| Placebo group | Placebo comparator | Drug: Normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients after intracranial surgery with delayed extubation
Key exclusion criteria (5 listed)
- emergency operation
- brain stem operation
- preoperative consciousness disorders or epilepsy
- bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion
- patients enrolled in another trial
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 |
|---|---|---|
| DexmedetomidineIntravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively | Drug | Dexmedetomidine group |
| Normal salineas placebo | Drug | Placebo group |
Primary outcome
Mean percentage of hours of optimal sedation.
Time frame: 24 hours postoperative
Optimal sedation is defined as SAS score 4.
1 secondary outcome
Percentage of patients with agitation and receiving additional sedatives.
Time frame: During the first 24 hours postoperatively
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 Jan 2014.
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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.
Jian-Xin Zhou, MD study chair
Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Normal saline in people with Central Nervous System Diseases, run by Capital Medical University 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 1 inclusion and 5 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 Jan 2014. 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.
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?
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?
Mean percentage of hours of optimal sedation. (time frame: 24 hours postoperative). 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 28 Jan 2014.