Intracranial AneurysmsPhase 4NCT01722409
A Better Choice for Patients Undergoing Endovascular Coil Embolization
A Phase 4 study testing sevoflurane and 0.5 μg/kg dexmedetomidine and sevoflurane and 1 μg/kg dexmedetomidine in people with Intracranial Aneurysms, run by China Medical University, China at 1 site in China.
Trial summary
The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- sevoflurane and 0.5 μg/kg dexmedetomidine and sevoflurane and 1 μg/kg dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Feb 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:18-65 years old ASA I or ASA II patients undergoing ECE treatment for intracranial aneurysms were included.
Exclusion Criteria:Patients were excluded based on the following parameters: older than 65 yrs, a history of mental illness, recent use of sedatives or analgesics and with sensation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization
The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
- Conditions
- Intracranial Aneurysms
- Being tested
- sevoflurane and 0.5 μg/kg dexmedetomidine, sevoflurane and 1 μg/kg dexmedetomidine
- Keywords
- dexmedetomidine, endovascular coil embolization
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevoflurane and 0.5 μg/kg dexmedetomidineDrug
Also called DEX1
After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
sevoflurane and 1 μg/kg dexmedetomidineDrug
Also called DEX2
After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane and saline infusion | No intervention | After induction of general anesthesia, Group S received a placebo infusion of normal saline. |
| sevoflurane and 0.5 μg/kg dexmedetomidine | Experimental | After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes. Receives: Drug: sevoflurane and 0.5 μg/kg dexmedetomidine |
| sevoflurane and 1 μg/kg dexmedetomidine | Experimental | After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes. Receives: Drug: sevoflurane and 1 μg/kg dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.
Measured: At the end of the operation and 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
- Investigators
- Hong Ma, M.D.,PhD., Study chair, Dept. of Anesthesiology, the First Hospital of CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722409
- Sponsor's protocol ID
- 20121009
- Status last verified
- Oct 2013
- First submitted
- 3 Nov 2012
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevoflurane, Laryngeal Mask Airway and Single-dose Dexmedetomidine: A Better Choice for Patients Undergoing Endovascular Coil Embolization
- ClinicalTrials.gov ID
- NCT01722409
- Acronym / sponsor ID
- 20121009
- Conditions
- Intracranial Aneurysms
- Keywords
- dexmedetomidine, endovascular coil embolization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Nov 2012 (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.
The investigators designed a double-blind, randomized placebo-controlled study to determine the effects of dexmedetomidine on the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sevoflurane and saline infusion | No intervention | –After induction of general anesthesia, Group S received a placebo infusion of normal saline. |
| sevoflurane and 0.5 μg/kg dexmedetomidine | Experimental | Drug: sevoflurane and 0.5 μg/kg dexmedetomidineAfter induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes. |
| sevoflurane and 1 μg/kg dexmedetomidine | Experimental | Drug: sevoflurane and 1 μg/kg dexmedetomidineAfter induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| sevoflurane and 0.5 μg/kg dexmedetomidineAlso: DEX1After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes. | Drug | sevoflurane and 0.5 μg/kg dexmedetomidine |
| sevoflurane and 1 μg/kg dexmedetomidineAlso: DEX2After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes. | Drug | sevoflurane and 1 μg/kg dexmedetomidine |
Primary outcome
Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization.
Time frame: At the end of the operation and 24 hours later
The time from termination of the general anesthetic to the time that the patient's eyes opened. Anesthesiologists collected information on emergence agitation, postoperative nausea and vomiting for 24 hours after the surgery.
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 25 Jun 2015.
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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.
Hong Ma, M.D.,PhD. study chair
Dept. of Anesthesiology, the First Hospital of CMU
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 sevoflurane and 0.5 μg/kg dexmedetomidine and sevoflurane and 1 μg/kg dexmedetomidine in people with Intracranial Aneurysms, run by China Medical University, China 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?
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 25 Jun 2015. 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. 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?
Observing the recovery characteristics of patients who were scheduled to undergo endovascular coil embolization. (time frame: At the end of the operation and 24 hours later). 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 25 Jun 2015.