ChildrenNCT02261675
Reduction in MACbar of Sevoflurane by Dexmedetomidine in Children
A study testing dexmedetomidine in people with Children, run by Cai Li.
Trial summary
The study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Children
- What is being tested?
- dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2014
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 2 to 6 yr
- American Society of anesthesiologists I or II
- scheduled to have general anesthesia and to have skin incisions on the abdomen
Who cannot join
- anemia or abnormal preoperative electrolyte concentrations
- a history of cardiovascular or central nervous system diseases
- a history of pulmonary disease
- known hepatic or renal disease
- a body weight exceeding 50% of the upper limit of ideal body weight for height
- taking drugs with cardiovascular or central nervous system effects
Show all 11Show fewer
- use of any experimental drug within the past 30 days
- allergy to any drug that may be administered during the study
- exposure to general anesthesia within the previous 7 days
- second- or third-degree atrioventricular block
- taking drugs preoperatively that would interfere with MAC determination(e.g.,opioids or sedatives)
About this study
Official title: Dexmedetomidine Augments Block of Sympathetic Responses to Skin Incision During Sevoflurane Anesthesia in Children
The study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of anesthetic potency.
Read the detailed description
The investigators observed the effects of different doses of dexmedetomidine on the minimum alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in 50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric patients.
- Conditions
- Children
- Being tested
- dexmedetomidine
- Keywords
- dexmedetomidine, sevoflurane, MAC bar, drug interaction, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called precedex
children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | children undergoing selective lower abdominal surgery received saline before induction |
| D1 group | Experimental | children undergoing selective lower abdominal surgery received a bolus dose of 0.5 µg/kg dexmedetomidine followed by a continuous infusion of 0.5 µg/kg /h before induction Receives: Drug: dexmedetomidine |
| D2 group | Experimental | children undergoing selective lower abdominal surgery received a bolus dose of 1.0µg/kg dexmedetomidine followed by a continuous infusion of 1.0 µg/kg /h before induction Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)
A predetermined steady-state end-tidal sevoflurane concentration(4%) was maintained for at least 15 min before skin incision.we observed the change in Mean Blood Pressure or Heart rate to determined the next end-tidal sevoflurane concentration.Followed the modified Dixon up and down method to obtain MACBAR of every child.The MACBAR of sevoflurane and its 95% confidence interval were calculated by Sum Average method.
Measured: at once before incision and 5 min period after incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cai Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cai Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xuan Ke Liu, Ph.d, Principal investigator, Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261675
- Sponsor's protocol ID
- Macbar DEX
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.
PubMed 14739797
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Augments Block of Sympathetic Responses to Skin Incision During Sevoflurane Anesthesia in Children
- ClinicalTrials.gov ID
- NCT02261675
- Acronym / sponsor ID
- Macbar DEX
- Conditions
- Children
- Keywords
- dexmedetomidine, sevoflurane, MAC bar, drug interaction, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cai LiUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Oct 2014 (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 study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of anesthetic potency.
Detailed description
The investigators observed the effects of different doses of dexmedetomidine on the minimum alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in 50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric patients.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –children undergoing selective lower abdominal surgery received saline before induction |
| D1 group | Experimental | Drug: dexmedetomidinechildren undergoing selective lower abdominal surgery received a bolus dose of 0.5 µg/kg dexmedetomidine followed by a continuous infusion of 0.5 µg/kg /h before induction |
| D2 group | Experimental | Drug: dexmedetomidinechildren undergoing selective lower abdominal surgery received a bolus dose of 1.0µg/kg dexmedetomidine followed by a continuous infusion of 1.0 µg/kg /h before induction |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged 2 to 6 yr
- American Society of anesthesiologists I or II
- scheduled to have general anesthesia and to have skin incisions on the abdomen
Key exclusion criteria (11 listed)
- anemia or abnormal preoperative electrolyte concentrations
- a history of cardiovascular or central nervous system diseases
- a history of pulmonary disease
- known hepatic or renal disease
- a body weight exceeding 50% of the upper limit of ideal body weight for height
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 |
|---|---|---|
| dexmedetomidineAlso: precedexchildren received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision. | Drug | D1 group, D2 group |
Primary outcome
the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)
Time frame: at once before incision and 5 min period after incision
A predetermined steady-state end-tidal sevoflurane concentration(4%) was maintained for at least 15 min before skin incision.we observed the change in Mean Blood Pressure or Heart rate to determined the next end-tidal sevoflurane concentration.Followed the modified Dixon up and down method to obtain MACBAR of every child.The MACBAR of sevoflurane and its 95% confidence interval were calculated by Sum Average method.
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 10 Oct 2014.
- Results publication: PubMed 14739797Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.
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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.
Xuan Ke Liu, Ph.d principal investigator
Departmeng of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine in people with Children, run by Cai Li.
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 11 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 10 Oct 2014. 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.
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 end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR) (time frame: at once before incision and 5 min period after incision). 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 NCT02261675, which also lists 1 linked publication.
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 10 Oct 2014.