Inhalation AnesthesiaPhase 4NCT03394430
Comparison of Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction
A Phase 4 study testing Midazolam and Dexmedetomidine in people with Inhalation Anesthesia, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Induction with high sevoflurane concentrations may trigger epileptiform electroencephalographic activity without motor or cardiovascular manifestations in healthy patients. No other symptoms were associated in this series, and only electroencephalographic monitoring allowed the diagnosis. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Inhalation Anesthesia
- What is being tested?
- Midazolam and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Feb 2019
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status 1-2
- Scheduled for general anesthesia
Who cannot join
- Patients with a history of neurological, mental illnes
- Patients with a history of congenital heart disease
- Patients with a history of allergies to related drugs
Trial locations and contacts
1 site in 1 country.
Chenyu Jin contact
China1 site
Shanghai Ninth People's Hospital,Affililated to Shanghai Jiaotong University School of Medicine
Shanghai
Yu Sun, MD,PhD, 0086-136-1189-5542, dr_sunyu@163.com
Chenyu Jin
About this study
Official title: Comparison of Intranasal Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction in Children
Induction with high sevoflurane concentrations may trigger epileptiform electroencephalographic activity without motor or cardiovascular manifestations in healthy patients. No other symptoms were associated in this series, and only electroencephalographic monitoring allowed the diagnosis. Midazolam and dexmedetomidine are sedatives commonly used in children before surgery. Although the mechanisms are different, both have been reported in antiepileptic effects.
This study was designed to compare the effects between intranasal midazolam or dexmedetomidine on epileptiform EEG during sevoflurane mask induction in children. Anaesthesia was induced with 8% sevoflurane. The patients were randomly assigned to Group A (n=15, preoperative intranasal normal saline), Group B (n=15, preoperative intranasal 0.25mg/kg midazolam), and Group C (n=15, preoperative intranasal 1μg/kg dexmedetomidine). An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
- Conditions
- Inhalation Anesthesia
- Being tested
- Placebos, Midazolam, Dexmedetomidine
- Keywords
- sevoflurane, epileptiform EEG, midazolam, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
Patients in Group A receive intranasal normal saline before anesthesia. Anaesthesia was induced with 8% sevoflurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
MidazolamDrug
Patients in Group B receive intranasal 0.25mg/kg midazolam before anesthesia. Anaesthesia was induced with 8% sevoflurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
DexmedetomidineDrug
Patients in Group C receive intranasal 1μg/kg dexmedetomidine before anesthesia. Anaesthesia was induced with 8% sevoflurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Not described Receives: Drug: Placebos |
| Group B | Experimental | Not described Receives: Drug: Midazolam |
| Group C | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of epileptiform EEG
EEG were visually analyzed off-line by a neurophysiologist familiar with anesthesia EEG and blinded to the randomization. EEG abnormalities related to epileptic features were classified according to the description of Vakkuri and Jaaskelainen, and the recommendations of Constant: spikes and spikes with slow wave complexes (SW), rhythmic polyspikes corresponding to waveforms appearing at regular intervals (RPS) and periodic epileptiform discharge (PED), which refers to periodic hypersynchronized complexes occurring bilaterally. These entire electroencephalographic phenomena were considered as epileptiform EEG if their duration was longer than three seconds.
Measured: 0 min after induction, up to 10 min
Secondary outcomes (18)
electroencephalographic changes
the delay between the start of induction and the first changes in electroencephalographic activity (appearance of β, θ, or δ rhythms)
Measured: 0 min after induction, up to 10 min
electroencephalographic changes
the occurrence of burst suppressions
Measured: 0 min after induction, up to 10 min
electroencephalographic changes
duration of suppression period, i.e. the sum of the EEG silences.
Measured: 0 min after induction, up to 10 min
hemodynamic changes
blood pressure
Measured: 1 min before induction
hemodynamic changes
heart rate
Measured: 1 min before induction
hemodynamic changes
blood pressure
Measured: during induction procedure
hemodynamic changes
heart rate
Measured: during induction procedure
hemodynamic changes
blood pressure
Measured: 2 min after induciton
hemodynamic changes
heart rate
Measured: 2 min after induciton
hemodynamic changes
blood pressure
Measured: 4 min after induciton
hemodynamic changes
heart rate
Measured: 4 min after induciton
hemodynamic changes
blood pressure
Measured: 6 min after induciton
hemodynamic changes
heart rate
Measured: 6 min after induciton
hemodynamic changes
blood pressure
Measured: 8 min after induciton
hemodynamic changes
heart rate
Measured: 8 min after induciton
hemodynamic changes
blood pressure
Measured: 10 min after induciton
hemodynamic changes
heart rate
Measured: 10 min after induciton
intubation time
from taking of the intubation device to successful intubation
Measured: 0 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation AnesthesiaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394430
- Sponsor's protocol ID
- MDZ/DEX
- Status last verified
- Feb 2018
- First submitted
- 17 Dec 2017
- Last updated
- 25 Sep 2018
- 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 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intranasal Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction in Children
- ClinicalTrials.gov ID
- NCT03394430
- Acronym / sponsor ID
- MDZ/DEX
- Conditions
- Inhalation Anesthesia
- Keywords
- sevoflurane, epileptiform EEG, midazolam, dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 9 Jan 2018 (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.
Induction with high sevoflurane concentrations may trigger epileptiform electroencephalographic activity without motor or cardiovascular manifestations in healthy patients. No other symptoms were associated in this series, and only electroencephalographic monitoring allowed the diagnosis. Midazolam and dexmedetomidine are sedatives commonly used in children before surgery. Although the mechanisms are different, both have been reported in antiepileptic effects.
This study was designed to compare the effects between intranasal midazolam or dexmedetomidine on epileptiform EEG during sevoflurane mask induction in children. Anaesthesia was induced with 8% sevoflurane. The patients were randomly assigned to Group A (n=15, preoperative intranasal normal saline), Group B (n=15, preoperative intranasal 0.25mg/kg midazolam), and Group C (n=15, preoperative intranasal 1μg/kg dexmedetomidine). An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: Placebos |
| Group B | Experimental | Drug: Midazolam |
| Group C | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status 1-2
- Scheduled for general anesthesia
Key exclusion criteria (3 listed)
- Patients with a history of neurological, mental illnes
- Patients with a history of congenital heart disease
- Patients with a history of allergies to related drugs
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 |
|---|---|---|
| PlacebosPatients in Group A receive intranasal normal saline before anesthesia. Anaesthesia was induced with 8% sevoflurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction. | Drug | Group A |
| MidazolamPatients in Group B receive intranasal 0.25mg/kg midazolam before anesthesia. Anaesthesia was induced with 8% sevoflurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction. | Drug | Group B |
| DexmedetomidinePatients in Group C receive intranasal 1μg/kg dexmedetomidine before anesthesia. Anaesthesia was induced with 8% sevoflurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction. | Drug | Group C |
Primary outcome
incidence of epileptiform EEG
Time frame: 0 min after induction, up to 10 min
EEG were visually analyzed off-line by a neurophysiologist familiar with anesthesia EEG and blinded to the randomization. EEG abnormalities related to epileptic features were classified according to the description of Vakkuri and Jaaskelainen, and the recommendations of Constant: spikes and spikes with slow wave complexes (SW), rhythmic polyspikes corresponding to waveforms appearing at regular intervals (RPS) and periodic epileptiform discharge (PED), which refers to periodic hypersynchronized complexes occurring bilaterally. These entire electroencephalographic phenomena were considered as epileptiform EEG if their duration was longer than three seconds.
18 secondary outcomes
electroencephalographic changes
Time frame: 0 min after induction, up to 10 min
electroencephalographic changes
Time frame: 0 min after induction, up to 10 min
electroencephalographic changes
Time frame: 0 min after induction, up to 10 min
hemodynamic changes
Time frame: 1 min before induction
hemodynamic changes
Time frame: 1 min before induction
hemodynamic changes
Time frame: during induction procedure
hemodynamic changes
Time frame: during induction procedure
hemodynamic changes
Time frame: 2 min after induciton
hemodynamic changes
Time frame: 2 min after induciton
hemodynamic changes
Time frame: 4 min after induciton
hemodynamic changes
Time frame: 4 min after induciton
hemodynamic changes
Time frame: 6 min after induciton
hemodynamic changes
Time frame: 6 min after induciton
hemodynamic changes
Time frame: 8 min after induciton
hemodynamic changes
Time frame: 8 min after induciton
hemodynamic changes
Time frame: 10 min after induciton
hemodynamic changes
Time frame: 10 min after induciton
intubation time
Time frame: 0 min after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
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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.
Chenyu Jin contact
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 Midazolam and Dexmedetomidine in people with Inhalation Anesthesia, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Sun, MD,PhD (0086-136-1189-5542, dr_sunyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of epileptiform EEG (time frame: 0 min after induction, up to 10 min). 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 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.