AnaesthesiaPhase 4NCT01142635
Electromyographic (EMG) on the Anaesthesia Monitor
A Phase 4 study testing Rocuronium bromide in people with Anaesthesia, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Rocuronium bromide
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2009to Mar 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females giving informed consent
- age range 18-65 years
- elective surgery: gynaecological
- general anaesthesia
- ASA classification 1 or 2
Who cannot join
- pregnancy
- body mass index > 30
- disease affecting CNS
- overuse of alcohol
- drug abuse
- unability to understand, read or use Finnish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Appearance of Electromyography on the Anaesthesia Monitor.
Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.
Read the detailed description
Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.
- Conditions
- Anaesthesia
- Being tested
- Rocuronium bromide
- Keywords
- Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Neuromuscular blockade; rocuronium, Propofol, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium bromideDrug
Also called Esmeron
Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose
Rocuronium bromideDrug
Also called Esmeron.
Rocuronium, iv, single dose, single bolus, 1.2 mg/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
The behaviour of biosignal on the anaesthesia monitor
The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor
Measured: 30 minutes
Secondary outcomes (1)
The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation
Intubation-associated changes in the numerical values of BIS, SE, RE
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Arvi Yli-Hankala, MD, Study chair, Tampere University HospitalArvi Yli-Hankala, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142635
- Sponsor's protocol ID
- R08197M
- Other IDs
- 2008-008129-31, 2008
- Status last verified
- Jun 2010
- First submitted
- 10 Jun 2010
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Appearance of Electromyography on the Anaesthesia Monitor.
- ClinicalTrials.gov ID
- NCT01142635
- Acronym / sponsor ID
- R08197M
- Conditions
- Anaesthesia
- Keywords
- Electroencephalogram, Electromyogram, Entropy Index, Bispectral Index, Neuromuscular blockade; rocuronium, Propofol, Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jun 2010 (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.
Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.
Detailed description
Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- females giving informed consent
- age range 18-65 years
- elective surgery: gynaecological
- general anaesthesia
- ASA classification 1 or 2
Key exclusion criteria (6 listed)
- pregnancy
- body mass index > 30
- disease affecting CNS
- overuse of alcohol
- drug abuse
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 |
|---|---|---|
| Rocuronium bromideAlso: EsmeronRocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose | Drug | – |
| Rocuronium bromideAlso: Esmeron.Rocuronium, iv, single dose, single bolus, 1.2 mg/kg | Drug | – |
Primary outcome
The behaviour of biosignal on the anaesthesia monitor
Time frame: 30 minutes
The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor
1 secondary outcome
The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation
Time frame: 30 min
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 11 Jun 2010.
Related trials for Anaesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Arvi Yli-Hankala, MD study chair
Tampere University Hospital
Arvi Yli-Hankala, MD principal investigator
Tampere University Hospital
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 Rocuronium bromide in people with Anaesthesia, run by Tampere University Hospital at 1 site in Finland.
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 5 inclusion and 6 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 11 Jun 2010. 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 Finland. 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?
The behaviour of biosignal on the anaesthesia monitor (time frame: 30 minutes). 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 11 Jun 2010.