Involuntary MovementsNCT03489785
Predictive Factors of Unpredicted Movement in Motor Evoked Potential
An observational study of Involuntary Movements and Brain Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to identify the predictive factors of unpredicted movement in motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult patients undergoing brain surgery. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Involuntary Movements, Brain Surgery
- How many people
- 850 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2003to 31 Dec 2018
- Phase
- Observational
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital were included in this study.
Who may be able to join
- From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital.
Who cannot join
- Age : 18 or younger and 75 or older
- Anesthesiologists physical status classes III or more
- body mass index(BMI) < 18.5 kg/m^2 or BMI > 25 kg/m^2
- Patients who received medications that affect muscle relaxation recovery other than anticonvulsants
- OT/PT > 40 IU/L, Cr > 1.4 mg/dl
- Moderate to severe respiratory or heart disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu
Soowon Lee, Resident, 82-10-4711-5380, superiorvii@gmail.com
About this study
Official title: Predictive Factors of Unpredicted Movement in Motor Evoked Potential During Intraoperative Neurophysiologic Monitoring in Adult Patients Undergoing Brain Surgery.
The purpose of this study was to identify the predictive factors of unpredicted movement in motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult patients undergoing brain surgery.
Read the detailed description
Despite advances in neuroendovascular techniques, several complications can occur by brain urgery. Therefore, for neurosurgeons and anesthesiologists, it is a major concern to describe and monitor surgical lesion for maintaining structural and functional integrity as well as achieving maximal cytoreduction in lesion, and modifying the management of patients on the process of surgery. For example, microvascular Doppler sonography, indocyanine green aniography, intraoperative digital subtraction angiography, and intraoperative neurophysiologic monitoring (IONM) are used for this purpose.
The incidence of unpredictable and unacceptable movement is relative low. However, the results are so horrendous that they can cause injuries in site of rigid pin fixation of the head, cervical spine injuries, excessive surgical field movement, and deterioration of surgical outcome. However, risk factors associated with unpredictable and unacceptable movement remain unclear. Therefore, the aim of this retrospective study was to evaluate risk factors associated with unpredictable and unacceptable movement in the patients who underwent brain surgery with MEP monitoring under general anesthesia while using neuromuscular blocking agent.
The investigators recorded demographic data including age in years, sex, height in meters, weight in kilograms, body mass index (BMI in kg/m^2), ASA physical status class, diagnosed disease, performed surgical procedure, duration of anesthesia in minutes, duration of surgery in minutes, underlying disease (e.g. hypertension, diabetes, neurologic disease, respiratory disease), medications. Laboratory data was also collected including arterial blood gas analysis, hematocrit, hemoglobin, sodium, potassium, ionized calcium, ionized magnesium, and lactate. Unpredictable and unacceptable movement was defined as either the dangerous gross movement requiring the increase the continuous infusion rate of rocuronium in view of the surgeon, anesthesiologist, and neurophysiologic specialist or the shake of the surgical field requiring the increase the continuous infusion rate of rocuronium.
- Conditions
- Involuntary Movements, Brain Surgery
- Keywords
- Predicted factor, Motor Evoked Potentials
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Movement | If there is unexpected movement | |
| No movement | If there is no unexpected movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors of unpredicted movement
The investigators retrospectively compare the data of patients with and without unpredictable and unacceptable movement during surgery. For continuous variables, values were compared using the independent t-test. Differences in proportions were compared using chi-square test. Variables with P-values < 0.05 in the primary test were selected and univariate binary logistic regression analyses were conducted to identify the factors predictive of an unpredictable and unacceptable movement. P-value < 0.05 was considered statistically significant.
Measured: during brain surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Jun 2003
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Involuntary MovementsStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489785
- Sponsor's protocol ID
- B-1801-444-102
- Status last verified
- Jan 2018
- First submitted
- 7 Mar 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Unpredicted Movement in Motor Evoked Potential During Intraoperative Neurophysiologic Monitoring in Adult Patients Undergoing Brain Surgery.
- ClinicalTrials.gov ID
- NCT03489785
- Acronym / sponsor ID
- B-1801-444-102
- Conditions
- Involuntary Movements, Brain Surgery
- Keywords
- Predicted factor, Motor Evoked Potentials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2003 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 5 Apr 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.
The purpose of this study was to identify the predictive factors of unpredicted movement in motor evoked potential (MEP) during intraoperative neurophysiologic monitoring in adult patients undergoing brain surgery.
Detailed description
Despite advances in neuroendovascular techniques, several complications can occur by brain urgery. Therefore, for neurosurgeons and anesthesiologists, it is a major concern to describe and monitor surgical lesion for maintaining structural and functional integrity as well as achieving maximal cytoreduction in lesion, and modifying the management of patients on the process of surgery. For example, microvascular Doppler sonography, indocyanine green aniography, intraoperative digital subtraction angiography, and intraoperative neurophysiologic monitoring (IONM) are used for this purpose.
The incidence of unpredictable and unacceptable movement is relative low. However, the results are so horrendous that they can cause injuries in site of rigid pin fixation of the head, cervical spine injuries, excessive surgical field movement, and deterioration of surgical outcome. However, risk factors associated with unpredictable and unacceptable movement remain unclear. Therefore, the aim of this retrospective study was to evaluate risk factors associated with unpredictable and unacceptable movement in the patients who underwent brain surgery with MEP monitoring under general anesthesia while using neuromuscular blocking agent.
The investigators recorded demographic data including age in years, sex, height in meters, weight in kilograms, body mass index (BMI in kg/m^2), ASA physical status class, diagnosed disease, performed surgical procedure, duration of anesthesia in minutes, duration of surgery in minutes, underlying disease (e.g. hypertension, diabetes, neurologic disease, respiratory disease), medications. Laboratory data was also collected including arterial blood gas analysis, hematocrit, hemoglobin, sodium, potassium, ionized calcium, ionized magnesium, and lactate. Unpredictable and unacceptable movement was defined as either the dangerous gross movement requiring the increase the continuous infusion rate of rocuronium in view of the surgeon, anesthesiologist, and neurophysiologic specialist or the shake of the surgical field requiring the increase the continuous infusion rate of rocuronium.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Movement | – | –If there is unexpected movement |
| No movement | – | –If there is no unexpected movement |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital were included in this study.
Key inclusion criteria (1 listed)
- From June 2003 to August 2017, patients who underwent motor-evoked potential monitoring during brain surgery under partial neuromuscular relaxation at the Seoul National University Bundang Hospital.
Key exclusion criteria (6 listed)
- Age : 18 or younger and 75 or older
- Anesthesiologists physical status classes III or more
- body mass index(BMI) < 18.5 kg/m^2 or BMI > 25 kg/m^2
- Patients who received medications that affect muscle relaxation recovery other than anticonvulsants
- OT/PT > 40 IU/L, Cr > 1.4 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive factors of unpredicted movement
Time frame: during brain surgery
The investigators retrospectively compare the data of patients with and without unpredictable and unacceptable movement during surgery. For continuous variables, values were compared using the independent t-test. Differences in proportions were compared using chi-square test. Variables with P-values < 0.05 in the primary test were selected and univariate binary logistic regression analyses were conducted to identify the factors predictive of an unpredictable and unacceptable movement. P-value < 0.05 was considered statistically significant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Involuntary Movements and Brain Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 South Korea. 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.
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 Soowon Lee (82-10-4711-5380, superiorvii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive factors of unpredicted movement (time frame: during brain surgery). 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 30 Apr 2018.