Cerebral PalsyNCT04190082
The Effect of Bispectral Index Monitoring on Recovery From Deep Sedation
An observational study of Cerebral Palsy, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study was to compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 9 Dec 2022
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: children with spastic cerebral palsy primary care clinic (rehabilitation)
Who may be able to join
- 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation
- American Society of Anesthesiologists Physical Status 1-2
Who cannot join
- Body mass index > 30 kg/m2
- unstable heart disease
- Anticipated difficult airway including congenital facial or airway anomaly
- Recent upper respiratory tract infection ( < 2 weeks)
- Gastroesophageal reflux
- Allergy history to propofol, remifentanil or any drug used during procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bispectral Index Monitoring on the Speed of Recovery From Deep Propofol Sedation in Children With Cerebral Palsy - A Randomized Controlled Trial
The purpose of this study was to compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.
Read the detailed description
After arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. Five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. Five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. Group C is monitored using UMSS(University of Michigan Sedation Scale) scores every three minutes, and group B is monitored using BIS score until deep sedation. Deep sedation is defined based on UMSS score of 3-4 and BIS score of 65 ± 5. If the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. Independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Botulinum toxin, Bispectral index monitor, Deep sedation, Recovery
- Medical subject headings
- Cerebral Palsy
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 |
|---|---|---|
| Group Control | Group who maintains deep sedation using the University of Michigan sedation scale (UMSS) score. | |
| Group BIS | Group who maintain deep sedation using Bispectral Index (BIS) score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery
Time taken to recover based on the Physiological CBD score (>12) from deep sedation
Measured: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Secondary outcomes (1)
Propofol dose
Amount of propofol to maintain deep sedation for botulinum toxin injection
Measured: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 May 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: No more participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Mee Jung, Yeungnam University College of Medicine
- Investigators
- Sung Mee Jung, MD,PhD, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190082
- Sponsor's protocol ID
- YUMC-2019-11-001
- Status last verified
- Feb 2023
- First submitted
- 4 Dec 2019
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share our data
Publications
Choudhry DK, Brenn BR. Bispectral index monitoring: a comparison between normal children and children with quadriplegic cerebral palsy. Anesth Analg. 2002 Dec;95(6):1582-5, table of contents. doi: 10.1097/00000539-200212000-00020.
PubMed 12456420Malviya S, Voepel-Lewis T, Tait AR. A comparison of observational and objective measures to differentiate depth of sedation in children from birth to 18 years of age. Anesth Analg. 2006 Feb;102(2):389-94. doi: 10.1213/01.ANE.0000184045.01780.73.
PubMed 16428530Saricaoglu F, Celebi N, Celik M, Aypar U. The evaluation of propofol dosage for anesthesia induction in children with cerebral palsy with bispectral index (BIS) monitoring. Paediatr Anaesth. 2005 Dec;15(12):1048-52. doi: 10.1111/j.1460-9592.2005.01658.x.
PubMed 16324022
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bispectral Index Monitoring on the Speed of Recovery From Deep Propofol Sedation in Children With Cerebral Palsy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04190082
- Acronym / sponsor ID
- YUMC-2019-11-001
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Botulinum toxin, Bispectral index monitor, Deep sedation, Recovery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more participants enrolled.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 9 Dec 2019 (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 compare BIS (bispectral index) monitoring and clinical sedation scale assessment on the recovery time and propofol usage from deep propofol sedation in children with cerebral palsy who received botulinum toxin injection.
Detailed description
After arrival in the preoperative holding area, children were randomly allocated into two groups using a computer-generated random assignment scheme. Five minutes before propofol sedation, remifentanil is administered intravenously at 0.025 μg / kg / min for analgesic effect and continued throughout the sedation process until just before the end of the procedure. Five minutes after remifentanil administration, 2 mg / kg of propofol mixed with 1 mg / kg of lidocaine was administered over 30 seconds, followed by continuous infusion at 100 μg / kg / min. Group C is monitored using UMSS(University of Michigan Sedation Scale) scores every three minutes, and group B is monitored using BIS score until deep sedation. Deep sedation is defined based on UMSS score of 3-4 and BIS score of 65 ± 5. If the sedation score is determined to have reached a deep sedation, a botulinum toxin injection is given by a practitioner blind to how to assess the depth of sedation. Independent investigator who is blind to group assignement assesses the oxygen saturation, respiration, and blood pressure, recovery time from sedation, and adverse events during and after sedation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | – | –Group who maintains deep sedation using the University of Michigan sedation scale (UMSS) score. |
| Group BIS | – | –Group who maintain deep sedation using Bispectral Index (BIS) score. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with spastic cerebral palsy primary care clinic (rehabilitation)
Key inclusion criteria (2 listed)
- 3-12 years old children with spastic cerebral palsy receiving botulinum toxin injection with deep sedation
- American Society of Anesthesiologists Physical Status 1-2
Key exclusion criteria (6 listed)
- Body mass index > 30 kg/m2
- unstable heart disease
- Anticipated difficult airway including congenital facial or airway anomaly
- Recent upper respiratory tract infection ( < 2 weeks)
- Gastroesophageal reflux
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
recovery
Time frame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Time taken to recover based on the Physiological CBD score (>12) from deep sedation
1 secondary outcome
Propofol dose
Time frame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection
Results and safety
The study was stopped early (reason given: No more participants enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Results publication: PubMed 12456420Choudhry DK, Brenn BR. Bispectral index monitoring: a comparison between normal children and children with quadriplegic cerebral palsy. Anesth Analg. 2002 Dec;95(6):1582-5, table of contents. doi: 10.1097/00000539-200212000-00020.
- Results publication: PubMed 16428530Malviya S, Voepel-Lewis T, Tait AR. A comparison of observational and objective measures to differentiate depth of sedation in children from birth to 18 years of age. Anesth Analg. 2006 Feb;102(2):389-94. doi: 10.1213/01.ANE.0000184045.01780.73.
- Results publication: PubMed 16324022Saricaoglu F, Celebi N, Celik M, Aypar U. The evaluation of propofol dosage for anesthesia induction in children with cerebral palsy with bispectral index (BIS) monitoring. Paediatr Anaesth. 2005 Dec;15(12):1048-52. doi: 10.1111/j.1460-9592.2005.01658.x.
- Individual participant dataSharing planned: No. no plan to share our data
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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.
Sung Mee Jung, MD,PhD principal investigator
Yeungnam University Hospital
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 Cerebral Palsy, run by Yeungnam University College of Medicine 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 2 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: stopped early, as of the sponsor's last update on 15 Feb 2023. 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?
The study was stopped early (reason given: No more participants enrolled.). Results are not available in the source record.
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?
recovery (time frame: Immediately after discontinuation of propofol infusion used for botulinum toxin injection). 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 NCT04190082, which also lists 3 linked publications.
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 15 Feb 2023.