Adolescent Idiopathic ScoliosisAISNCT02481570
Anesthetic Optimization in Scoliosis Surgery
A study testing pharmacokinetic simulation in people with Adolescent Idiopathic Scoliosis and Respiratory Depression, run by University of Florida at 1 site in United States.
Trial summary
The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Respiratory Depression, Postoperative Pain
- What is being tested?
- pharmacokinetic simulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 15 Aug 2017
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class 1-2
- At least 10 years of age and not older than 18 years of age
- Diagnosis of idiopathic adolescent scoliosis
Who cannot join
- Currently pregnant
- Currently breastfeeding
- Currently being treated with opiates
- Currently being treated with alpha2 agonists
- Currently being treated with anticonvulsants
- Currently being treated with antidepressants
- History of significant restrictive lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.
Read the detailed description
As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.
- Being tested
- pharmacokinetic simulation
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis surgery, Pharmacokinetic simulation
- Medical subject headings
- Respiratory Insufficiency, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacokinetic simulationOther
The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia optimization | Experimental | Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA) Receives: Other: pharmacokinetic simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-Item Pain Intensity Measure
0 - 10 (0=no pain; 10 = pain as bad as can be)
Measured: 24 hours
Respiratory depression
Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.
Measured: 24 hours
Secondary outcomes (1)
Utility of pharmacokinetic simulation
The number of modifications to the anesthetic dosing
Measured: 4 - 8 hours (Intraoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startNov 2015
- Primary completion21 Nov 2016
- Study completion15 Aug 2017
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 Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Seubert, MD PhD DABNM, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481570
- Sponsor's protocol ID
- IRB201500120
- Acronym
- AIS
- Status last verified
- Aug 2019
- First submitted
- 23 Jun 2015
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tams C, Dooley FC, Sangari TS, Gonzalez-Rodriguez SN, Stoker RE, Phillips SA, Koenig M, Wishin JM, Molinari SC, Blakemore LC, Seubert CN. Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study. Global Spine J. 2020 Oct;10(7):837-843. doi: 10.1177/2192568219878135. Epub 2019 Sep 26.
PubMed 32905725
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
- ClinicalTrials.gov ID
- NCT02481570
- Acronym / sponsor ID
- AIS / IRB201500120
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis surgery, Pharmacokinetic simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 25 Jun 2015 (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 standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.
Detailed description
As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia optimization | Experimental | Other: pharmacokinetic simulationInformation from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) class 1-2
- At least 10 years of age and not older than 18 years of age
- Diagnosis of idiopathic adolescent scoliosis
Key exclusion criteria (7 listed)
- Currently pregnant
- Currently breastfeeding
- Currently being treated with opiates
- Currently being treated with alpha2 agonists
- Currently being treated with anticonvulsants
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 |
|---|---|---|
| pharmacokinetic simulationThe aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence. | Other | Anesthesia optimization |
Primary outcome
4-Item Pain Intensity Measure
Time frame: 24 hours
0 - 10 (0=no pain; 10 = pain as bad as can be)
Respiratory depression
Time frame: 24 hours
Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.
1 secondary outcome
Utility of pharmacokinetic simulation
Time frame: 4 - 8 hours (Intraoperative period)
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 12 Aug 2019.
- Derived from this study: PubMed 32905725Tams C, Dooley FC, Sangari TS, Gonzalez-Rodriguez SN, Stoker RE, Phillips SA, Koenig M, Wishin JM, Molinari SC, Blakemore LC, Seubert CN. Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study. Global Spine J. 2020 Oct;10(7):837-843. doi: 10.1177/2192568219878135. Epub 2019 Sep 26.
- Individual participant dataSharing planned: No
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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.
Christoph Seubert, MD PhD DABNM principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacokinetic simulation in people with Adolescent Idiopathic Scoliosis and Respiratory Depression, run by University of Florida at 1 site in United States.
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 7 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 12 Aug 2019. 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 United States. 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 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?
4-Item Pain Intensity Measure (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT02481570, 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 12 Aug 2019.