Obstructive Sleep ApneaEarly Phase 1ROSANCT03958396
Remifentanil in Children With Obstructive Sleep Apnea
A Early Phase 1 study testing Remifentanil Infusion in people with Obstructive Sleep Apnea, run by Washington University School of Medicine.
Trial summary
This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Remifentanil Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Oct 2017
- Phase
- Early Phase 1
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-14 years old
- ASA physical status 1 or 2
- undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea
- 8-14 years old
- ASA physical status 1 or 2
- no known obstructive sleep apnea presenting for any procedure requiring general anesthtic
Who cannot join
- Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
- Control (Non-OSA) Group:
- Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
About this study
Official title: The Pharmacokinetic and Pharmacodynamics Profiles of Remifentanil in Children With Obstructive Sleep Apnea.
This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Remifentanil Infusion
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remifentanil InfusionDrug
15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| OSA Group | Active comparator | a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea Receives: Drug: Remifentanil Infusion |
| Control (non-OSA) Group | Active comparator | a) Children 8-14 years old, b) ASA physical status 1or 2, c) no known obstructive sleep apnea presenting for any procedure requiring general anesthetic Receives: Drug: Remifentanil Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in end-expired carbon dioxide from baseline over time - OSA Group
End-expired carbon dioxide monitoring using bedside monitoring
Measured: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group
End-expired carbon dioxide monitoring using bedside monitoring
Measured: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in respiratory rate from baseline over time - OSA Group
Respiratory monitoring was performed using nasal cannula
Measured: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in respiratory rate from baseline over time - Control (non-OSA) Group
Respiratory monitoring was performed using nasal cannula
Measured: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in pupil diameter from baseline over time - OSA Group
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Measured: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Change in pupil diameter from baseline over time - Control (non-OSA) Group
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Measured: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Remifentanil plasma concentration - OSA Group
3ml blood draw
Measured: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Remifentanil plasma concentration - Contro (non-OSA) Group
3ml blood draw
Measured: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Sep 2015
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group study comparing patients with obstructive sleep apnea undergoing tonsillectomy or tonsillectomy and adenoidectomy to controls with no history of obstructive sleep apnea undergoing general anesthesia for any procedure. The study will be conducted in the patient's preoperative holding area room. Two intravenous catheters will be placed, one for a remifentanil infusion and one for blood draws to measure the blood concentration of remifentanil. Patients will have standard ASA monitors placed with vital signs monitored on a portable monitor, and a remifentanil infusion will be started. Blood draws will be taken at seven time points: zero, one, two, four, six, ten and fifteen minutes. Concomitantly, recordings of end tidal CO2, respiratory rate, and pupil diameter will be made at the seven time points.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anshuman Sharma, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958396
- Sponsor's protocol ID
- 201504056
- Acronym
- ROSA
- Status last verified
- Mar 2020
- First submitted
- 16 May 2019
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
PubMed 21539679Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
PubMed 22926176Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
PubMed 20974339
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetic and Pharmacodynamics Profiles of Remifentanil in Children With Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT03958396
- Acronym / sponsor ID
- ROSA / 201504056
- Conditions
- Obstructive Sleep Apnea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 22 May 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.
This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group study comparing patients with obstructive sleep apnea undergoing tonsillectomy or tonsillectomy and adenoidectomy to controls with no history of obstructive sleep apnea undergoing general anesthesia for any procedure. The study will be conducted in the patient's preoperative holding area room. Two intravenous catheters will be placed, one for a remifentanil infusion and one for blood draws to measure the blood concentration of remifentanil. Patients will have standard ASA monitors placed with vital signs monitored on a portable monitor, and a remifentanil infusion will be started. Blood draws will be taken at seven time points: zero, one, two, four, six, ten and fifteen minutes. Concomitantly, recordings of end tidal CO2, respiratory rate, and pupil diameter will be made at the seven time points.
| Arm | Type | Receives |
|---|---|---|
| OSA Group | Active comparator | Drug: Remifentanil Infusiona) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea |
| Control (non-OSA) Group | Active comparator | Drug: Remifentanil Infusiona) Children 8-14 years old, b) ASA physical status 1or 2, c) no known obstructive sleep apnea presenting for any procedure requiring general anesthetic |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 8-14 years old
- ASA physical status 1 or 2
- undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea
- 8-14 years old
- ASA physical status 1 or 2
Key exclusion criteria (3 listed)
- Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
- Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
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 |
|---|---|---|
| Remifentanil Infusion15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min | Drug | Control (non-OSA) Group, OSA Group |
Primary outcome
Change in end-expired carbon dioxide from baseline over time - OSA Group
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
End-expired carbon dioxide monitoring using bedside monitoring
Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
End-expired carbon dioxide monitoring using bedside monitoring
Change in respiratory rate from baseline over time - OSA Group
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Respiratory monitoring was performed using nasal cannula
Change in respiratory rate from baseline over time - Control (non-OSA) Group
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Respiratory monitoring was performed using nasal cannula
Change in pupil diameter from baseline over time - OSA Group
Time frame: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Change in pupil diameter from baseline over time - Control (non-OSA) Group
Time frame: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Remifentanil plasma concentration - OSA Group
Time frame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
3ml blood draw
Remifentanil plasma concentration - Contro (non-OSA) Group
Time frame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
3ml blood draw
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 Mar 2020.
- Results publication: PubMed 21539679Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
- Results publication: PubMed 22926176Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
- Results publication: PubMed 20974339Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
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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.
Anshuman Sharma, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Remifentanil Infusion in people with Obstructive Sleep Apnea, run by Washington University School of Medicine.
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 6 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: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in end-expired carbon dioxide from baseline over time - OSA Group (time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion). The study lists 8 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 NCT03958396, 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 12 Mar 2020.