Sleep Apnea, ObstructivePhase 2OSANCT00273754
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
A Phase 2 study testing Caffeine in people with Sleep Apnea, Obstructive and Tonsillectomy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. Read more about this study
- Who is it for?
- Ages 30 months to 18 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Tonsillectomy, Adenoidectomy
- What is being tested?
- Caffeine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between 2.5-18 years old
- Diagnosed with obstructive sleep apnea
- Undergoing elective tonsillectomy and adenoidectomy
Who cannot join
- Age below 2.5 or above 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas, Health Science Center at Houston, Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
Official title: A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy.
This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).
Read the detailed description
Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.
Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.
The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T \& A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.
- Being tested
- Caffeine, Placebo
- Keywords
- Obstructive Sleep Apnea (OSA), Tonsillectomy and Adenoidectomy (T&A), Postoperative Complications, Recovery
- Medical subject headings
- Sleep Apnea, Obstructive, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.
PlaceboDrug
Also called Saline
Children in group two will receive an amount of normal saline equal to Caffeine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline Receives: Drug: Placebo |
| Caffeine | Active comparator | Caffeine benzoate Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.
Measured: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Secondary outcomes (5)
Occurence of Post Extubatory Respiratory Adverse Events.
The overall occurance of adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the OR and in the PACU was noted.
Measured: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Extubation Time.
Time from end of anesthesia until extubation.
Measured: Duration from anesthesia end until extubation time.
Awakening Time
A child with a Steward Recovery Scale score of 6 is defined as awake, coughing/crying, and has purposeful movements.
Measured: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.
Post Anesthesia Care Unit (PACU) Duration
Measured: Time spent in PACU following surgical procedure prior to discharge home or hospital admission.
Hospital Discharge Time
Children were discharged from the hospital when they reached the hospital discharge criteria: they were awake, had stable vital signs, were breathing adequately, had O2 saturation >95% while breathing room air, were able to swallow fluids, had no or minimal pain, and were able to ambulate without excessive nausea, vomiting, or dizziness.
Measured: Total time from end anesthesia to discharge home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startSep 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samia Khalil, The University of Texas Health Science Center, Houston
- Investigators
- Samia N. Khalil, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273754
- Sponsor's protocol ID
- HSC-MS-03-108
- Acronym
- OSA
- Status last verified
- May 2016
- First submitted
- 4 Jan 2006
- Last updated
- 16 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate if Caffeine Helps Children With Obstructive Sleep Apnea Recover Faster From Anesthesia, and With Less Complications After General Anesthesia for Tonsillectomy and Adenoidectomy.
- ClinicalTrials.gov ID
- NCT00273754
- Acronym / sponsor ID
- OSA / HSC-MS-03-108
- Keywords
- Obstructive Sleep Apnea (OSA), Tonsillectomy and Adenoidectomy (T&A), Postoperative Complications, Recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Posted 10 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).
Detailed description
Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.
Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.
The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T \& A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline |
| Caffeine | Active comparator | Drug: CaffeineCaffeine benzoate |
Who may qualify
- Ages
- 30 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children between 2.5-18 years old
- Diagnosed with obstructive sleep apnea
- Undergoing elective tonsillectomy and adenoidectomy
Key exclusion criteria (1 listed)
- Age below 2.5 or above 18 years
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 |
|---|---|---|
| CaffeineChildren in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. | Drug | Caffeine |
| PlaceboAlso: SalineChildren in group two will receive an amount of normal saline equal to Caffeine | Drug | Placebo |
Primary outcome
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo.
Time frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
The number of children having adverse post-extubation respiratory events, including laryngospasm, upper airway obstruction, apnea, desaturation (defined as decrease in oxygen saturation <95% while breathing oxygen via mask for any length of time) and need for reintubation, both in the Operating Room and in the PACU was recorded.
5 secondary outcomes
Occurence of Post Extubatory Respiratory Adverse Events.
Time frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.
Extubation Time.
Time frame: Duration from anesthesia end until extubation time.
Awakening Time
Time frame: Awakening time from end of anesthesia until the child reached a score of 6 on the Steward recovery score.
Post Anesthesia Care Unit (PACU) Duration
Time frame: Time spent in PACU following surgical procedure prior to discharge home or hospital admission.
Hospital Discharge Time
Time frame: Total time from end anesthesia to discharge home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samia N. Khalil, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caffeine in people with Sleep Apnea, Obstructive and Tonsillectomy, run by The University of Texas Health Science Center, Houston 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 1 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 16 Jun 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Children Who Developed Postextubation Adverse Respiratory Events Compared to Placebo. (time frame: Time post extubation in OR and PACU until the patient was discharged from the PACU to go home or to a hospital room.). 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 16 Jun 2016.