Adenotonsillar HypertrophyPhase 4NCT02162433
The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
A Phase 4 study testing Normal Saline and Dexmedetomidine in people with Adenotonsillar Hypertrophy and Obstructive Sleep Apnea, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Adenotonsillar Hypertrophy, Obstructive Sleep Apnea, Tonsillitis
- What is being tested?
- Normal Saline and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 23 Apr 2018
- Phase
- Phase 4
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
- ASA 1 \& 2
Who cannot join
- Known allergy or hypersensitivity reaction to dexmedetomidine
- Organ dysfunction (renal/hepatic failure or leukemia)
- Cardiac disease (congenital or acquired)
- Airway or thoracic malformation
- Cerebral palsy
- Hypotonia
Show all 11Show fewer
- Need for premedication
- Current/recent upper respiratory infection (within four weeks prior to the surgery)
- Asthma
- Allergy or intolerance to clonidine
- Non-English speaking parents/patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Dexmedetomidine Decrease the Incidence of Untoward Airway Events After Deep or Awake Extubation in Patients Undergoing Adenotonsillectomy With or Without Myringotomy and Tube Placement?
The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.
Read the detailed description
We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.
- Being tested
- Normal Saline, Dexmedetomidine
- Medical subject headings
- Sleep Apnea, Obstructive, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called 0.9% Sodium Chloride Solution
to arms 2,4. Serves as the placebo.
DexmedetomidineDrug
Also called Precedex
to arms 1,3
| Study group | Role | What they receive |
|---|---|---|
| 1. Awake extubation/dexmedetomidine | Active comparator | Awake extubation receiving dexmedetomidine. Receives: Drug: Dexmedetomidine |
| 2. Awake extubation/placebo | Placebo comparator | Awake extubation receiving placebo (normal saline). Receives: Drug: Normal Saline |
| 3.Deep extubation/dexmedetomidine | Active comparator | Deep extubation receiving dexmedetomidine. Receives: Drug: Dexmedetomidine |
| 4. Deep extubation/placebo | Placebo comparator | Deep extubation receiving placebo (normal saline). Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Respiratory Complications
Number of patients exhibiting any of the following outcomes:
- desaturation to less than 95% for more than 10 seconds;
- breath holding;
- complete or partial laryngospasm;
- bronchospasm;
- croup;
- number of episodes of persistent cough (three or more consecutive coughs);
- negative pressure pulmonary edema;
- stridor.
Measured: 24 hours
Secondary outcomes (6)
Number of Participants With Emergence Agitation
Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of >10.
Emergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state.
Measured: 24 hours
Number of Participants With Postoperative Nausea and Vomiting (PONV)
Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.
Measured: 24 hrs
Average Time From End of Surgery to Leaving the Operating Room
Measured: 24 hours
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
Measured: 24 hrs
Number of Participants Needing Follow-up Pain Medication
24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery.
Measured: 24 hours
Number of Patients With Unplanned Hospital Admission
Any unplanned hospital admission due to perioperative respiratory adverse events.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2018
- Study completion23 Apr 2018
Why it stopped: Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.
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 Adenotonsillar HypertrophyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makara Cayer, Massachusetts Eye and Ear Infirmary
- Investigators
- Makara Cayer, MD, Principal investigator, MEEI/ Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162433
- Sponsor's protocol ID
- 14-019H
- Status last verified
- Apr 2020
- First submitted
- 10 Jun 2014
- Last updated
- 9 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dexmedetomidine Decrease the Incidence of Untoward Airway Events After Deep or Awake Extubation in Patients Undergoing Adenotonsillectomy With or Without Myringotomy and Tube Placement?
- ClinicalTrials.gov ID
- NCT02162433
- Acronym / sponsor ID
- 14-019H
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Posted 9 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.
Detailed description
We propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to Massachusetts Eye and Ear Infirmary (MEEI) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. A Clinical Pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. The anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the Clinical Pharmacy specialist. Multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Awake extubation/dexmedetomidine | Active comparator | Drug: DexmedetomidineAwake extubation receiving dexmedetomidine. |
| 2. Awake extubation/placebo | Placebo comparator | Drug: Normal SalineAwake extubation receiving placebo (normal saline). |
| 3.Deep extubation/dexmedetomidine | Active comparator | Drug: DexmedetomidineDeep extubation receiving dexmedetomidine. |
| 4. Deep extubation/placebo | Placebo comparator | Drug: Normal SalineDeep extubation receiving placebo (normal saline). |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
- ASA 1 \& 2
Key exclusion criteria (11 listed)
- Known allergy or hypersensitivity reaction to dexmedetomidine
- Organ dysfunction (renal/hepatic failure or leukemia)
- Cardiac disease (congenital or acquired)
- Airway or thoracic malformation
- Cerebral palsy
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 |
|---|---|---|
| Normal SalineAlso: 0.9% Sodium Chloride Solutionto arms 2,4. Serves as the placebo. | Drug | 2. Awake extubation/placebo, 4. Deep extubation/placebo |
| DexmedetomidineAlso: Precedexto arms 1,3 | Drug | 1. Awake extubation/dexmedetomidine, 3.Deep extubation/dexmedetomidine |
Primary outcome
Number of Participants With Respiratory Complications
Time frame: 24 hours
Number of patients exhibiting any of the following outcomes: 1. desaturation to less than 95% for more than 10 seconds; 2. breath holding; 3. complete or partial laryngospasm; 4. bronchospasm; 5. croup; 6. number of episodes of persistent cough (three or more consecutive coughs); 7. negative pressure pulmonary edema; 8. stridor.
6 secondary outcomes
Number of Participants With Emergence Agitation
Time frame: 24 hours
Number of Participants With Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hrs
Average Time From End of Surgery to Leaving the Operating Room
Time frame: 24 hours
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
Time frame: 24 hrs
Number of Participants Needing Follow-up Pain Medication
Time frame: 24 hours
Number of Patients With Unplanned Hospital Admission
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Adenotonsillar Hypertrophy
RecruitingObservational study
Serum and Salivary Leptin Levels in Children With Adenoid/Adenotonsillar Hypertrophy
Adenoid Hypertrophy, Adenotonsillar Hypertrophy
Active, not recruitingObservational study
Heart Rate Variability and Early Cytokine Profile in Pediatric Adenotonsillectomy
Heart Rate Monitoring, Vagal Bradycardia
Recruiting
Conox-Guided Anesthesia in Pediatric Adenotonsillectomy
Adenotonsillar Hypertrophy, Postoperative Pain
Recruiting
Teleconsultation vs Face-to-Face Evaluation for Perioperative Respiratory Events in Pediatric Adenotonsillectomy
Adenotonsillar Hypertrophy
Not yet recruitingPhase 4
Remiazolam vs Propofol Total Intravenous Anesthesia on Postoperative Neurodevelopment After General Anesthesia in Children
Adenotonsillar Hypertrophy
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.
Makara Cayer, MD principal investigator
MEEI/ Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Normal Saline and Dexmedetomidine in people with Adenotonsillar Hypertrophy and Obstructive Sleep Apnea, run by Massachusetts Eye and Ear Infirmary 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 2 inclusion and 11 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 9 Apr 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 Apr 2020). 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 Participants With Respiratory Complications (time frame: 24 hours). 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 9 Apr 2020.