The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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?

Conditions
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Tonsillitis, Adenotonsillar Hypertrophy, Obstructive Sleep Apnea, Adenoiditis

Intervention / Treatment
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* Drug: Normal Saline
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty ASA 1 & 2 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Awake extubation/dexmedetomidine<br>Awake extubation receiving dexmedetomidine. | Drug: Dexmedetomidine<br>* to arms 1,3<br>* Other names: Precedex;|
| Placebo Comparator: 2. Awake extubation/placebo<br>Awake extubation receiving placebo (normal saline). | Drug: Normal Saline<br>* to arms 2,4. Serves as the placebo.<br>* Other names: 0.9% Sodium Chloride Solution;|
| Active Comparator: 3.Deep extubation/dexmedetomidine<br>Deep extubation receiving dexmedetomidine. | Drug: Dexmedetomidine<br>* to arms 1,3<br>* Other names: Precedex;|
| Placebo Comparator: 4. Deep extubation/placebo<br>Deep extubation receiving placebo (normal saline). | Drug: Normal Saline<br>* to arms 2,4. Serves as the placebo.<br>* Other names: 0.9% Sodium Chloride Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 hrs | 
| Average Time From End of Surgery to Leaving the Operating Room |  | 24 hours | 
| The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) |  | 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. | 24 hours | 
| Number of Patients With Unplanned Hospital Admission | Any unplanned hospital admission due to perioperative respiratory adverse events. | 24 hours |