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

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?

Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.

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.

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.

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.

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.

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-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.

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.