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

Phase 4

Terminated

Conditions: Adenoiditis
Adenotonsillar Hypertrophy
Obstructive Sleep Apnea
Tonsillitis

Brief 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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
4. Deep extubation/placebo	Normal Saline	Deep extubation receiving placebo (normal saline).
2. Awake extubation/placebo	Normal Saline	Awake extubation receiving placebo (normal saline).
1. Awake extubation/dexmedetomidine	Dexmedetomidine	Awake extubation receiving dexmedetomidine.
3.Deep extubation/dexmedetomidine	Dexmedetomidine	Deep extubation receiving dexmedetomidine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Respiratory Complications	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.

Secondary Outcome Measures

Name	Time	Method
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 With Emergence Agitation	24 hours	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 Participants With Postoperative Nausea and Vomiting (PONV)	24 hrs	Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.
Number of Patients With Unplanned Hospital Admission	24 hours	Any unplanned hospital admission due to perioperative respiratory adverse events.
Number of Participants Needing Follow-up Pain Medication	24 hours	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.