Clinical trial NCT02162433: The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
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?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Adenotonsillar Hypertrophy
Obstructive Sleep Apnea
Tonsillitis
Adenoiditis
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 92
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Respiratory Complications
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants With Emergence Agitation
timeFrame: 24 hours
measure: Number of Participants With Postoperative Nausea and Vomiting (PONV)
timeFrame: 24 hrs
measure: Average Time From End of Surgery to Leaving the Operating Room
timeFrame: 24 hours
measure: The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
timeFrame: 24 hrs
measure: Number of Participants Needing Follow-up Pain Medication
timeFrame: 24 hours
measure: Number of Patients With Unplanned Hospital Admission
timeFrame: 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: MEEI
state: Massachusetts
Study officials:
affiliation: MEEI/ Harvard Medical School
name: Makara Cayer, MD
role: PRINCIPAL_INVESTIGATOR
References: