NCT02162433

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?

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenotonsillar Hypertrophy
• Obstructive Sleep Apnea
• Tonsillitis
• Adenoiditis

Interventions

Type	Name	Description
DRUG	Normal Saline	to arms 2,4. Serves as the placebo.
DRUG	Dexmedetomidine	to arms 1,3

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-04-01
• Completion: 2018-04-23
• First posted: 2014-06-12
• Last updated: 2020-04-09
• Results posted: 2020-04-09

Locations

1 site across 1 country: United States