TerminatedPhase 4

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

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

United States92 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range3 Years – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Respiratory Complications

Timeframe: 24 hours

Trial details

NCT IDNCT02162433

SponsorMassachusetts Eye and Ear Infirmary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

Results submitted2020-02-12

View on ClinicalTrials.gov More Adenotonsillar Hypertrophy trials