The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Other Indications, Orthopedic, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 3 - 16 |
| Updated: | 3/20/2019 |
| Start Date: | March 2015 |
| End Date: | April 23, 2018 |
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?
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.
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.
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.
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.
We found this trial at
1
site
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