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

Mass Eye and Ear

Status and phase: Terminated; Phase 4

Conditions: Adenotonsillar Hypertrophy; Tonsillitis; Obstructive Sleep Apnea; Adenoiditis

Treatments: Drug: Normal Saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02162433

14-019H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 4 patient groups, including a placebo group

1. Awake extubation/dexmedetomidine

Active Comparator group

Description:

Awake extubation receiving dexmedetomidine.

Treatment:

Drug: Dexmedetomidine

2. Awake extubation/placebo

Placebo Comparator group

Description:

Awake extubation receiving placebo (normal saline).

Treatment:

Drug: Normal Saline

3.Deep extubation/dexmedetomidine

Active Comparator group

Description:

Deep extubation receiving dexmedetomidine.

Treatment:

Drug: Dexmedetomidine

4. Deep extubation/placebo

Placebo Comparator group

Description:

Deep extubation receiving placebo (normal saline).

Treatment:

Drug: Normal Saline