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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-04-23

Brief Summary

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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.

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Detailed Description

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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

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Adenotonsillar Hypertrophy Obstructive Sleep Apnea Tonsillitis Adenoiditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1. Awake extubation/dexmedetomidine

Awake extubation receiving dexmedetomidine.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

to arms 1,3

2. Awake extubation/placebo

Awake extubation receiving placebo (normal saline).

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

to arms 2,4. Serves as the placebo.

3.Deep extubation/dexmedetomidine

Deep extubation receiving dexmedetomidine.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

to arms 1,3

4. Deep extubation/placebo

Deep extubation receiving placebo (normal saline).

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

to arms 2,4. Serves as the placebo.

Interventions

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Normal Saline

to arms 2,4. Serves as the placebo.

Intervention Type DRUG

Dexmedetomidine

to arms 1,3

Intervention Type DRUG

Other Intervention Names

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0.9% Sodium Chloride Solution Precedex

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No