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

Phase 4TerminatedNCT02162433

Massachusetts Eye and Ear Infirmary92 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Adenotonsillar Hypertrophy Obstructive Sleep Apnea Tonsillitis Adenoiditis

Interventions

Normal SalineDRUG

to arms 2,4. Serves as the placebo.

DexmedetomidineDRUG

to arms 1,3

Eligibility

Sex: ALLMin age: 3 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

MEEI

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants With Respiratory Complications

Number of patients exhibiting any of the following outcomes: 1. desaturation to less than 95% for more than 10 seconds; 2. breath holding; 3. complete or partial laryngospasm; 4. bronchospasm; 5. croup; 6. number of episodes of persistent cough (three or more consecutive coughs); 7. negative pressure pulmonary edema; 8. stridor.

Time frame: 24 hours

Secondary Outcomes

Number of Participants With Emergence Agitation

Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of \>10. Emergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state.

Time frame: 24 hours

Number of Participants With Postoperative Nausea and Vomiting (PONV)

Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.

Time frame: 24 hrs

Average Time From End of Surgery to Leaving the Operating Room

Time frame: 24 hours

The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)

Time frame: 24 hrs

Number of Participants Needing Follow-up Pain Medication

24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.