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

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea; Tonsillitis; Adenotonsillar Hypertrophy; Adenoiditis
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal Saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MEEI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1. Awake extubation/dexmedetomidine; Awake extubation receiving dexmedetomidine.	Drug: Dexmedetomidine; to arms 1,3; Other Names: Precedex
Placebo Comparator: 2. Awake extubation/placebo; Awake extubation receiving placebo (normal saline).	Drug: Normal Saline; to arms 2,4. Serves as the placebo.; Other Names: 0.9% Sodium Chloride Solution
Active Comparator: 3.Deep extubation/dexmedetomidine; Deep extubation receiving dexmedetomidine.	Drug: Dexmedetomidine; to arms 1,3; Other Names: Precedex
Placebo Comparator: 4. Deep extubation/placebo; Deep extubation receiving placebo (normal saline).	Drug: Normal Saline; to arms 2,4. Serves as the placebo.; Other Names: 0.9% Sodium Chloride Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Respiratory Complications	Number of patients exhibiting any of the following outcomes: desaturation to less than 95% for more than 10 seconds;; breath holding;; complete or partial laryngospasm;; bronchospasm;; croup;; number of episodes of persistent cough (three or more consecutive coughs);; negative pressure pulmonary edema;; stridor.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 hrs
Average Time From End of Surgery to Leaving the Operating Room		24 hours
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)		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.	24 hours
Number of Patients With Unplanned Hospital Admission	Any unplanned hospital admission due to perioperative respiratory adverse events.	24 hours

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Makara Cayer, MD, MEEI/ Harvard Medical School

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 23, 2018

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 12, 2014

Study Record Updates

• Last Update Posted (Actual): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 8, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Sleep Apnea Syndromes; Pharyngitis; Sleep Apnea, Obstructive; Hypertrophy; Tonsillitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 14-019H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No