Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162433
Recruitment Status : Terminated (Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.)
First Posted : June 12, 2014
Results First Posted : April 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Makara Cayer, Massachusetts Eye and Ear Infirmary

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adenotonsillar Hypertrophy Obstructive Sleep Apnea Tonsillitis Adenoiditis Drug: Normal Saline Drug: Dexmedetomidine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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?
Study Start Date : March 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1. Awake extubation/dexmedetomidine
Awake extubation receiving dexmedetomidine.
Drug: Dexmedetomidine
to arms 1,3
Other Name: 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 Name: 0.9% Sodium Chloride Solution

Active Comparator: 3.Deep extubation/dexmedetomidine
Deep extubation receiving dexmedetomidine.
Drug: Dexmedetomidine
to arms 1,3
Other Name: 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 Name: 0.9% Sodium Chloride Solution




Primary Outcome Measures :
  1. Number of Participants With Respiratory Complications [ Time Frame: 24 hours ]

    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.


Secondary Outcome Measures :
  1. Number of Participants With Emergence Agitation [ Time Frame: 24 hours ]

    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.


  2. Number of Participants With Postoperative Nausea and Vomiting (PONV) [ Time Frame: 24 hrs ]
    Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.

  3. Average Time From End of Surgery to Leaving the Operating Room [ Time Frame: 24 hours ]
  4. The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) [ Time Frame: 24 hrs ]
  5. Number of Participants Needing Follow-up Pain Medication [ Time Frame: 24 hours ]
    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.

  6. Number of Patients With Unplanned Hospital Admission [ Time Frame: 24 hours ]
    Any unplanned hospital admission due to perioperative respiratory adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162433


Locations
Layout table for location information
United States, Massachusetts
MEEI
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Layout table for investigator information
Principal Investigator: Makara Cayer, MD MEEI/ Harvard Medical School
  Study Documents (Full-Text)

Documents provided by Makara Cayer, Massachusetts Eye and Ear Infirmary:
Informed Consent Form  [PDF] January 29, 2018
Study Protocol  [PDF] January 29, 2018
Statistical Analysis Plan  [PDF] February 7, 2020

Layout table for additonal information
Responsible Party: Makara Cayer, Prinicpal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02162433    
Other Study ID Numbers: 14-019H
First Posted: June 12, 2014    Key Record Dates
Results First Posted: April 9, 2020
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tonsillitis
Sleep Apnea, Obstructive
Hypertrophy
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents