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Trial record 17 of 18 for:    Recruiting, Not yet recruiting, Available Studies | "Tonsillitis"

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

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ClinicalTrials.gov Identifier: NCT02162433
Recruitment Status : Recruiting
First Posted : June 12, 2014
Last Update Posted : March 8, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 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
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

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. Respiratory Complications [ Time Frame: 2 years ]
    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. Anesthesia/Surgery Side Effects [ Time Frame: 2 years ]
    1. Incidence of emergence agitation;
    2. Incidence of postoperative nausea and vomiting (PONV);

  2. Time Parameters [ Time Frame: 2 years ]
    1. Length of time from end of surgery to leaving the operating room;
    2. The length of stay from admission to the PACU to discharge home;

  3. 24 hour Postoperative follow-up Pain medication Requirements [ Time Frame: 2 years ]
    5) 24-hour postoperative pain control requirements assessed by the questionnaire given to parents at the time of discharge;

  4. Unplanned hospital admission [ Time Frame: 2 years ]
    6) Any unplanned hospital admission due to perioperative respiratory adverse events.



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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


Contacts
Contact: Alex Ciaramella, BS 6175237900 ext 34016 Alex_Ciaramella@meei.harvard.edu

Locations
United States, Massachusetts
MEEI Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alex Ciaramella, BS    617-523-7900 ext 34016    Alex_Ciaramella@meei.Harvard.edu   
Principal Investigator: Makara Cayer, M.D.         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Makara Cayer, MD MEEI/ Harvard Medical School

Responsible Party: Makara Cayer, Prinicpal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02162433     History of Changes
Other Study ID Numbers: 14-019H
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant 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