The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
Primary Purpose
Adenotonsillar Hypertrophy, Obstructive Sleep Apnea, Tonsillitis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Normal Saline
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Adenotonsillar Hypertrophy
Eligibility 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.
Sites / Locations
- MEEI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
1. Awake extubation/dexmedetomidine
2. Awake extubation/placebo
3.Deep extubation/dexmedetomidine
4. Deep extubation/placebo
Arm Description
Awake extubation receiving dexmedetomidine.
Awake extubation receiving placebo (normal saline).
Deep extubation receiving dexmedetomidine.
Deep extubation receiving placebo (normal saline).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Average Time From End of Surgery to Leaving the Operating Room
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
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.
Number of Patients With Unplanned Hospital Admission
Any unplanned hospital admission due to perioperative respiratory adverse events.
Full Information
NCT ID
NCT02162433
First Posted
June 10, 2014
Last Updated
April 8, 2020
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT02162433
Brief Title
The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenotonsillar Hypertrophy, Obstructive Sleep Apnea, Tonsillitis, Adenoiditis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Awake extubation/dexmedetomidine
Arm Type
Active Comparator
Arm Description
Awake extubation receiving dexmedetomidine.
Arm Title
2. Awake extubation/placebo
Arm Type
Placebo Comparator
Arm Description
Awake extubation receiving placebo (normal saline).
Arm Title
3.Deep extubation/dexmedetomidine
Arm Type
Active Comparator
Arm Description
Deep extubation receiving dexmedetomidine.
Arm Title
4. Deep extubation/placebo
Arm Type
Placebo Comparator
Arm Description
Deep extubation receiving placebo (normal saline).
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
0.9% Sodium Chloride Solution
Intervention Description
to arms 2,4. Serves as the placebo.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
to arms 1,3
Primary Outcome Measure Information:
Title
Number of Participants With Respiratory Complications
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of Participants With Emergence Agitation
Description
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
Title
Number of Participants With Postoperative Nausea and Vomiting (PONV)
Description
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
Title
Average Time From End of Surgery to Leaving the Operating Room
Time Frame
24 hours
Title
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
Time Frame
24 hrs
Title
Number of Participants Needing Follow-up Pain Medication
Description
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.
Time Frame
24 hours
Title
Number of Patients With Unplanned Hospital Admission
Description
Any unplanned hospital admission due to perioperative respiratory adverse events.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makara Cayer, MD
Organizational Affiliation
MEEI/ Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
MEEI
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation
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