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TerminatedNCT02162433Updated Apr 9, 2020Results posted

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

A Phase 4 interventional study of Normal Saline and Dexmedetomidine in Adenotonsillar Hypertrophy, Obstructive Sleep Apnea and Tonsillitis, sponsored by Massachusetts Eye and Ear Infirmary. Terminated at 1 site in United States. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-04-09.

Sponsored by Massachusetts Eye and Ear Infirmary · Phase 4, Interventional, and Prevention

Why this study was terminated
Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.
Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
3 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adenotonsillar Hypertrophy
  • Obstructive Sleep Apnea
  • Tonsillitis
  • Adenoiditis
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's enrollment of 92 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Browse Massachusetts Eye and Ear Infirmary studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty
  • ASA 1 \& 2

Exclusion criteria

Exclusion Criteria:

  • Known allergy or 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Active comparator
    1. Awake extubation/dexmedetomidine

    Awake extubation receiving dexmedetomidine.

    Drug: Dexmedetomidine

  • Placebo comparator
    2. Awake extubation/placebo

    Awake extubation receiving placebo (normal saline).

    Drug: Normal Saline

  • Active comparator
    3.Deep extubation/dexmedetomidine

    Deep extubation receiving dexmedetomidine.

    Drug: Dexmedetomidine

  • Placebo comparator
    4. Deep extubation/placebo

    Deep extubation receiving placebo (normal saline).

    Drug: Normal Saline

Interventions

  • DrugNormal Saline

    to arms 2,4. Serves as the placebo.

    Also known as: 0.9% Sodium Chloride Solution

  • DrugDexmedetomidine

    to arms 1,3

    Also known as: Precedex

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  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

    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

  6. Number of Patients With Unplanned Hospital Admission

    Any unplanned hospital admission due to perioperative respiratory adverse events.

    Time frame: 24 hours

07

Results

Posted Apr 9, 2020

Participant flow

Participant flow — Overall Study
Milestone1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Started23232323
Completed22212122
Not completed1221

Outcome measures

PrimaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Respiratory Complications
Participants1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Number of Participants With Respiratory Complications13151317
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Emergence Agitation
Participants1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Number of Participants With Emergence Agitation713913
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Postoperative Nausea and Vomiting (PONV)
Participants1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Number of Participants With Postoperative Nausea and Vomiting (PONV)5663
SecondaryAverage Time From End of Surgery to Leaving the Operating Room
Time frame:
24 hours
Reported as:
Mean · Minutes
Average Time From End of Surgery to Leaving the Operating Room
Minutes1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Average Time From End of Surgery to Leaving the Operating Room19.15 ± 5.518.05 ± 7.4310.29 ± 3.7311.77 ± 5.6
SecondaryThe Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
Time frame:
24 hrs
Reported as:
Mean · Minutes
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
Minutes1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)345.06 ± 91.23320.19 ± 69.07341.53 ± 73.85328.05 ± 93.97
SecondaryNumber 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.

Time frame:
24 hours
Reported as:
Count of participants · Participants
Number of Participants Needing Follow-up Pain Medication
Participants1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Number of Participants Needing Follow-up Pain Medication18172018
SecondaryNumber of Patients With Unplanned Hospital Admission

Any unplanned hospital admission due to perioperative respiratory adverse events.

Time frame:
24 hours
Reported as:
Count of participants · Participants
Number of Patients With Unplanned Hospital Admission
Participants1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
Number of Patients With Unplanned Hospital Admission0200

Adverse events

Collected over 24 hours post-op. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1. Awake Extubation/Dexmedetomidine0/22 (0%)0/22 (0%)13/22 (59.1%)
2. Awake Extubation/Placebo0/21 (0%)0/21 (0%)15/21 (71.4%)
3.Deep Extubation/Dexmedetomidine0/21 (0%)0/21 (0%)13/21 (61.9%)
4. Deep Extubation/Placebo0/22 (0%)0/22 (0%)17/22 (77.3%)
Most frequent other events
Showing 10 of 13
Most frequent other events
Event1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/Placebo
PACU persistent coughRespiratory, thoracic and mediastinal disorders3/225/218/219/22
PACU low SaO2Blood and lymphatic system disorders6/226/218/217/22
Post-extubation persistent coughRespiratory, thoracic and mediastinal disorders5/226/211/214/22
Post-extubation low SaO2Blood and lymphatic system disorders6/224/210/211/22
PACU Breath HoldingRespiratory, thoracic and mediastinal disorders0/221/213/211/22
Post-Extubation StridorRespiratory, thoracic and mediastinal disorders0/220/211/213/22
PACU CroupRespiratory, thoracic and mediastinal disorders0/222/211/213/22
PACU stridorRespiratory, thoracic and mediastinal disorders0/220/212/212/22
Nausea/VomitingGeneral disorders1/221/210/212/22
Post-Extubation CroupRespiratory, thoracic and mediastinal disorders1/221/210/210/22

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/PlaceboTotal
<=18 years2323232392
Between 18 and 65 years00000
>=65 years00000
Age, Continuous
Age, Continuous(years)1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/PlaceboTotal
Mean6.64 ± 3.216.1 ± 2.896.52 ± 2.796.64 ± 2.86.48 ± 2.94
Sex: Female, Male
Sex: Female, Male(Participants)1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/PlaceboTotal
Female9912939
Male1414111453
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/PlaceboTotal
Count of participants————0
Region of Enrollment
Region of Enrollment(participants)1. Awake Extubation/Dexmedetomidine2. Awake Extubation/Placebo3.Deep Extubation/Dexmedetomidine4. Deep Extubation/PlaceboTotal
United States2323232392
08

Study locations

1 site
  • MEEI
    Boston, Massachusetts 02114, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02162433
Lead sponsor
Massachusetts Eye and Ear Infirmary
Responsible party
Makara Cayer (Prinicpal Investigator, Massachusetts Eye and Ear Infirmary) — Principal investigator
First posted
Jun 12, 2014
Start date
Mar 2015
Primary completion
Apr 2018
Completion
Apr 23, 2018
Results posted
Apr 9, 2020
Last update
Apr 9, 2020

Study contacts

Makara Cayer, MD
principal investigator · MEEI/ Harvard Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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