NCT02162433

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 9, 2020

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

3.1 years

First QC Date

June 10, 2014

Results QC Date

February 12, 2020

Last Update Submit

April 8, 2020

Conditions

Adenotonsillar HypertrophyObstructive Sleep ApneaTonsillitisAdenoiditis

Outcome Measures

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.

    24 hours

Secondary Outcomes (6)

  • Number of Participants With Emergence Agitation

    24 hours

  • Number of Participants With Postoperative Nausea and Vomiting (PONV)

    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 hours

  • +1 more secondary outcomes

Study Arms (4)

1. Awake extubation/dexmedetomidine

ACTIVE COMPARATOR

Awake extubation receiving dexmedetomidine.

Drug: Dexmedetomidine

2. Awake extubation/placebo

PLACEBO COMPARATOR

Awake extubation receiving placebo (normal saline).

Drug: Normal Saline

3.Deep extubation/dexmedetomidine

ACTIVE COMPARATOR

Deep extubation receiving dexmedetomidine.

Drug: Dexmedetomidine

4. Deep extubation/placebo

PLACEBO COMPARATOR

Deep extubation receiving placebo (normal saline).

Drug: Normal Saline

Interventions

Normal SalineDRUG

to arms 2,4. Serves as the placebo.

Also known as: 0.9% Sodium Chloride Solution
2. Awake extubation/placebo4. Deep extubation/placebo
DexmedetomidineDRUG

to arms 1,3

Also known as: Precedex
1. Awake extubation/dexmedetomidine3.Deep extubation/dexmedetomidine

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MEEI

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveTonsillitis

Interventions

Saline SolutionSodium ChlorideDexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Makara Cayer
Organization
Massachusetts Eye and Ear
makara_cayer@meei.harvard.edu
617-573-3380

Study Officials

  • Makara Cayer, MD

    MEEI/ Harvard Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

March 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 23, 2018

Last Updated

April 9, 2020

Results First Posted

April 9, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)