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Terminated due to a high number of protocol deviations secondary to non-study approved opioid administration.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Awake extubation/dexmedetomidine | Active Comparator | Awake extubation receiving dexmedetomidine. |
|
| 2. Awake extubation/placebo | Placebo Comparator | Awake extubation receiving placebo (normal saline). |
|
| 3.Deep extubation/dexmedetomidine | Active Comparator | Deep extubation receiving dexmedetomidine. |
|
| 4. Deep extubation/placebo | Placebo Comparator | Deep extubation receiving placebo (normal saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | to arms 2,4. Serves as the placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Respiratory Complications | Number of patients exhibiting any of the following outcomes:
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Makara Cayer, MD | MEEI/ Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MEEI | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. Awake Extubation/Dexmedetomidine | Awake extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 |
| FG001 | 2. Awake Extubation/Placebo | Awake extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. |
| FG002 | 3.Deep Extubation/Dexmedetomidine | Deep extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 |
| FG003 | 4. Deep Extubation/Placebo | Deep extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1. Awake Extubation/Dexmedetomidine | Awake extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 |
| BG001 | 2. Awake Extubation/Placebo | Awake extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Respiratory Complications | Number of patients exhibiting any of the following outcomes:
| Posted | Count of Participants | Participants | 24 hours |
|
24 hours post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. Awake Extubation/Dexmedetomidine | Awake extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-extubation persistent cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Makara Cayer | Massachusetts Eye and Ear | 617-573-3380 | makara_cayer@meei.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2018 | Feb 5, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 29, 2018 | Feb 5, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2020 | Feb 10, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D014069 | Tonsillitis |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Dexmedetomidine | Drug | to arms 1,3 |
|
|
| 24 hours |
| 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. | 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-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. | 24 hours |
| Number of Patients With Unplanned Hospital Admission | Any unplanned hospital admission due to perioperative respiratory adverse events. | 24 hours |
| BG002 | 3.Deep Extubation/Dexmedetomidine | Deep extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 |
| BG003 | 4. Deep Extubation/Placebo | Deep extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 3.Deep Extubation/Dexmedetomidine | Deep extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 |
| OG003 | 4. Deep Extubation/Placebo | Deep extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hrs |
|
|
|
| Secondary | Average Time From End of Surgery to Leaving the Operating Room | Posted | Mean | Standard Deviation | Minutes | 24 hours |
|
|
|
| Secondary | The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) | Posted | Mean | Standard Deviation | Minutes | 24 hrs |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Number of Patients With Unplanned Hospital Admission | Any unplanned hospital admission due to perioperative respiratory adverse events. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 13 |
| 22 |
| EG001 | 2. Awake Extubation/Placebo | Awake extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. | 0 | 21 | 0 | 21 | 15 | 21 |
| EG002 | 3.Deep Extubation/Dexmedetomidine | Deep extubation receiving dexmedetomidine. Dexmedetomidine: to arms 1,3 | 0 | 21 | 0 | 21 | 13 | 21 |
| EG003 | 4. Deep Extubation/Placebo | Deep extubation receiving placebo (normal saline). Normal Saline: to arms 2,4. Serves as the placebo. | 0 | 22 | 0 | 22 | 17 | 22 |
| PACU persistent cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Post-extubation low SaO2 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| PACU low SaO2 | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausea/Vomiting | General disorders | Non-systematic Assessment |
|
| Post-Extubation Stridor | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PACU stridor | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Post-Extubation Croup | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PACU Croup | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Post-Extubation Breath Holding | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PACU Breath Holding | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tonsil Bleed | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|