Adenoiditis, Adenotonsillar Hypertrophy, Obstructive Sleep Apnea, Tonsillitis
Conditions
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.
Interventions
DRUGNormal Saline
to arms 2,4. Serves as the placebo.
DRUGDexmedetomidine
to arms 1,3
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Respiratory Complications | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Nausea and Vomiting (PONV) | 24 hrs | 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 | 24 hours | — |
| Number of Participants With Emergence Agitation | 24 hours | 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 Needing Follow-up Pain Medication | 24 hours | 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 | 24 hours | Any unplanned hospital admission due to perioperative respiratory adverse events. |
| The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) | 24 hrs | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1. Awake Extubation/Dexmedetomidine Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3 | 23 |
| 2. Awake Extubation/Placebo Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo. | 23 |
| 3.Deep Extubation/Dexmedetomidine Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3 | 23 |
| 4. Deep Extubation/Placebo Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo. | 23 |
| Total | 92 |
Baseline characteristics
| Characteristic | 2. Awake Extubation/Placebo | 3.Deep Extubation/Dexmedetomidine | 4. Deep Extubation/Placebo | 1. Awake Extubation/Dexmedetomidine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 23 Participants | 23 Participants | 23 Participants | 92 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.1 years STANDARD_DEVIATION 2.89 | 6.52 years STANDARD_DEVIATION 2.79 | 6.64 years STANDARD_DEVIATION 2.8 | 6.64 years STANDARD_DEVIATION 3.21 | 6.48 years STANDARD_DEVIATION 2.94 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 23 participants | 23 participants | 23 participants | 23 participants | 92 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 9 Participants | 9 Participants | 39 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 14 Participants | 14 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 13 / 22 | 15 / 21 | 13 / 21 | 17 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 | 0 / 21 | 0 / 22 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | Number of Participants With Respiratory Complications | 13 Participants |
| 2. Awake Extubation/Placebo | Number of Participants With Respiratory Complications | 15 Participants |
| 3.Deep Extubation/Dexmedetomidine | Number of Participants With Respiratory Complications | 13 Participants |
| 4. Deep Extubation/Placebo | Number of Participants With Respiratory Complications | 17 Participants |
Secondary
Average Time From End of Surgery to Leaving the Operating Room
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | Average Time From End of Surgery to Leaving the Operating Room | 19.15 Minutes | Standard Deviation 5.5 |
| 2. Awake Extubation/Placebo | Average Time From End of Surgery to Leaving the Operating Room | 18.05 Minutes | Standard Deviation 7.43 |
| 3.Deep Extubation/Dexmedetomidine | Average Time From End of Surgery to Leaving the Operating Room | 10.29 Minutes | Standard Deviation 3.73 |
| 4. Deep Extubation/Placebo | Average Time From End of Surgery to Leaving the Operating Room | 11.77 Minutes | Standard Deviation 5.6 |
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | Number of Participants Needing Follow-up Pain Medication | 18 Participants |
| 2. Awake Extubation/Placebo | Number of Participants Needing Follow-up Pain Medication | 17 Participants |
| 3.Deep Extubation/Dexmedetomidine | Number of Participants Needing Follow-up Pain Medication | 20 Participants |
| 4. Deep Extubation/Placebo | Number of Participants Needing Follow-up Pain Medication | 18 Participants |
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | Number of Participants With Emergence Agitation | 7 Participants |
| 2. Awake Extubation/Placebo | Number of Participants With Emergence Agitation | 13 Participants |
| 3.Deep Extubation/Dexmedetomidine | Number of Participants With Emergence Agitation | 9 Participants |
| 4. Deep Extubation/Placebo | Number of Participants With Emergence Agitation | 13 Participants |
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.
Time frame: 24 hrs
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | Number of Participants With Postoperative Nausea and Vomiting (PONV) | 5 Participants |
| 2. Awake Extubation/Placebo | Number of Participants With Postoperative Nausea and Vomiting (PONV) | 6 Participants |
| 3.Deep Extubation/Dexmedetomidine | Number of Participants With Postoperative Nausea and Vomiting (PONV) | 6 Participants |
| 4. Deep Extubation/Placebo | Number of Participants With Postoperative Nausea and Vomiting (PONV) | 3 Participants |
Secondary
Number of Patients With Unplanned Hospital Admission
Any unplanned hospital admission due to perioperative respiratory adverse events.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | Number of Patients With Unplanned Hospital Admission | 0 Participants |
| 2. Awake Extubation/Placebo | Number of Patients With Unplanned Hospital Admission | 2 Participants |
| 3.Deep Extubation/Dexmedetomidine | Number of Patients With Unplanned Hospital Admission | 0 Participants |
| 4. Deep Extubation/Placebo | Number of Patients With Unplanned Hospital Admission | 0 Participants |
Secondary
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
Time frame: 24 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1. Awake Extubation/Dexmedetomidine | The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) | 345.06 Minutes | Standard Deviation 91.23 |
| 2. Awake Extubation/Placebo | The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) | 320.19 Minutes | Standard Deviation 69.07 |
| 3.Deep Extubation/Dexmedetomidine | The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) | 341.53 Minutes | Standard Deviation 73.85 |
| 4. Deep Extubation/Placebo | The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission) | 328.05 Minutes | Standard Deviation 93.97 |