Trial Outcomes & Findings for The Effect of Dexmedetomidine on Airway Complications After Deep or Awake Extubation (NCT NCT02162433)
NCT ID: NCT02162433
Last Updated: 2020-04-09
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
92 participants
Primary outcome timeframe
24 hours
Results posted on
2020-04-09
Participant Flow
Participant milestones
| Measure |
1. Awake Extubation/Dexmedetomidine
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
23
|
23
|
|
Overall Study
COMPLETED
|
22
|
21
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1. Awake Extubation/Dexmedetomidine
n=23 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=23 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=23 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=23 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
92 Participants
n=92 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=92 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=92 Participants
|
|
Age, Continuous
|
6.64 years
STANDARD_DEVIATION 3.21 • n=23 Participants
|
6.1 years
STANDARD_DEVIATION 2.89 • n=23 Participants
|
6.52 years
STANDARD_DEVIATION 2.79 • n=23 Participants
|
6.64 years
STANDARD_DEVIATION 2.8 • n=23 Participants
|
6.48 years
STANDARD_DEVIATION 2.94 • n=92 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=23 Participants
|
9 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
9 Participants
n=23 Participants
|
39 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=23 Participants
|
14 Participants
n=23 Participants
|
11 Participants
n=23 Participants
|
14 Participants
n=23 Participants
|
53 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
23 participants
n=23 Participants
|
92 participants
n=92 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNumber 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.
Outcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Number of Participants With Respiratory Complications
|
13 Participants
|
15 Participants
|
13 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber 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.
Outcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Number of Participants With Emergence Agitation
|
7 Participants
|
13 Participants
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 24 hrsNumber of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.
Outcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Number of Participants With Postoperative Nausea and Vomiting (PONV)
|
5 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Average Time From End of Surgery to Leaving the Operating Room
|
19.15 Minutes
Standard Deviation 5.5
|
18.05 Minutes
Standard Deviation 7.43
|
10.29 Minutes
Standard Deviation 3.73
|
11.77 Minutes
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: 24 hrsOutcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)
|
345.06 Minutes
Standard Deviation 91.23
|
320.19 Minutes
Standard Deviation 69.07
|
341.53 Minutes
Standard Deviation 73.85
|
328.05 Minutes
Standard Deviation 93.97
|
SECONDARY outcome
Timeframe: 24 hours24-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.
Outcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Number of Participants Needing Follow-up Pain Medication
|
18 Participants
|
17 Participants
|
20 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 24 hoursAny unplanned hospital admission due to perioperative respiratory adverse events.
Outcome measures
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 Participants
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 Participants
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 Participants
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 Participants
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Number of Patients With Unplanned Hospital Admission
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
1. Awake Extubation/Dexmedetomidine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
2. Awake Extubation/Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
3.Deep Extubation/Dexmedetomidine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
4. Deep Extubation/Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1. Awake Extubation/Dexmedetomidine
n=22 participants at risk
Awake extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
2. Awake Extubation/Placebo
n=21 participants at risk
Awake extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
3.Deep Extubation/Dexmedetomidine
n=21 participants at risk
Deep extubation receiving dexmedetomidine.
Dexmedetomidine: to arms 1,3
|
4. Deep Extubation/Placebo
n=22 participants at risk
Deep extubation receiving placebo (normal saline).
Normal Saline: to arms 2,4. Serves as the placebo.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Post-extubation persistent cough
|
22.7%
5/22 • Number of events 5 • 24 hours post-op
|
28.6%
6/21 • Number of events 6 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
18.2%
4/22 • Number of events 4 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
PACU persistent cough
|
13.6%
3/22 • Number of events 3 • 24 hours post-op
|
23.8%
5/21 • Number of events 5 • 24 hours post-op
|
38.1%
8/21 • Number of events 8 • 24 hours post-op
|
40.9%
9/22 • Number of events 9 • 24 hours post-op
|
|
Blood and lymphatic system disorders
Post-extubation low SaO2
|
27.3%
6/22 • Number of events 6 • 24 hours post-op
|
19.0%
4/21 • Number of events 4 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
|
Blood and lymphatic system disorders
PACU low SaO2
|
27.3%
6/22 • Number of events 6 • 24 hours post-op
|
28.6%
6/21 • Number of events 6 • 24 hours post-op
|
38.1%
8/21 • Number of events 8 • 24 hours post-op
|
31.8%
7/22 • Number of events 7 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
|
General disorders
Nausea/Vomiting
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
9.1%
2/22 • Number of events 2 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
Post-Extubation Stridor
|
0.00%
0/22 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
13.6%
3/22 • Number of events 3 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
PACU stridor
|
0.00%
0/22 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
9.5%
2/21 • Number of events 2 • 24 hours post-op
|
9.1%
2/22 • Number of events 2 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
Post-Extubation Croup
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
0.00%
0/22 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
PACU Croup
|
0.00%
0/22 • 24 hours post-op
|
9.5%
2/21 • Number of events 2 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
13.6%
3/22 • Number of events 3 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
Post-Extubation Breath Holding
|
0.00%
0/22 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
|
Respiratory, thoracic and mediastinal disorders
PACU Breath Holding
|
0.00%
0/22 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
14.3%
3/21 • Number of events 3 • 24 hours post-op
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
|
Blood and lymphatic system disorders
Tonsil Bleed
|
4.5%
1/22 • Number of events 1 • 24 hours post-op
|
0.00%
0/21 • 24 hours post-op
|
4.8%
1/21 • Number of events 1 • 24 hours post-op
|
0.00%
0/22 • 24 hours post-op
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place