Trial Outcomes & Findings for Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery (NCT NCT01901588)
NCT ID: NCT01901588
Last Updated: 2016-07-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
Length of PACU stay (around 3 hours on average)
Results posted on
2016-07-11
Participant Flow
Patient's familes were approached on the day of surgery and spoken to privately in the pre-op area. Fliers were placed at the phthalmalogist's offices so were generally aware of the study ahead of time.
Participant milestones
| Measure |
Dexmedetomidine
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=32 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=31 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black, Not of Hispanic-American Origin
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic-American
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic-American Origin
|
23 participants
n=99 Participants
|
22 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Length of PACU stay (around 3 hours on average)Outcome measures
| Measure |
Dexmedetomidine
n=26 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=29 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery
|
50 percentage of participants
|
48 percentage of participants
|
SECONDARY outcome
Timeframe: Length of PACU stay (around 3 hours on average)Outcome measures
| Measure |
Dexmedetomidine
n=26 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=29 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Percentage of Participants Receiving Pain Medication
|
50 percentage of participants
|
66 percentage of participants
|
SECONDARY outcome
Timeframe: Length of PACU stay (around 3 hours on average)Outcome measures
| Measure |
Dexmedetomidine
n=26 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=29 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Post-op Pain Interventions
|
18 number of pain interventions/group
|
30 number of pain interventions/group
|
SECONDARY outcome
Timeframe: Length of PACU stay (around 3 hours on average)Outcome measures
| Measure |
Dexmedetomidine
n=26 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=29 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications
|
0 percentage of participants
|
14 percentage of participants
|
SECONDARY outcome
Timeframe: Length of PACU stay (around 3 hours on average)Outcome measures
| Measure |
Dexmedetomidine
n=26 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=29 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Time to Arousal
|
60 minutes
Standard Deviation 36
|
40 minutes
Standard Deviation 39
|
SECONDARY outcome
Timeframe: Length of PACU stay (around 3 hours on average)Outcome measures
| Measure |
Dexmedetomidine
n=26 Participants
dexmedetomidine/precedex
Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
|
Placebo
n=29 Participants
patients receive saline solution.
Placebo: intraoperative dose of intravenous placebo
|
|---|---|---|
|
Time to PACU Discharge
|
186 minutes
Standard Deviation 64
|
173 minutes
Standard Deviation 60
|
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Professor, Department of Anesthesiology, Perioperative Care, and Pain Medicine
NYU School of Medicine
Phone: 212.263.5072
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place