Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01901588
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Duration (Months): 50
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

Condition or Disease	Intervention/Treatment	Phase
Strabismus; Delirium on Emergence; Pediatric Disorders	Drug: Dexmedetomidine; Other: Placebo	Phase 4

Detailed Description

Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.

Inclusion:

1. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities

Exclusion:

1. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine dexmedetomidine/precedex	Drug: Dexmedetomidine; intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes; Other Names: Precedex
Placebo Comparator: Placebo patients receive saline solution.	Other: Placebo; intraoperative dose of intravenous placebo; Other Names: saline solution

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery [Length of PACU stay (around 3 hours on average)]

Secondary Outcome Measures

1. Percentage of Participants Receiving Pain Medication [Length of PACU stay (around 3 hours on average)]

2. Post-op Pain Interventions [Length of PACU stay (around 3 hours on average)]

3. Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications [Length of PACU stay (around 3 hours on average)]

4. Time to Arousal [Length of PACU stay (around 3 hours on average)]

5. Time to PACU Discharge [Length of PACU stay (around 3 hours on average)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA physical status of I or II

• male or female, aged 1-7

• has no significant lab abnormalities

Exclusion Criteria:

• ASA physical status of III, IV or V

• Presence of medicated behavioral disorder

• Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.

• Parental refusal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Medical Center	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Jason Brown, MD, NYU School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT01901588
• Other Study ID Numbers: S12-00556
• First Posted: Jul 17, 2013
• Last Update Posted: Jul 11, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by NYU Langone Health: strabismus; pediatric; emergence delirium; precedex/dexmedetomidine
• Additional relevant MeSH terms: Delirium; Strabismus; Emergence Delirium; Dexmedetomidine

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Period Title: Overall Study
STARTED	32	31
COMPLETED	32	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dexmedetomidine	Placebo	Total
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo	Total of all reporting groups
Overall Participants	32	31	63
Age (Count of Participants)
<=18 years	32 100%	31 100%	63 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 37.5%	16 51.6%	28 44.4%
Male	20 62.5%	15 48.4%	35 55.6%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaskan	0 0%	0 0%	0 0%
Asian or Pacific Islander	1 3.1%	2 6.5%	3 4.8%
Black, Not of Hispanic-American Origin	2 6.3%	1 3.2%	3 4.8%
Hispanic-American	1 3.1%	0 0%	1 1.6%
White, not of Hispanic-American Origin	23 71.9%	22 71%	45 71.4%
Other or Unknown	5 15.6%	6 19.4%	11 17.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery
Time Frame	Length of PACU stay (around 3 hours on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Measure Participants	26	29
Number [percentage of participants]	50 156.3%	48 154.8%

2. Secondary Outcome

Title	Percentage of Participants Receiving Pain Medication
Time Frame	Length of PACU stay (around 3 hours on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Measure Participants	26	29
Number [percentage of participants]	50 156.3%	66 212.9%

3. Secondary Outcome

Title	Post-op Pain Interventions
Time Frame	Length of PACU stay (around 3 hours on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Measure Participants	26	29
Number [number of pain interventions/group]	18	30

4. Secondary Outcome

Title	Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications
Time Frame	Length of PACU stay (around 3 hours on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Measure Participants	26	29
Number [percentage of participants]	0 0%	14 45.2%

5. Secondary Outcome

Title	Time to Arousal
Time Frame	Length of PACU stay (around 3 hours on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Measure Participants	26	29
Mean (Standard Deviation) [minutes]	60 (36)	40 (39)

6. Secondary Outcome

Title	Time to PACU Discharge
Time Frame	Length of PACU stay (around 3 hours on average)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine	Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
Measure Participants	26	29
Mean (Standard Deviation) [minutes]	186 (64)	173 (60)

Adverse Events

Arm/Group Title	Dexmedetomidine		Placebo
Arm/Group Description	dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes		patients receive saline solution. Placebo: intraoperative dose of intravenous placebo
All Cause Mortality
	Dexmedetomidine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexmedetomidine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Dexmedetomidine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.