DexPeds: Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00857727
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 28
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical population.

Condition or Disease	Intervention/Treatment	Phase
Agitation; Anesthesia; Pediatrics	Drug: Dexmedetomidine; Drug: Saline	Phase 3

Detailed Description

Emergence delirium from general anesthesia is a common problem in the pediatric population with a reported incidence of up to 80%. In addition to being jarring to children and their parents, ED can cause significant physical harm, particularly to the surgical site. ED is also associated with accidental removal of surgical dressings and drains, intravenous and intra-arterial catheters, increased nursing care, extended recovery room stays, and delayed reunion with parents. Emergence delirium is especially associated with sevoflurane, the most commonly used inhalation anesthetic in pediatrics. At present, there is no single definition of pediatric ED because of its heterogeneous clinical presentation. It has been described as an acute phenomenon in which the child is irritable, uncompromising, uncooperative, incoherent, and inconsolably crying, moaning, kicking or thrashing. Typically, these children do not recognize or identify familiar objects or people, and often exhibit combative behavior. Although ED is a self-limiting phenomenon, it is especially dangerous in the interventional neuroradiologic patient whose femoral artery has been catheterized and must be kept immobile in the immediate post-operative period. These patients also have multiple intravenous and intra-arterial catheters which can be dislodged during an episode of ED. Numerous pharmacologic agents including benzodiazepines, opioids, ketamine, and clonidine, have been studied as prophylactic agents for ED but have met with varying success. Promising results with the α-2 adrenergic agonist clonidine, have spurred interest in a new α-2 adrenergic agonist, dexmedetomidine.

Dexmedetomidine is highly selective for the 2A subtype of the central presynaptic α-2 adrenergic receptor which is associated with sedation and analgesia. It is currently approved for use in adults as a sedative agent in intensive care units but has been used in myriad other ways for sedation. As a sedative, dexmedetomidine is unusual in that it does not depress respiratory drive because its actions are not mediated by the GABA-mimetic system. The quality of sedation produced by dexmedetomidine is unique, and has been described as "cooperative sedation," in which patients can interact with healthcare providers and follow verbal commands. This particular sedation profile permits a patient to be comfortably sedated, yet cooperate for an accurate neurological exam. The most extreme example of this is the awake craniotomy, in which a patient undergoes a neurological examination during surgery. In addition to being sedative, dexmedetomidine is also analgesic and suppresses shivering, making it especially useful in the perioperative period.

There have been studies suggesting a use for dexmedetomidine in ED yet none have examined its use in the pediatric neurosurgical population. Treatment of ED in pediatric neurosurgical patients involves balancing the need for smooth emergence with the need for accurate neurological exams. Benzodiazepines and opioids are currently used to treat ED but are long-acting, interfere with neurological exams, and carry the risks of respiratory depression, nausea, vomiting, and acute tolerance. Dexmedetomidine provides an alternative to current treatment modalities for ED, which does not interfere with neurological exams.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug Dexmedetomidine	Drug: Dexmedetomidine; Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg; Other Names: Precedex
Placebo Comparator: Control Normal Saline IV solution	Drug: Saline; Given by a continuous infusion; Other Names: Phosphate buffered saline PBS

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Emergence Delirium [15-45 minutes post-op]

   Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).

Secondary Outcome Measures

1. Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU [24 hours]

   Vital signs were not collected as part of research study.

2. Weight [Baseline]

3. Length of Anesthesia [Day 1]

4. Length of Surgery [Day 1]

5. Total Study Drug [Day 1]

   Total Study Drug used

6. Total Sevoflurane [Day 1]

   Total Drug used

7. Total Propofol [Day 1]

   Total Drug used

8. Total Fentanyl [Day 1]

   Total Drug used

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children age 6 months through 17 years of age undergoing interventional neuroradiologic procedures at our hospital under general anesthesia

• Patients classify as an ASA (American Society of Anesthesiologists) I-III

• Have not received anesthetic for over 30 days from previous procedures

Exclusion Criteria:

• Receiving digoxin therapy from the study

• Severe congestive heart failure or pulmonary hypertension requiring vasodilators

• Disease processes other than that associated with their intracranial pathology, such as hepatic or renal dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Luke's-Roosevelt Hospital Center	New York	New York	United States	10019

Sponsors and Collaborators

• St. Luke's-Roosevelt Hospital Center

Investigators

• Principal Investigator: Jolie Narang, M.D., St. Luke's-Roosevelt Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6.
• Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6.
• Ibacache ME, Muñoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.
• Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. Erratum in: Paediatr Anaesth. 2006 Jul;16(7):811.
• Walker J, Maccallum M, Fischer C, Kopcha R, Saylors R, McCall J. Sedation using dexmedetomidine in pediatric burn patients. J Burn Care Res. 2006 Mar-Apr;27(2):206-10.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT00857727
• Other Study ID Numbers: Dex Peds 08-088
• First Posted: Mar 9, 2009
• Last Update Posted: Nov 27, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Dexmedetomidine; Emergence Delirium; Agitation; Pediatric; Anesthesia
• Additional relevant MeSH terms: Delirium; Psychomotor Agitation; Emergence Delirium; Dexmedetomidine

Study Results

Participant Flow

Recruitment Details	33 children undergoing general anesthesia for endovascular interventional procedures. 28 patients provided complete data sets.

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Period Title: Overall Study
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Drug	Control	Total
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.2 (2.6)	4.2 (2.7)	4.7 (2.8)
Sex: Female, Male (Count of Participants)
Female	7 50%	6 42.9%	13 46.4%
Male	7 50%	8 57.1%	15 53.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Emergence Delirium
Description	Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).
Time Frame	15-45 minutes post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
ED	1 7.1%	7 50%
No ED	13 92.9%	7 50%

2. Secondary Outcome

Title	Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU
Description	Vital signs were not collected as part of research study.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

data were not collected

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	0	0

3. Secondary Outcome

Title	Weight
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [kg]	21.8 (7.3)	18.5 (8.1)

4. Secondary Outcome

Title	Length of Anesthesia
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [minutes]	199 (71)	215 (156)

5. Secondary Outcome

Title	Length of Surgery
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [minutes]	58 (43)	86 (149)

6. Secondary Outcome

Title	Total Study Drug
Description	Total Study Drug used
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [mcg/kg]	1.55 (0.32)	1.43 (0.32)

7. Secondary Outcome

Title	Total Sevoflurane
Description	Total Drug used
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [ml/kg]	3.67 (1.38)	6.80 (7.81)

8. Secondary Outcome

Title	Total Propofol
Description	Total Drug used
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [mg/kg]	2.11 (1.28)	2.41 (1.36)

9. Secondary Outcome

Title	Total Fentanyl
Description	Total Drug used
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Drug	Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.	Normal Saline IV solution - Given by a continuous infusion
Measure Participants	14	14
Mean (Standard Deviation) [mcg/kg]	2.33 (0.79)	2.36 (0.99)

Adverse Events

Adverse Event Reporting Description	Two adverse events were noted requiring unblinding
Arm/Group Title	Drug		Control
Arm/Group Description	Dexmedetomidine - An initial dose, given one hour prior to extubation of 1.0 µg/kg over 20 minutes, followed by a continuous infusion at 0.5 µg/kg/hour, continuing for 30 minutes following extubation.		Normal Saline IV solution - Given by a continuous infusion
All Cause Mortality
	Drug		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Drug		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		1/14 (7.1%)
Cardiac disorders
Severe bradycardia	0/14 (0%)	0	1/14 (7.1%)	1
General disorders
Excessive sedation	1/14 (7.1%)	1	0/14 (0%)	0
Other (Not Including Serious) Adverse Events
	Drug		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

Methodology used cannot determine whether undescribed prolonged effect of DEX is related to the DEX or to increased activity levels in the placebo group.

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.