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Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children

Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00857727
Acronym
DexPeds
Enrollment
33
Registered
2009-03-09
Start date
2009-08-31
Completion date
2011-12-31
Last updated
2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation, Anesthesia, Pediatrics

Keywords

Dexmedetomidine, Emergence Delirium, Agitation, Pediatric, Anesthesia

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.

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.

Interventions

DRUGDexmedetomidine

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

DRUGSaline

Given by a continuous infusion

Sponsors

St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 17 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Emergence Delirium15-45 minutes post-opEmergence 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

MeasureTime frameDescription
WeightBaseline
Length of AnesthesiaDay 1
Length of SurgeryDay 1
Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU24 hoursVital signs were not collected as part of research study.
Total SevofluraneDay 1Total Drug used
Total PropofolDay 1Total Drug used
Total FentanylDay 1Total Drug used
Total Study DrugDay 1Total Study Drug used

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Drug
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.
14
Control
Normal Saline IV solution - Given by a continuous infusion
14
Total28

Baseline characteristics

CharacteristicDrugControlTotal
Age, Continuous5.2 years
STANDARD_DEVIATION 2.6
4.2 years
STANDARD_DEVIATION 2.7
4.7 years
STANDARD_DEVIATION 2.8
Sex: Female, Male
Female
7 Participants6 Participants13 Participants
Sex: Female, Male
Male
7 Participants8 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 140 / 14
serious
Total, serious adverse events
1 / 141 / 14

Outcome results

Primary

Number of Participants With Emergence Delirium

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

ArmMeasureGroupValue (NUMBER)
DrugNumber of Participants With Emergence DeliriumED1 participants
DrugNumber of Participants With Emergence DeliriumNo ED13 participants
ControlNumber of Participants With Emergence DeliriumED7 participants
ControlNumber of Participants With Emergence DeliriumNo ED7 participants
Secondary

Length of Anesthesia

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
DrugLength of Anesthesia199 minutesStandard Deviation 71
ControlLength of Anesthesia215 minutesStandard Deviation 156
Secondary

Length of Surgery

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
DrugLength of Surgery58 minutesStandard Deviation 43
ControlLength of Surgery86 minutesStandard Deviation 149
Secondary

Total Fentanyl

Total Drug used

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
DrugTotal Fentanyl2.33 mcg/kgStandard Deviation 0.79
ControlTotal Fentanyl2.36 mcg/kgStandard Deviation 0.99
Secondary

Total Propofol

Total Drug used

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
DrugTotal Propofol2.11 mg/kgStandard Deviation 1.28
ControlTotal Propofol2.41 mg/kgStandard Deviation 1.36
Secondary

Total Sevoflurane

Total Drug used

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
DrugTotal Sevoflurane3.67 ml/kgStandard Deviation 1.38
ControlTotal Sevoflurane6.80 ml/kgStandard Deviation 7.81
Secondary

Total Study Drug

Total Study Drug used

Time frame: Day 1

ArmMeasureValue (MEAN)Dispersion
DrugTotal Study Drug1.55 mcg/kgStandard Deviation 0.32
ControlTotal Study Drug1.43 mcg/kgStandard Deviation 0.32
Secondary

Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU

Vital signs were not collected as part of research study.

Time frame: 24 hours

Population: data were not collected

Secondary

Weight

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
DrugWeight21.8 kgStandard Deviation 7.3
ControlWeight18.5 kgStandard Deviation 8.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026