CClinicalTrials.gg
CompletedNCT00857727DexPedsUpdated Nov 27, 2018Results posted

Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children

A Phase 3 interventional study of Dexmedetomidine and Saline in Agitation, Anesthesia and Pediatrics, sponsored by St. Luke's-Roosevelt Hospital Center. Completed at 1 site in United States. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2018-11-27.

Sponsored by St. Luke's-Roosevelt Hospital Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
6 Months to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Agitation
  • Anesthesia
  • Pediatrics

Keywords

  • Dexmedetomidine
  • Emergence Delirium
  • Agitation
  • Pediatric
  • Anesthesia
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 33 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

St. Luke's-Roosevelt Hospital Center is the lead sponsor of 68 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Drug

    Dexmedetomidine

    Drug: Dexmedetomidine

  • Placebo comparator
    Control

    Normal Saline IV solution

    Drug: Saline

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

    Also known as: Precedex

  • DrugSaline

    Given by a continuous infusion

    Also known as: Phosphate buffered saline, PBS

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Weight

    Time frame: Baseline

  3. Length of Anesthesia

    Time frame: Day 1

  4. Length of Surgery

    Time frame: Day 1

  5. Total Study Drug

    Total Study Drug used

    Time frame: Day 1

  6. Total Sevoflurane

    Total Drug used

    Time frame: Day 1

  7. Total Propofol

    Total Drug used

    Time frame: Day 1

  8. Total Fentanyl

    Total Drug used

    Time frame: Day 1

07

Results

Posted Nov 27, 2018
Limitations and 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.

Participant flow

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

Participant flow — Overall Study
MilestoneDrugControl
Started1414
Completed1414
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Number · participants
Number of Participants With Emergence Delirium
participantsDrugControl
ED17
No ED137
SecondaryVital 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

No measurements were reported for this outcome.

SecondaryWeight
Time frame:
Baseline
Reported as:
Mean · kg
Weight
kgDrugControl
Weight21.8 ± 7.318.5 ± 8.1
SecondaryLength of Anesthesia
Time frame:
Day 1
Reported as:
Mean · minutes
Length of Anesthesia
minutesDrugControl
Length of Anesthesia199 ± 71215 ± 156
SecondaryLength of Surgery
Time frame:
Day 1
Reported as:
Mean · minutes
Length of Surgery
minutesDrugControl
Length of Surgery58 ± 4386 ± 149
SecondaryTotal Study Drug

Total Study Drug used

Time frame:
Day 1
Reported as:
Mean · mcg/kg
Total Study Drug
mcg/kgDrugControl
Total Study Drug1.55 ± 0.321.43 ± 0.32
SecondaryTotal Sevoflurane

Total Drug used

Time frame:
Day 1
Reported as:
Mean · ml/kg
Total Sevoflurane
ml/kgDrugControl
Total Sevoflurane3.67 ± 1.386.80 ± 7.81
SecondaryTotal Propofol

Total Drug used

Time frame:
Day 1
Reported as:
Mean · mg/kg
Total Propofol
mg/kgDrugControl
Total Propofol2.11 ± 1.282.41 ± 1.36
SecondaryTotal Fentanyl

Total Drug used

Time frame:
Day 1
Reported as:
Mean · mcg/kg
Total Fentanyl
mcg/kgDrugControl
Total Fentanyl2.33 ± 0.792.36 ± 0.99

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Drug—1/14 (7.1%)0/14 (0%)
Control—1/14 (7.1%)0/14 (0%)
Most frequent serious events
Most frequent serious events
EventDrugControl
Severe bradycardiaCardiac disorders0/141/14
Excessive sedationGeneral disorders1/140/14

Baseline characteristics

Age, Continuous
Age, Continuous(years)DrugControlTotal
Mean5.2 ± 2.64.2 ± 2.74.7 ± 2.8
Sex: Female, Male
Sex: Female, Male(Participants)DrugControlTotal
Female7613
Male7815
08

Study locations

1 site
  • St Luke's-Roosevelt Hospital Center
    New York, New York 10019, United States
09

References and documents

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. doi: 10.1111/j.1460-9592.2006.02100.x. PubMed 17359402 ↗
  • 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. doi: 10.1111/j.1460-9592.2006.01845.x. Erratum In: Paediatr Anaesth. 2006 Jul;16(7):811. PubMed 16879517 ↗
  • 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. doi: 10.1111/j.1460-9592.2004.01541.x. PubMed 16101707 ↗
  • Ibacache ME, Munoz 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. PubMed 14693585 ↗
  • 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. doi: 10.1097/01.BCR.0000200910.76019.CF. PubMed 16566567 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00857727
Lead sponsor
St. Luke's-Roosevelt Hospital Center
Responsible party
Sponsor
First posted
Mar 9, 2009
Start date
Aug 2009
Primary completion
Nov 2011
Completion
Dec 2011
Results posted
Nov 27, 2018
Last update
Nov 27, 2018

Study contacts

Jolie Narang, M.D.
principal investigator · St. Luke's-Roosevelt Hospital Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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