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OpenTrials
Completed

NCT Number: NCT01901588

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

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

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Key information

About this study

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:

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

Exclusion:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

Other names: Precedex

Placebo

Other

intraoperative dose of intravenous placebo

Other names: saline solution

Primary outcomes

  1. Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery

    Time frame: Length of PACU stay (around 3 hours on average)

Secondary outcomes

  1. Percentage of Participants Receiving Pain Medication

    Time frame: Length of PACU stay (around 3 hours on average)

  2. Post-op Pain Interventions

    Time frame: Length of PACU stay (around 3 hours on average)

  3. Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications

    Time frame: Length of PACU stay (around 3 hours on average)

  4. Time to Arousal

    Time frame: Length of PACU stay (around 3 hours on average)

  5. Time to PACU Discharge

    Time frame: Length of PACU stay (around 3 hours on average)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Jul 17, 2013
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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