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

NCT ID: NCT01901588

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-05-31

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.

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:

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

Conditions

Strabismus; Delirium on Emergence; Pediatric Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine

dexmedetomidine/precedex

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

Placebo

patients receive saline solution.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

intraoperative dose of intravenous placebo

Interventions

Dexmedetomidine

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

Intervention Type: DRUG

Placebo

intraoperative dose of intravenous placebo

Intervention Type: OTHER

Other Intervention Names

Precedex; saline solution

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Brown, MD

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

S12-00556

Identifier Type: -

Identifier Source: org_study_id