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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01901588

Enrollment

Registered

2013-07-17

Start date

2012-03-31

Completion date

2016-05-31

Last updated

2016-07-11

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

Conditions

Delirium on Emergence, Pediatric Disorders, Strabismus

Keywords

strabismus, pediatric, emergence delirium, precedex/dexmedetomidine

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

Interventions

DRUGDexmedetomidine

intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes

OTHERPlacebo

intraoperative dose of intravenous placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 7 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery	Length of PACU stay (around 3 hours on average)

Secondary

Measure	Time frame
Percentage of Participants Receiving Pain Medication	Length of PACU stay (around 3 hours on average)
Post-op Pain Interventions	Length of PACU stay (around 3 hours on average)
Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications	Length of PACU stay (around 3 hours on average)
Time to Arousal	Length of PACU stay (around 3 hours on average)
Time to PACU Discharge	Length of PACU stay (around 3 hours on average)

Countries

United States

Participant flow

Recruitment details

Patient's familes were approached on the day of surgery and spoken to privately in the pre-op area. Fliers were placed at the phthalmalogist's offices so were generally aware of the study ahead of time.

Participants by arm

Arm	Count
Dexmedetomidine dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes	32
Placebo patients receive saline solution. Placebo: intraoperative dose of intravenous placebo	31
Total	63

Baseline characteristics

Characteristic	Dexmedetomidine	Placebo	Total
Age, Categorical <=18 years	32 Participants	31 Participants	63 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized American Indian or Alaskan	0 participants	0 participants	0 participants
Race/Ethnicity, Customized Asian or Pacific Islander	1 participants	2 participants	3 participants
Race/Ethnicity, Customized Black, Not of Hispanic-American Origin	2 participants	1 participants	3 participants
Race/Ethnicity, Customized Hispanic-American	1 participants	0 participants	1 participants
Race/Ethnicity, Customized Other or Unknown	5 participants	6 participants	11 participants
Race/Ethnicity, Customized White, not of Hispanic-American Origin	23 participants	22 participants	45 participants
Sex: Female, Male Female	12 Participants	16 Participants	28 Participants
Sex: Female, Male Male	20 Participants	15 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 32	0 / 31
serious Total, serious adverse events	0 / 32	0 / 31