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NCT00990769 · ClinicalTrials.gov registry record · NA

The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT00990769: Completed NA study, sponsored by Duke University.

NCT00990769 is a NA study that has completed, run by Duke University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00990769, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.

Primary Outcome

The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.

Interventions

  • OTHER Depth of anesthesia

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2009-09
Est. Completion 2010-09
Phase NA
Duke University

1,725 total trials

What the finished NCT00990769 record still lists

NCT00990769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Depth of anesthesia is the first listed.

NCT00990769 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00990769 about?

NCT00990769 is a clinical study titled "The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children". The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not b...

What is the current status of trial NCT00990769?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-09. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00990769?

The interventions under investigation include: Depth of anesthesia (OTHER).

Who is sponsoring clinical trial NCT00990769?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00990769's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00990769, the US trial registry maintained by the National Library of Medicine. NCT00990769 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.