A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block
A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This study was performed to compare the incidence of EA between two dose of sevoflurane for sedation with caudal block in children, and intended to find the optimal dose for prevention of sevoflurane induced emergence agitation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedFirst Submitted
Initial submission to the registry
April 21, 2017
CompletedFirst Posted
Study publicly available on registry
May 1, 2017
CompletedMay 1, 2017
April 1, 2017
7 months
April 21, 2017
April 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
postoperative agitation score
Four-point agitation scale
5 minutes in the recovery room
postoperative agitation score
Four-point agitation scale
30 minutes in the recovery room
postoperative agitation score
Pediatric Anesthesia Emergence Delirium (PAED) scale
5 minutes in the recovery room
postoperative agitation score
Pediatric Anesthesia Emergence Delirium (PAED) scale
30 minutes in the recovery room
Study Arms (2)
low volume volatile anesthetics
ACTIVE COMPARATOR1.0 % sevoflurane sedation via face mask , low dose sevoflurane group
high volume volatile anesthetics
ACTIVE COMPARATOR2.5 % sevoflurane sedation via face mask, high dose sevoflurane group
Interventions
low volume volatile anesthetics (1.0%)
high volume volatile anesthetics (2.5%)
Eligibility Criteria
You may qualify if:
- patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1
You may not qualify if:
- Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
PMID: 15114210RESULTAono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.
PMID: 9416712RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun kyung Choi, MD,PhD
Yeungnam University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 21, 2017
First Posted
May 1, 2017
Study Start
June 1, 2016
Primary Completion
December 31, 2016
Study Completion
February 28, 2017
Last Updated
May 1, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will share