Emergency Agitation in T&A

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01152476
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: remifentanil; Drug: normal saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group SR	Drug: remifentanil; General anesthesia is maintained witn sevoflurane and remifentanil.
Active Comparator: group S	Drug: normal saline; General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil

Outcome Measures

Primary Outcome Measures

1. emergency agitation [during 1 hour after recovering of anesthesia]

   at post-anesthetic care unit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologist physical status I or II

• 2-6 year-old children

• patients undergoing tonsillectomy and adenoidectomy

Exclusion Criteria:

• upper respiratory disease

• mental retardation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01152476
• Other Study ID Numbers: T&A_EA
• First Posted: Jun 29, 2010
• Last Update Posted: Jan 6, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: healthy pediatric patients undergoing tonsillectomy and adenoidectomy
• Additional relevant MeSH terms: Remifentanil

Study Results

No Results Posted as of Jan 6, 2011