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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01550354
Other study ID # 4-2011-0824
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date January 2014

Study information

Verified date June 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Several methods have been demonstrated to improve intubating conditions during sevoflurane induction in children. These include opioids, propofol, and addition of neuromuscular blocking agents in pediatric patients. But the study about the comparison of these agents has been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure performed under general anesthesia. The investigators aimed to compare intubating conditions among children with propofol, alfentanil or rocuronium after sevoflurane induction.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 1 Year to 9 Years
Eligibility Inclusion Criteria: - Children, 1-9 years old scheduled elective frenectomy under general anesthesia Exclusion Criteria: - Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
administration of propofol
intravenous administration of propofol 2 mg/kg before intubation
administration of alfentanil
intravenous administration of alfentanil 14 µg/kg before intubation
administration of rocuronium
Intravenous administration of rocuronium 0.3 mg/kg before intubation

Locations

Country Name City State
Korea, Republic of Severance hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Park S, Kim JH, Chan Bae J, Lee JR, Kim MS. Tracheal intubation with or without a neuromuscular blocking agent for a short surgical procedure in children : Prospective, randomized, double-blind trial. Paediatr Anaesth. 2021 May 16. doi: 10.1111/pan.14205. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intubating condition The investigators will perform the evaluation of intubating condtion through scoring system provided by Viby-Mogensen during intubation procedure. The scoring system is consisted of excellent, good, and poor. Participants will be followed for the duration of intubation, an expected average of 1 minute.
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