Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy

Ankyloglossia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550354
• Other study ID #: 4-2011-0824
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ankyloglossia

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.