Intubation Time With Low Dose Rocuronium

Intubation; Difficult Clinical Trial

Official title:

Study of Intubation Time Required for Excellent Tracheal Intubation With Low Dose Rocuronium During Propofol Anaesthesia in Children With and Without Atropine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464489
• Other study ID #: AJIRB-MED-CT4-11-074
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: November 1, 2011
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesized that increasing the cardiac output by use of atropine in children might result in a reduction of the intubation time needed to facilitate tracheal intubation.

Description:

The investigators hypothesized that increasing the cardiac output by use of atropine in children might result in a reduction of the intubation time needed to facilitate tracheal intubation. Therefore, the purpose of this study was to determine TimeEI with a low dose of esmeron (rocuronium) (0.3 mg.kg-1) for achievement of successful tracheal intubation conditions during intravenous (i.v.) anaesthesia using propofol and alfentanil in children and to determine whether administration of i.v. atropine (atropine sulphate) (10 μg.kg-1) during anaesthesia induction reduced these times.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I,

• Tonsillectomy with adenoidectomy

Exclusion Criteria:

• Patients with known allergy to the drugs used in this study,

• A history of reactive airway disease and asthma,

• A neuromuscular disorder, an anticipated difficult airway, and

• Crying children on arrival in the operating theatre

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Drug:
• Atropine
Anaesthesia was induced with alfentanil 10 µg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1. Atropine(atropine sulphate) 10 µg.kg-1, intravenous injection during induction After 120 sec of atropine injection, record intubating condition
• Normal saline
Anaesthesia was induced with alfentanil 10 µg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1 Normal saline intravenous injection during anesthetic induction After 120 sec of normal saline injection, record intubating condition

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Stoddart PA, Mather SJ. Onset of neuromuscular blockade and intubating conditions one minute after the administration of rocuronium in children. Paediatr Anaesth. 1998;8(1):37-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intubation time	Tracheal intubation was attempted was predetermined according to the up-and-down method, starting with 120 s, in both groups. If intubation was successful (unsuccessful), the assigned intubation time was decreased (increased) by one interval for the next patients in that group, respectively. In this study, the investigators adopted 69, 83, 99, 120, 144, 173, and 208 s, since these intubation times have equal intervals (0.08) on a logarithmic scale.	intubating condition at 120 seconds from rocuronium injection	Yes