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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01464489
Other study ID # AJIRB-MED-CT4-11-074
Secondary ID
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


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
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