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Intubation Time With Low Dose Rocuronium

NCT01464489 — Not applicable, Completed, 44 participants, Gachon University Gil Medical Center

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

RegistryNCT01464489
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single
Enrollment44 (Actual)
SponsorGachon University Gil Medical Center (Other)
ConditionsIntubation; Difficult
InterventionsAtropine, Normal saline (Drug)
Datesstart 2011-05-01, primary completion 2011-09-01, completion 2011-09-01, first posted 2011-11-03, last updated 2011-11-03
Locations1 site in South Korea

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-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.

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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
Control groupExperimentalDrug: AtropineAnaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1.And receive normal saline for control group
Atropine groupActive comparatorDrug: Normal salineAnaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1. And receive atropine (atropine sulfate) 10 μg.kg-1 for atropine group.
  • Atropine (Drug), also known as Atropine sulfate: 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 (Drug): 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

+Outcome measures

Primary outcomes

  • intubation time [intubating condition at 120 seconds from rocuronium injection]: 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.

+Eligibility

Sex: All, ages: 3 Years to 10 Years

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

+Locations (1)

FacilityCityCountryStatus
Gachon University Gil Medical CenterIncheonSouth Korea

+Publications

  • 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. doi: 10.1046/j.1460-9592.1998.00719.x. PMID 9483596

+Investigators

My Notes