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Completed

NCT Number: NCT01464489

Intubation Time With Low Dose Rocuronium

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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Key information

Conditions

Intubation; Difficult

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gachon University Gil Medical Center

Incheon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine

Drug

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

Other names: Atropine sulfate

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

Primary outcomes

  1. intubation time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2011
Registry last updated
Nov 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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