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Intubation Time With Low Dose Rocuronium

NCT ID: NCT01464489

Last Updated: 2011-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intubation; Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control group

Anaesthesia 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

Group Type EXPERIMENTAL

Atropine

Intervention Type 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

Atropine group

Anaesthesia 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.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Atropine sulfate

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Youn Yi Jo

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Yeop Kim, MD,PhD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 9483596 (View on PubMed)

Other Identifiers

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AJIRB-MED-CT4-11-074

Identifier Type: -

Identifier Source: org_study_id