Intubation Time With Low Dose Rocuronium
This study has been completed.
Information provided by (Responsible Party):
Youn Yi Jo, Gachon University Gil Medical Center
First received: October 18, 2011
Last updated: November 1, 2011
Last verified: November 2011
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.
Drug: Normal saline
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
||Study of Intubation Time Required for Excellent Tracheal Intubation With Low Dose Rocuronium During Propofol Anaesthesia in Children With and Without Atropine
Primary Outcome Measures:
- intubation time [ Time Frame: intubating condition at 120 seconds from rocuronium injection ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
Experimental: 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
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 Name: Atropine sulfate
Active Comparator: 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.
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
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.
|Ages Eligible for Study:
||3 Years to 10 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- American Society of Anesthesiologists (ASA) physical status I,
- Tonsillectomy with adenoidectomy
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01464489
|Gachon University Gil Medical Center
|Incheon, Korea, Republic of |
Gachon University Gil Medical Center
||Jong Yeop Kim, MD,PhD
||Ajou University School of Medicine
||Youn Yi Jo, assistant professor, Gachon University Gil Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 18, 2011
||November 1, 2011
||United States: Institutional Review Board
Korea: Institutional Review Board
Keywords provided by Gachon University Gil Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 04, 2016
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neuromuscular Blocking Agents
Neuromuscular Nondepolarizing Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents