Intubation Time With Low Dose Rocuronium

NCT01464489 | Completed DMC

• 1 other identifier: AJIRB-MED-CT4-11-074
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation; Difficult

Keywords

Intubation time; Atropine; Propofol anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

EXPERIMENTAL

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

Drug: Atropine

Atropine group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Atropine sulfate

Control group

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

Atropine group

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I,
• Tonsillectomy with adenoidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

Gachon University Gil Medical Center

Incheon, South Korea

Location

Related 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. doi: 10.1046/j.1460-9592.1998.00719.x.

  PMID: 9483596 BACKGROUND

MeSH Terms

Interventions

Atropine; Saline Solution

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jong Yeop Kim, MD,PhD

  Ajou University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 3, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 3, 2011

Record last verified: 2011-11

Locations

KR (1)