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CompletedNCT01489683Updated Jul 16, 2012

Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine

An interventional study of lidocaine and normal saline in Drug Usage, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-07-16.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
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Study summary

When not using neuromuscular blocking agent, even at optimal dosage, target-controlled infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on the intubating conditions for tracheal intubation during anesthesia induction of propofol and remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.

Read the detailed description

Anesthesia was induced with propofol-remifentanil TCI with the effect-site concentration of 5μg/ml and 5ng/ml, respectively. After TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, following intubation was performed.

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Conditions studied

  • Drug Usage

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Keywords

  • intubating conditions
  • propofol
  • remifentanil
  • topical lidocaine
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In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 732 interventional studies indexed under Disease.

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Lead sponsor

Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I, II patients undergoing general anesthesia for reduction of nasal bone fracture

Exclusion criteria

Exclusion Criteria:

  • bronchial asthma,
  • COPD,
  • hypertension,
  • anticipated difficult airway
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    control

    3 ml of normal saline was instilled to larynx and trachea

    Drug: lidocaine

  • Active comparator
    lidocaine

    3 ml of 4% lidocaine was instilled to larynx and trachea before endotracheal intubation

    Drug: normal saline

Interventions

  • Druglidocaine

    3 ml of 4% lidocaine was instilled to larynx and trachea

    Also known as: 4%lidocaine

  • Drugnormal saline

    3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation

    Also known as: control

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What researchers measure

Primary outcomes

  1. Overall acceptable conditions for tracheal intubation

    Four minutes after start of propofol-remifentanil TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, and one minute later, intubation was performed in double-blinded fashion.

    Time frame: baseline from 5 min of TCI was maintained

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Study locations

1 site
  • Ajou University School of Medicine
    Suwon, 443-721, Korea, Republic of
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References and documents

Publications

  • Bulow K, Nielsen TG, Lund J. The effect of topical lignocaine on intubating conditions after propofol-alfentanil induction. Acta Anaesthesiol Scand. 1996 Jul;40(6):752-6. doi: 10.1111/j.1399-6576.1996.tb04523.x. PubMed 8836274 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01489683
Lead sponsor
Ajou University School of Medicine
Responsible party
Jong Yeop Kim (Associate professor, Ajou University School of Medicine) — Principal investigator
First posted
Dec 12, 2011
Start date
May 2011
Primary completion
Apr 2012
Completion
May 2012
Last update
Jul 16, 2012

Study contacts

Jong Yeop Kim, MD
study director · Ajou University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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