NCT01489683

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

December 7, 2011

Last Update Submit

July 13, 2012

Conditions

Keywords

intubating conditionspropofolremifentaniltopical lidocaine

Outcome Measures

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.

    baseline from 5 min of TCI was maintained

Study Arms (2)

control

EXPERIMENTAL

3 ml of normal saline was instilled to larynx and trachea

Drug: lidocaine

lidocaine

ACTIVE COMPARATOR

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

Drug: normal saline

Interventions

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

Also known as: 4%lidocaine
control

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

Also known as: control
lidocaine

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, 443-721, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 8836274BACKGROUND

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jong Yeop Kim, MD

    Ajou University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 12, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations