Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Yeop Kim, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01489683
First received: December 7, 2011
Last updated: July 13, 2012
Last verified: July 2012

December 7, 2011
July 13, 2012
May 2011
April 2012   (final data collection date for primary outcome measure)
Overall acceptable conditions for tracheal intubation [ Time Frame: baseline from 5 min of TCI was maintained ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01489683 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine
Effect of Tracheal Lidocaine on Intubating Conditions During Propofol-remifentanil TCI Without Neuromuscular Blockade

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Drug Usage
  • Drug: lidocaine
    3 ml of 4% lidocaine was instilled to larynx and trachea
    Other Name: 4%lidocaine
  • Drug: normal saline
    3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation
    Other Name: control
  • Experimental: control
    3 ml of normal saline was instilled to larynx and trachea
    Intervention: Drug: lidocaine
  • Active Comparator: lidocaine
    3 ml of 4% lidocaine was instilled to larynx and trachea before endotracheal intubation
    Intervention: Drug: normal saline
Bülow 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • bronchial asthma,
  • COPD,
  • hypertension,
  • anticipated difficult airway
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01489683
AJIRB-MED-CT4-11-073
No
Jong Yeop Kim, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Study Director: Jong Yeop Kim, MD Ajou University School of Medicine
Ajou University School of Medicine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP