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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
  Purpose

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.


Condition Intervention
Drug Usage
Drug: lidocaine
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Tracheal Lidocaine on Intubating Conditions During Propofol-remifentanil TCI Without Neuromuscular Blockade

Resource links provided by NLM:


Further study details as provided by Ajou University School of Medicine:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: control
3 ml of normal saline was instilled to larynx and trachea
Drug: lidocaine
3 ml of 4% lidocaine was instilled to larynx and trachea
Other Name: 4%lidocaine
Active Comparator: lidocaine
3 ml of 4% lidocaine was instilled to larynx and trachea before endotracheal intubation
Drug: normal saline
3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation
Other Name: control

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • bronchial asthma,
  • COPD,
  • hypertension,
  • anticipated difficult airway
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01489683

Locations
Korea, Republic of
Ajou University School of Medicine
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Study Director: Jong Yeop Kim, MD Ajou University School of Medicine
  More Information

Publications:
Responsible Party: Jong Yeop Kim, Associate professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01489683     History of Changes
Other Study ID Numbers: AJIRB-MED-CT4-11-073
Study First Received: December 7, 2011
Last Updated: July 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Ajou University School of Medicine:
intubating conditions
propofol
remifentanil
topical lidocaine

Additional relevant MeSH terms:
Lidocaine
Propofol
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014