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Inhalation of Lidocaine Before Intubation

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ClinicalTrials.gov Identifier: NCT01838993
Recruitment Status : Unknown
Verified April 2013 by Chen Yen-Po, New Taipei City Hospital.
Recruitment status was:  Recruiting
First Posted : April 24, 2013
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.

Condition or disease Intervention/treatment
Sore Throat Drug: Lidocaine inhalation Drug: Placebo

Detailed Description:
Sudden increases in blood pressure and heart rate after tracheal intubation and post-operative sore throat are two common undesirable side effects of general anesthesia and might lead to patients' morbidity or dissatisfaction. We investigated the possibility to attenuate both side effects with one single method, i.e. ultrasound-driven lidocaine inhalation immediately before induction.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Ultrasonic Nebulizer Delivered Lidocaine on Circulatory Responses During Tracheal Intubation and Postoperative Sore Throat
Study Start Date : January 2013
Estimated Primary Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Lidocaine
Inhalation of lidocaine before intubation
Drug: Lidocaine inhalation
Lidocaine inhalation before intubation
Placebo Comparator: Control
Normal saline inhalation before intubation
Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 3 min ]
    Non invasive blood pressure every min for 3 min


Secondary Outcome Measures :
  1. Post operative sore throat [ Time Frame: 3 days ]
    Questionnaire for Post operative sore throat


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I or II. Patients scheduled for elective surgery under general anesthesia with orotracheal intubation

Exclusion Criteria:

  • patient's refusal to join, major surgery or expected operation duration longer than 3 hours, patients with a anticipated difficult airway, requiring a nasogastric tube in peri-operative stage, having recent upper respiratory tract infection (within 1 week) or pre-existing sore throat.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838993


Contacts
Contact: Chen Yen Po, MD drbrianchan@yahoo.com.tw

Locations
Taiwan
New Taipei City Hospital Recruiting
New Taipei City, Taiwan
Contact: Lin Chi-Hsuan, MD       ad2354@ntpc.gov.tw   
Sponsors and Collaborators
New Taipei City Hospital
Investigators
Principal Investigator: Chen Yen Po, MD New Taipei City Hospital
More Information

Responsible Party: Chen Yen-Po, Physician, New Taipei City Hospital
ClinicalTrials.gov Identifier: NCT01838993     History of Changes
Other Study ID Numbers: CS 2013011
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Chen Yen-Po, New Taipei City Hospital:
anesthetics,
local,
lidocaine;
nebulizers and vaporizers;
complications,
intubation,
intratracheal.

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action