Inhalation of Lidocaine Before Intubation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by New Taipei City Hospital
Sponsor:
Information provided by (Responsible Party):
Chen Yen-Po, New Taipei City Hospital
ClinicalTrials.gov Identifier:
NCT01838993
First received: April 21, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

We investigate the potential benefits of ultrasound-driven lidocaine inhalation immediately before induction.


Condition Intervention
Sore Throat
Drug: Lidocaine inhalation
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by New Taipei City Hospital:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 3 min ] [ Designated as safety issue: No ]
    Non invasive blood pressure every min for 3 min


Secondary Outcome Measures:
  • Post operative sore throat [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Questionnaire for Post operative sore throat


Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chen Yen-Po, Physician, New Taipei City Hospital
ClinicalTrials.gov Identifier: NCT01838993     History of Changes
Other Study ID Numbers: CS 2013011
Study First Received: April 21, 2013
Last Updated: April 23, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014