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Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774292
First Posted: January 23, 2013
Last Update Posted: October 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanick Sansoucy, Université de Sherbrooke
  Purpose
The purpose of the study is to determined whether the administration of alkalized 4% lidocaine (160 mg) in the endotracheal tube cuff is effective in diminishing the incidence of coughing at extubation in surgeries lasting more than 2 hours without the use of nitrous oxide as an anesthetic agent.

Condition Intervention Phase
Coughing Extubation Lidocaine Endotracheal Cuff Procedure: Endotracheal intubation with injection of liquid in the cuff Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation in Surgeries Without Nitrous Oxide Lasting More Than 2 Hours

Resource links provided by NLM:


Further study details as provided by Yanick Sansoucy, Université de Sherbrooke:

Primary Outcome Measures:
  • Coughing [ Time Frame: 24 hours after the end ofsurgery ]

Secondary Outcome Measures:
  • Throat pain [ Time Frame: 24 hours after the end of surgery ]
  • Nausea and Vomiting [ Time Frame: 24 hours after end of surgery ]
  • Hoarseness of the voice [ Time Frame: 24 hours after end of surgery ]

Enrollment: 80
Study Start Date: January 2013
Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alkalized lidocaine
160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.
Procedure: Endotracheal intubation with injection of liquid in the cuff
Placebo Comparator: Sterile saline
4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.
Procedure: Endotracheal intubation with injection of liquid in the cuff

Detailed Description:
The diffusion of nitrous oxide inside the endotracheal cuff leads to increase pressure, pain and coughing. Studies have shown benefit of alkalized lidocaine and other mediums within the cuff with nitrous oxide. No study has yet evaluated the benefit of alkalized lidocaine in long surgeries without the use of nitrous oxide.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- ASA 1,2 or 3 patients requiring general anesthesia for an elective urological or gynecological surgery predicted to last more than 2 hours

Exclusion Criteria:

  • Patient refusal
  • Lidocaine allergy
  • Any allergies to drugs or anesthetics used during the study
  • Under 18 years of age
  • Pregnant
  • Previous airway surgery
  • Cormack 3 or 4 or anticipated difficult airway
  • Upper respiratory tract infection in the last month
  • Active respiratory disease
  • Chronic cough or throat pain
  • Gastro-esophageal reflux disease or at risk for aspiration
  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): NCT01774292


Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Yanick Sansoucy, Doctor Université de Sherbrooke
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanick Sansoucy, Anesthesiologist, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01774292     History of Changes
Other Study ID Numbers: 12182
First Submitted: January 4, 2013
First Posted: January 23, 2013
Last Update Posted: October 30, 2015
Last Verified: October 2015

Keywords provided by Yanick Sansoucy, Université de Sherbrooke:
Impact of alkalized lidocaine on coughing at extubation

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
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