Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

This study is currently recruiting participants.
Verified December 2013 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Yanick Sansoucy, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01774292
First received: January 4, 2013
Last updated: December 5, 2013
Last verified: December 2013
  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: Double Blind (Subject, Caregiver, 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 Université de Sherbrooke:

Primary Outcome Measures:
  • Coughing [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Throat pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Nausea and Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Hoarseness of the voice [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774292

Contacts
Contact: Marie-Hélène Masse, RRT 819-346-1110 ext 14953 mhmasse.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Sub-Investigator: Yannick Frechette, Doctor         
Sub-Investigator: Houssine Souissi, Doctor         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Yanick Sansoucy, Doctor Université de Sherbrooke
  More Information

Publications:
Responsible Party: Yanick Sansoucy, Anesthesiologist, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01774292     History of Changes
Other Study ID Numbers: 12182
Study First Received: January 4, 2013
Last Updated: December 5, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014