Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 30, 2014
Last verified: May 2014
  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 after the end ofsurgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Throat pain [ Time Frame: 24 hours after the end of surgery ] [ Designated as safety issue: No ]
  • Nausea and Vomiting [ Time Frame: 24 hours after end of surgery ] [ Designated as safety issue: No ]
  • Hoarseness of the voice [ Time Frame: 24 hours after end of surgery ] [ 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
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: 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: May 30, 2014
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
Signs and Symptoms, Respiratory
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
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 October 22, 2014