Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

This study is not yet open for participant recruitment.

Verified January 2013 by Universitaire de Sherbrooke

Sponsor:

Information provided by (Responsible Party):

Yanick Sansoucy, Universitaire de Sherbrooke

ClinicalTrials.gov Identifier:

NCT01774292

First received: January 4, 2013

Last updated: January 19, 2013

Last verified: January 2013

History of Changes

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:

MedlinePlus related topics: Cough Nausea and Vomiting

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by Universitaire 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

Universitaire de Sherbrooke

Investigators

Principal Investigator:

Yanick Sansoucy, Doctor

Universitaire de Sherbrooke

More Information

Publications:

Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, Ecoffey C. Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004 Mar;92(3):361-6.

Estebe JP, Gentili M, Le Corre P, Dollo G, Chevanne F, Ecoffey C. Alkalinization of intracuff lidocaine: efficacy and safety. Anesth Analg. 2005 Nov;101(5):1536-41.

Estebe JP, Dollo G, Le Corre P, Le Naoures A, Chevanne F, Le Verge R, Ecoffey C. Alkalinization of intracuff lidocaine improves endotracheal tube-induced emergence phenomena. Anesth Analg. 2002 Jan;94(1):227-30, table of contents.

Navarro LH, Lima RM, Aguiar AS, Braz JR, Carness JM, Módolo NS. The effect of intracuff alkalinized 2% lidocaine on emergence coughing, sore throat, and hoarseness in smokers. Rev Assoc Med Bras. 2012 Apr;58(2):248-53.

Responsible Party:	Yanick Sansoucy, Anesthesiologist, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:	NCT01774292 History of Changes
Other Study ID Numbers:	12182
Study First Received:	January 4, 2013
Last Updated:	January 19, 2013
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by Universitaire 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 June 17, 2013

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