Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

Lidocaine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774292
• Other study ID #: 12182
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2013
• Last updated: October 29, 2015
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cough
• Coughing
• Endotracheal Cuff
• Extubation
• Lidocaine

Intervention

Procedure:
• Endotracheal intubation with injection of liquid in the cuff

Locations

Country	Name	City	State
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Dollo G, Estebe JP, Le Corre P, Chevanne F, Ecoffey C, Le Verge R. Endotracheal tube cuffs filled with lidocaine as a drug delivery system: in vitro and in vivo investigations. Eur J Pharm Sci. 2001 Jun;13(3):319-23. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Mar-Apr;58(2):248-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coughing		24 hours after the end ofsurgery	No
Secondary	Throat pain		24 hours after the end of surgery	No
Secondary	Nausea and Vomiting		24 hours after end of surgery	No
Secondary	Hoarseness of the voice		24 hours after end of surgery	No