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
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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
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 |
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