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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 February 2016
Main ID:  NCT01715688
Date of registration: 25/10/2012
Prospective Registration: Yes
Primary sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Public title: Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff on the Incidence of Coughing During Emergence
Scientific title: Efficacy of Endotracheal Tube Cuffs Pre-filled With Alkalinized Lidocaine Compared to Endotracheal Tube Cuffs Filled With Saline on the Incidence of Coughing During Emergence of Anesthesia.
Date of first enrolment: January 2013
Target sample size: 200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01715688
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Nathalie Massicotte, MD, FRCPC
Address: 
Telephone:
Email:
Affiliation:  Centre Hospitalier de l'Université de Monrtréal
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients undergoing elective short-duration surgery under general anesthesia
(expected duration of less than 2 hours)

- Physical status 1-3

Exclusion Criteria:

- Asthma or severe pulmonary disease

- Pulmonary tract infection

- Anticipated difficult intubation

- Current use of cough medicine

- Contraindication to lidocaine

- Pregnancy

- Airway surgery

- Inability to provide informed consent

- Patient refusal



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Anesthesia
Cough
Intervention(s)
Drug: Saline
Drug: Alkalinized lidocaine
Primary Outcome(s)
Incidence of coughing during emergence of general anesthesia [Time Frame: At extubation (Day 0)]
Secondary Outcome(s)
Incidence of sore throat [Time Frame: One hour after extubation (Day 0)]
Time to emergence [Time Frame: At extubation (Day 0)]
Secondary ID(s)
NM2012-003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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