Pharyngitis Clinical Trial
Official title:
Evaluating Ropivacaine and Lidocaine in the Endotracheal Tube Cuff on Post-Operative Sore Throat Incidence and Severity - A Randomized Clinical Trial
Verified date | January 2019 |
Source | University of Saskatchewan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In elective gynecology and general surgery patients age 18 and over requiring endotracheal tube (ETT) intubation, what is the efficacy of ropivacaine 0.5% vs. lidocaine 2% as the medium to inflate the ETT cuff, compared to the standard of air, in reducing the incidence and severity of POST on post-op day one?
Status | Completed |
Enrollment | 63 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Elective gynecology and general surgery patients - Age 18 or older - Must be coming for a surgical procedure that requires having a general -anesthetic requiring endotracheal intubation - Must be admitted to hospital for more than one day - ASA class 1-3 inclusive Exclusion Criteria: - Pre-operative sore throat the day of of recruitment - Upper respiratory tract infection in the previous 4 weeks - Intra-operative use of transesophageal echocardiography |
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | Saskatoon City Hospital | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
Chang YW, Chou YC, Yeh CC, Hu CJ, Hung CJ, Lin CS, Chen TL, Liao CC. Outcomes after major surgery in patients with myasthenia gravis: A nationwide matched cohort study. PLoS One. 2017 Jun 30;12(6):e0180433. doi: 10.1371/journal.pone.0180433. eCollection 2017. — View Citation
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-404. doi: 10.1016/j.pain.2011.07.005. — View Citation
Kumar RD, Hirsch NP. Clinical evaluation of stethoscope-guided inflation of tracheal tube cuffs. Anaesthesia. 2011 Nov;66(11):1012-6. doi: 10.1111/j.1365-2044.2011.06853.x. Epub 2011 Aug 18. — View Citation
Lam F, Lin YC, Tsai HC, Chen TL, Tam KW, Chen CY. Effect of Intracuff Lidocaine on Postoperative Sore Throat and the Emergence Phenomenon: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Aug 19;10(8):e0136184. doi: 10.1371/journal.pone.0136184. eCollection 2015. Review. — View Citation
Navarro RM, Baughman VL. Lidocaine in the endotracheal tube cuff reduces postoperative sore throat. J Clin Anesth. 1997 Aug;9(5):394-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative sore throat | Using Numerical Rating Scale of 0-10 | Post-operative day one | |
Secondary | Incidence of cough at extubation | Mild (<5 coughs), moderate (5-10 coughs), or severe (>10 coughs) | From time of surgery closure plus one hour | |
Secondary | Post-operative sore throat | Using Numerical Rating Scale of 0-10 | Prior to leaving post anesthetic care unit plus two hours | |
Secondary | Time spent in post anesthetic care unit (PACU) | From time entered PACU until criteria met to be discharged from PACU | Surgical day zero | |
Secondary | Dysphagia | Incidence of dysphagia (defined as difficulty in swallowing) | Once criteria met to be discharged from the post anesthetic care unit plus two hours, and on post operative day one up to 36 hours post-op | |
Secondary | Patient satisfaction | Using a 5-point Likert scale with the following categories: very satisfied, satisfied, neither, dissatisfied, or very dissatisfied | Post-operative day one | |
Secondary | Surgical site pain score | Using Numerical Rating Scale of 0-10 | Once criteria met to be discharged from the post anesthetic care unit plus two hours, and and on post operative day one up to 36 hours post-op | |
Secondary | Dysphonia | Incidence of dysphonia (defined as a rough or harsh voice pattern) | Once criteria met to be discharged from the post anesthetic care unit plus two hours, and and on post operative day one up to 36 hours post-op |
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