Ropivacaine vs Lidocaine in the Endotracheal Tube Cuff on Post-Operative Sore Throat

NCT03563963 | Completed

• 1 other identifier: Bio 18-09
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Pharyngitis; Lidocaine; Ropivacaine; Intubation, Intratracheal; Post-operative Sore Throat

Outcome Measures

Primary Outcomes (1)

• Post-operative sore throat

  Using Numerical Rating Scale of 0-10

  Post-operative day one

Secondary Outcomes (7)

• Incidence of cough at extubation

  From time of surgery closure plus one hour

• Post-operative sore throat

  Prior to leaving post anesthetic care unit plus two hours

• Time spent in post anesthetic care unit (PACU)

  Surgical day zero

• Dysphagia

  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

• Patient satisfaction

  Post-operative day one

Study Arms (3)

Lidocaine 2% in Endotracheal Tube cuff

ACTIVE COMPARATOR

Lidocaine 2% will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.

Drug: Lidocaine 2% Preservative-Free Injectable Solution

Ropivacaine 0.5% Endotracheal Tube cuff

EXPERIMENTAL

Ropivacaine 0.5% will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.

Drug: Ropivacaine 0.5% Injectable Solution

Air in the Endotracheal Tube cuff

ACTIVE COMPARATOR

Air will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.

Other: Air

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

Ropivacaine 0.5% will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.

Ropivacaine 0.5% Endotracheal Tube cuff

Lidocaine 2% Preservative-Free Injectable Solution DRUG

Lidocaine 2% will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.

Lidocaine 2% in Endotracheal Tube cuff

Air OTHER

Air will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.

Air in the Endotracheal Tube cuff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pre-operative sore throat the day of of recruitment
• Upper respiratory tract infection in the previous 4 weeks
• Intra-operative use of transesophageal echocardiography

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7n0W8, Canada

Location

Related Publications (5)

• 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.

  PMID: 28666024 BACKGROUND

• 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.

  PMID: 21851343 BACKGROUND

• Navarro RM, Baughman VL. Lidocaine in the endotracheal tube cuff reduces postoperative sore throat. J Clin Anesth. 1997 Aug;9(5):394-7. doi: 10.1016/s0952-8180(97)00068-8.

  PMID: 9257206 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• 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.

  PMID: 26288276 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Ropivacaine; Lidocaine; Air

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Jonathan Gamble, MD, FRCPC

  Department of Anesthesiology, Perioperative Medicine and Pain Management, University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesia provider will be blinded to the intervention group allocation as the two solutions are clear, however they will not be blinded if their patient is in the control group. All patients will be anesthetized when the medium is placed in the ETT, thus patients will be blinded. The primary investigator will be blinded. The resident researcher who will be the outcome assessor will also be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The two intervention groups will be: 1) lidocaine 2% in the ETT cuff and 2) ropivacaine 0.5%in the ETT cuff. The control group will be air in the ETT cuff.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 20, 2018
• Study Start: August 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: January 17, 2019

Record last verified: 2019-01

Locations

CA (2)