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Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

Primary Purpose

Coughing, Extubation, Lidocaine

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Endotracheal intubation with injection of liquid in the cuff
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coughing focused on measuring Impact of alkalized lidocaine on coughing at extubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de Sherbrooke

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alkalized lidocaine

Sterile saline

Arm Description

160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

Outcomes

Primary Outcome Measures

Coughing

Secondary Outcome Measures

Throat pain
Nausea and Vomiting
Hoarseness of the voice

Full Information

First Posted
January 4, 2013
Last Updated
October 29, 2015
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT01774292
Brief Title
Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coughing, Extubation, Lidocaine, Endotracheal Cuff
Keywords
Impact of alkalized lidocaine on coughing at extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alkalized lidocaine
Arm Type
Active Comparator
Arm Description
160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.
Arm Title
Sterile saline
Arm Type
Placebo Comparator
Arm Description
4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.
Intervention Type
Procedure
Intervention Name(s)
Endotracheal intubation with injection of liquid in the cuff
Primary Outcome Measure Information:
Title
Coughing
Time Frame
24 hours after the end ofsurgery
Secondary Outcome Measure Information:
Title
Throat pain
Time Frame
24 hours after the end of surgery
Title
Nausea and Vomiting
Time Frame
24 hours after end of surgery
Title
Hoarseness of the voice
Time Frame
24 hours after end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanick Sansoucy, Doctor
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
14970135
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. doi: 10.1093/bja/aeh078.
Results Reference
background
PubMed Identifier
16244028
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):1536-1541. doi: 10.1213/01.ANE.0000180995.24211.89.
Results Reference
background
PubMed Identifier
11772834
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. doi: 10.1097/00000539-200201000-00044.
Results Reference
background
PubMed Identifier
11384855
Citation
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. doi: 10.1016/s0928-0987(01)00119-1.
Results Reference
background
PubMed Identifier
22569622
Citation
Navarro LH, Lima RM, Aguiar AS, Braz JR, Carness JM, Modolo NS. The effect of intracuff alkalinized 2% lidocaine on emergence coughing, sore throat, and hoarseness in smokers. Rev Assoc Med Bras (1992). 2012 Mar-Apr;58(2):248-53.
Results Reference
background
PubMed Identifier
27075030
Citation
Souissi H, Frechette Y, Murza A, Masse MH, Marsault E, Sarret P, D'Aragon F, Parent AJ, Sansoucy Y. Intracuff 160 mg alkalinized lidocaine reduces cough upon emergence from N2O-free general anesthesia: a randomized controlled trial. Can J Anaesth. 2016 Jul;63(7):862-70. doi: 10.1007/s12630-016-0652-8. Epub 2016 Apr 13.
Results Reference
derived

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Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

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