NCT01715688

Brief Summary

This study is designed to compare the efficacy of endotracheal tube cuffs pre-filled with alkalinized lidocaine on the:

  • incidence of coughing during emergence of general anesthesia
  • time needed for emergence following a desflurane-based anesthesia
  • incidence of sore throat after extubation. The investigator's hypothesis is that the use of endotracheal tube cuffs pre-filled with alkalinized lidocaine will reduce the incidence of coughing by 50% relative to a control group following a desflurane-based anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

October 25, 2012

Last Update Submit

January 28, 2016

Conditions

CoughAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of coughing during emergence of general anesthesia

    At extubation (Day 0)

Secondary Outcomes (2)

  • Time to emergence

    At extubation (Day 0)

  • Incidence of sore throat

    One hour after extubation (Day 0)

Study Arms (2)

Alkalinized lidocaine

ACTIVE COMPARATOR

The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with alkalinized lidocaine. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube). During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.

Drug: Alkalinized lidocaine

Saline

PLACEBO COMPARATOR

The endotracheal tube cuff will be pre-filled at least 90 minutes before intubation with saline. Endotracheal tube cuff will be emptied before intubation and then re-filled with the same mixture following intubation to secure the position of the endotracheal tube. (cuff will be inflated until there is no air leak around the tube). During emergence, when the expired fraction of desflurane reaches 0.2 MAC, the patient will be asked to open his eyes every 30 seconds. Any coughing effort before 0.2 MAC will be considered as a treatment failure and the patient will be treated according to the attending anaesthesiologist.

Drug: Saline

Interventions

Alkalinized lidocaineDRUG

Administration of alkalinized lidocaine in the endotracheal tube cuff

Alkalinized lidocaine
SalineDRUG

Administration of saline in the endotracheal tube cuff

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective short-duration surgery under general anesthesia (expected duration of less than 2 hours)
  • Physical status 1-3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

  • Nath P, Williams S, Herrera Mendez LF, Massicotte N, Girard F, Ruel M. Alkalinized Lidocaine Preloaded Endotracheal Tube Cuffs Reduce Emergence Cough After Brief Surgery: A Prospective Randomized Trial. Anesth Analg. 2018 Feb;126(2):615-620. doi: 10.1213/ANE.0000000000002647.

    PMID: 29189279DERIVED

MeSH Terms

Conditions

Cough

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Nathalie Massicotte, MD, FRCPC

    Centre Hospitalier de l'Université de Monrtréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2012

First Posted

October 29, 2012

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations

CA(1)