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Completed

NCT Number: NCT01774292

Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

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.

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Key information

Conditions

Coughing Cough Endotracheal Cuff Extubation Lidocaine Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal intubation with injection of liquid in the cuff

Procedure

Primary outcomes

  1. Coughing

    Time frame: 24 hours after the end ofsurgery

Secondary outcomes

  1. Throat pain

    Time frame: 24 hours after the end of surgery

  2. Nausea and Vomiting

    Time frame: 24 hours after end of surgery

  3. Hoarseness of the voice

    Time frame: 24 hours after end of surgery

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Evaluation of the Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation in Surgeries Without Nitrous Oxide Lasting More Than 2 Hours

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2013
Registry last updated
Oct 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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