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Completed

NCT Number: NCT01715688

Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff on the Incidence of Coughing During Emergence

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.

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Key information

Conditions

Cough Anesthesia 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

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

About this study

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.

Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. Intracuff lidocaine has been shown to increase the tolerance to the endotracheal tube without reducing the swallowing reflex. However, lidocaine slowly diffuses across the tube's cuff. The addition of bicarbonates is required to increase its diffusion to the underlying tracheal tissue. Alkalinization of lidocaine allows the diffusion of 65% of its neutral base form over a period of 6 hours.

In vitro studies have demonstrated that the optimal time for local anesthetic diffusion through the cuff may vary from 90 to 180 minutes. Due to its low onset, this technique would be appropriate for long-duration surgeries. Pre-filling the endotracheal tube cuffs with alkalinized lidocaine at least 90 minutes before intubation could be appropriate for surgeries expected to last less than two hours.

This study will assess the efficacy of pre-filling endotracheal tube cuffs with alkalinized lidocaine to prevent coughing during emergence in short-duration surgeries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Alkalinized lidocaine

Drug

Administration of alkalinized lidocaine in the endotracheal tube cuff

Saline

Drug

Administration of saline in the endotracheal tube cuff

Primary outcomes

  1. Incidence of coughing during emergence of general anesthesia

    Time frame: At extubation (Day 0)

Secondary outcomes

  1. Time to emergence

    Time frame: At extubation (Day 0)

  2. Incidence of sore throat

    Time frame: One hour after extubation (Day 0)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Registry information

Official study title

Efficacy of Endotracheal Tube Cuffs Pre-filled With Alkalinized Lidocaine Compared to Endotracheal Tube Cuffs Filled With Saline on the Incidence of Coughing During Emergence of Anesthesia.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2012
Registry last updated
Feb 1, 2016

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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