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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cough; Anesthesia
• Intervention / Treatment: Drug: Alkalinized lidocaine; Drug: Saline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alkalinized lidocaine; 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; Administration of alkalinized lidocaine in the endotracheal tube cuff
Placebo Comparator: Saline; 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; Administration of saline in the endotracheal tube cuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of coughing during emergence of general anesthesia	At extubation (Day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to emergence	At extubation (Day 0)
Incidence of sore throat	One hour after extubation (Day 0)

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
• Investigators: Principal Investigator: Nathalie Massicotte, MD, FRCPC, Centre Hospitalier de l'Université de Monrtréal

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: NM2012-003