Clinical trial NCT01715688: Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff on the Incidence of Coughing During Emergence
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Anesthesia
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
First posted: 2012-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of coughing during emergence of general anesthesia
timeFrame: At extubation (Day 0)
Secondary outcomes:
measure: Time to emergence
timeFrame: At extubation (Day 0)
measure: Incidence of sore throat
timeFrame: One hour after extubation (Day 0)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Université de Monrtréal
name: Nathalie Massicotte, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.