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

NCT ID: NCT01715688

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-04-30

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.

Conditions

Cough; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Alkalinized lidocaine

Intervention Type: DRUG

Administration of alkalinized lidocaine in the endotracheal tube cuff

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Administration of saline in the endotracheal tube cuff

Interventions

Alkalinized lidocaine

Administration of alkalinized lidocaine in the endotracheal tube cuff

Intervention Type: DRUG

Saline

Administration of saline in the endotracheal tube cuff

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie Massicotte, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Université de Monrtréal

Locations

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29189279 (View on PubMed)

Other Identifiers

NM2012-003

Identifier Type: -

Identifier Source: org_study_id