Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

Phase 4

Completed

• Conditions: Coughing; Lidocaine; Endotracheal Cuff; Extubation
• Interventions: Procedure: Endotracheal intubation with injection of liquid in the cuff

• Registration Number: NCT01774292
• Lead Sponsor: Université de Sherbrooke

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-19
• Study First Posted: 2013-01-23
• Primary Completion: 2014-06
• Study Completion: 2014-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alkalized lidocaine	Endotracheal intubation with injection of liquid in the cuff	160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.
Sterile saline	Endotracheal intubation with injection of liquid in the cuff	4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

Primary Outcome Measures

Name	Time	Method
Coughing	24 hours after the end ofsurgery

Secondary Outcome Measures

Name	Time	Method
Nausea and Vomiting	24 hours after end of surgery
Throat pain	24 hours after the end of surgery
Hoarseness of the voice	24 hours after end of surgery

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada