Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation

Université de Sherbrooke

Status and phase: Completed; Phase 4

Conditions: Coughing; Endotracheal Cuff; Lidocaine; Extubation

Treatments: Procedure: Endotracheal intubation with injection of liquid in the cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT01774292

12182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Alkalized lidocaine

Active Comparator group

Description:

160 mg of 4% lidocaine (4 ml) in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

Treatment:

Procedure: Endotracheal intubation with injection of liquid in the cuff

Sterile saline

Placebo Comparator group

Description:

4 mL of sterile saline in the endotracheal cuff and add bicarbonate 8,4% until appropriate seal.

Treatment:

Procedure: Endotracheal intubation with injection of liquid in the cuff