Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough (ELIT)

Ogarite Habib

Status: Unknown

Conditions: Postoperative Cough; Postoperative Sore Throat

Treatments: Drug: cuff inflation with lidocaine 2%; Other: cuff inflation with air; Other: Systematic post-operative analgesia; Other: Maintenance of anesthesia; Drug: cuff inflation with lidocaine 1%; Other: Induction of anesthesia; Other: Endotracheal intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT03792776

CEHDF 1263

Details and patient eligibility

About

Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).

Full description

Eligible patients undergoing general anesthesia will be randomized and assigned to three groups:

Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%

The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.

Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).

The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).

The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon.

All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old
• American Society of Anesthesiologists classification (ASA) category 1 or 2
• High pressure, low volume endotracheal tube - (Lo-pro)

Exclusion criteria

• Ear nose and throat and cranial surgery
• Ear nose and throat pathologies
• Asthma and bronchial hyperreactivity
• Chronic cough
• Diabetes
• Cognitive disorders
• Swallowing disorders
• Corticotherapy during the last week
• Allergy to lidocaine
• Urgent surgery
• Nasogastric, oro-gastric
• Ventral position
• More than 2 intubation attempts
• Continuous intravenous infusion of lidocaine intraoperatively.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Air

Active Comparator group

Description:

Endotracheal tube cuff inflation with air

Treatment:

Other: cuff inflation with air

Other: Systematic post-operative analgesia

Other: Endotracheal intubation

Other: Maintenance of anesthesia

Other: Induction of anesthesia

Lidocaine 1%

Experimental group

Description:

Endotracheal tube cuff inflation with Lidocaine 1%

Treatment:

Other: Systematic post-operative analgesia

Drug: cuff inflation with lidocaine 1%

Other: Endotracheal intubation

Other: Maintenance of anesthesia

Other: Induction of anesthesia

Lidocaine 2%

Experimental group

Description:

Endotracheal tube cuff inflation with Lidocaine 2%

Treatment:

Other: Systematic post-operative analgesia

Other: Endotracheal intubation

Other: Maintenance of anesthesia

Other: Induction of anesthesia

Drug: cuff inflation with lidocaine 2%