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

Not Applicable

• Conditions: Postoperative Cough; Postoperative Sore Throat
• Interventions: Other: cuff inflation with air; Drug: cuff inflation with lidocaine 1%; Drug: cuff inflation with lidocaine 2%; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia

• Registration Number: NCT03792776
• Lead Sponsor: Ogarite Habib

Brief Summary

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%).

Detailed 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.

Study Timeline

• Study First Submitted: 2018-12-22
• Status Verified: 2019-01
• Study Start: 2019-01
• Study First Submitted QC: 2019-01-01
• Study First Posted: 2019-01-03
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15
• Primary Completion: 2019-04
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air	cuff inflation with air	Endotracheal tube cuff inflation with air
Lidocaine 2%	Systematic post-operative analgesia	Endotracheal tube cuff inflation with Lidocaine 2%
Air	Induction of anesthesia	Endotracheal tube cuff inflation with air
Air	Systematic post-operative analgesia	Endotracheal tube cuff inflation with air
Lidocaine 1%	cuff inflation with lidocaine 1%	Endotracheal tube cuff inflation with Lidocaine 1%
Lidocaine 2%	cuff inflation with lidocaine 2%	Endotracheal tube cuff inflation with Lidocaine 2%
Lidocaine 2%	Maintenance of anesthesia	Endotracheal tube cuff inflation with Lidocaine 2%
Lidocaine 1%	Maintenance of anesthesia	Endotracheal tube cuff inflation with Lidocaine 1%
Lidocaine 1%	Endotracheal intubation	Endotracheal tube cuff inflation with Lidocaine 1%
Lidocaine 1%	Systematic post-operative analgesia	Endotracheal tube cuff inflation with Lidocaine 1%
Air	Endotracheal intubation	Endotracheal tube cuff inflation with air
Lidocaine 1%	Induction of anesthesia	Endotracheal tube cuff inflation with Lidocaine 1%
Lidocaine 2%	Induction of anesthesia	Endotracheal tube cuff inflation with Lidocaine 2%
Air	Maintenance of anesthesia	Endotracheal tube cuff inflation with air
Lidocaine 2%	Endotracheal intubation	Endotracheal tube cuff inflation with Lidocaine 2%

Primary Outcome Measures

Name	Time	Method
Sore throat intensity 2	at 2 hours after extubation	Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Cough intensity 2	at 2 hours after extubation	Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 6	at 6 hours after extubation	Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 24	at 24 hours after extubation	Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 0	hour 0 after extubation	Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Sore throat intensity 0	hour 0 after extubation	Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 24	at 24 hours after extubation	Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 6	at 6 hours after extubation	Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))