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

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Sore Throat, Postoperative Cough

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Air<br>Endotracheal tube cuff inflation with air | Other: cuff inflation with air<br>* Endotracheal tube cuff inflation with air<br>Other: Induction of anesthesia<br>* 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.<br>Other: Maintenance of anesthesia<br>* 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).<br>Other: Endotracheal intubation<br>* 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).<br>Other: Systematic post-operative analgesia<br>* All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.<br>|
| Experimental: Lidocaine 1%<br>Endotracheal tube cuff inflation with Lidocaine 1% | Drug: cuff inflation with lidocaine 1%<br>* Endotracheal tube cuff inflation with lidocaine 1%<br>Other: Induction of anesthesia<br>* 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.<br>Other: Maintenance of anesthesia<br>* 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).<br>Other: Endotracheal intubation<br>* 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).<br>Other: Systematic post-operative analgesia<br>* All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.<br>|
| Experimental: Lidocaine 2%<br>Endotracheal tube cuff inflation with Lidocaine 2% | Drug: cuff inflation with lidocaine 2%<br>* Endotracheal tube cuff inflation with lidocaine 2%<br>Other: Induction of anesthesia<br>* 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.<br>Other: Maintenance of anesthesia<br>* 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).<br>Other: Endotracheal intubation<br>* 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).<br>Other: Systematic post-operative analgesia<br>* All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation