Clinical trial NCT03792776: Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough
Official title: Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Sore Throat
Postoperative Cough
Keywords: Lidocaine 1%
Lidocaine 2%
Endotracheal tube cuff
Cuff inflation
Postoperative sore throat
Postoperative cough
General anesthesia
Endotracheal intubation
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Sore throat intensity 0
timeFrame: hour 0 after extubation
measure: Sore throat intensity 2
timeFrame: at 2 hours after extubation
measure: Sore throat intensity 6
timeFrame: at 6 hours after extubation
measure: Sore throat intensity 24
timeFrame: at 24 hours after extubation
measure: Cough intensity 0
timeFrame: hour 0 after extubation
measure: Cough intensity 2
timeFrame: at 2 hours after extubation
measure: Cough intensity 6
timeFrame: at 6 hours after extubation
measure: Cough intensity 24
timeFrame: at 24 hours after extubation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Saint JU
name: Hicham Jabbour, MD
role: STUDY_DIRECTOR
References: