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

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

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%).

Study Overview

• Status: Unknown
• Conditions: Postoperative Sore Throat; Postoperative Cough
• Intervention / Treatment: Other: cuff inflation with air; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia; Drug: cuff inflation with lidocaine 1%; Drug: cuff inflation with 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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Ogarite Habib
• Investigators: Study Director: Hicham Jabbour, MD, Saint JU

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: December 22, 2018
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Endotracheal intubation; General anesthesia; Postoperative sore throat; Postoperative cough; Lidocaine 2%; Lidocaine 1%; Endotracheal tube cuff; Cuff inflation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Cough; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine
• Other Study ID Numbers: CEHDF 1263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No