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

Postoperative Sore Throat Clinical Trial

— ELIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03792776
• Other study ID #: CEHDF 1263
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Est. completion date: October 2020

Study information

• Verified date: January 2019
• Source: Saint-Joseph University
• Contact: Ogarite P Habib, MD
• Phone: +9613722518
• Email: Ogarite.habib[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cough
• Pharyngitis
• Postoperative Cough
• Postoperative Sore Throat

Intervention

Other:
• cuff inflation with air
Endotracheal tube cuff inflation with air

Drug:
• cuff inflation with lidocaine 1%
Endotracheal tube cuff inflation with lidocaine 1%
• cuff inflation with 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.
• 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).
• 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).
• Systematic post-operative analgesia
All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ogarite Habib

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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