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

NCT03792776 | Unknown

• 1 other identifier: CEHDF 1263
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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%).

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

Air

ACTIVE COMPARATOR

Endotracheal tube cuff inflation with air

Other: cuff inflation with air; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia

Lidocaine 1%

EXPERIMENTAL

Endotracheal tube cuff inflation with Lidocaine 1%

Drug: cuff inflation with lidocaine 1%; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia

Lidocaine 2%

EXPERIMENTAL

Endotracheal tube cuff inflation with Lidocaine 2%

Drug: cuff inflation with lidocaine 2%; Other: Induction of anesthesia; Other: Maintenance of anesthesia; Other: Endotracheal intubation; Other: Systematic post-operative analgesia

Interventions

cuff inflation with air OTHER

Endotracheal tube cuff inflation with air

Air

cuff inflation with lidocaine 1% DRUG

Endotracheal tube cuff inflation with lidocaine 1%

Lidocaine 1%

cuff inflation with lidocaine 2% DRUG

Endotracheal tube cuff inflation with lidocaine 2%

Lidocaine 2%

Induction of anesthesia OTHER

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.

Air; Lidocaine 1%; Lidocaine 2%

Maintenance of anesthesia OTHER

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).

Air; Lidocaine 1%; Lidocaine 2%

Endotracheal intubation OTHER

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).

Air; Lidocaine 1%; Lidocaine 2%

Systematic post-operative analgesia OTHER

All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.

Air; Lidocaine 1%; Lidocaine 2%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• American Society of Anesthesiologists classification (ASA) category 1 or 2
• High pressure, low volume endotracheal tube - (Lo-pro)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ogarite Habib: lead

MeSH Terms

Interventions

Air; Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Hicham Jabbour, MD

  Saint JU

  STUDY DIRECTOR

Central Study Contacts

Ogarite P Habib, MD

CONTACT

+9613722518; Ogarite.habib@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2018
• First Posted: January 3, 2019
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2020
• Last Updated: January 15, 2019

Record last verified: 2019-01