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Clinical Trials/NCT03792776
NCT03792776
Unknown
Not Applicable

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

Ogarite Habib0 sites150 target enrollmentJanuary 2019

Overview

Phase
Not Applicable
Intervention
cuff inflation with air
Conditions
Postoperative Sore Throat
Sponsor
Ogarite Habib
Enrollment
150
Primary Endpoint
Sore throat intensity 2
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2019
End Date
October 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ogarite Habib
Responsible Party
Sponsor Investigator
Principal Investigator

Ogarite Habib

Principal Investigator

Saint-Joseph University

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
  • Cognitive disorders
  • Swallowing disorders
  • Corticotherapy during the last week
  • Allergy to lidocaine
  • Urgent surgery
  • Nasogastric, oro-gastric

Arms & Interventions

Air

Endotracheal tube cuff inflation with air

Intervention: cuff inflation with air

Air

Endotracheal tube cuff inflation with air

Intervention: Induction of anesthesia

Air

Endotracheal tube cuff inflation with air

Intervention: Maintenance of anesthesia

Air

Endotracheal tube cuff inflation with air

Intervention: Endotracheal intubation

Air

Endotracheal tube cuff inflation with air

Intervention: Systematic post-operative analgesia

Lidocaine 1%

Endotracheal tube cuff inflation with Lidocaine 1%

Intervention: cuff inflation with lidocaine 1%

Lidocaine 1%

Endotracheal tube cuff inflation with Lidocaine 1%

Intervention: Induction of anesthesia

Lidocaine 1%

Endotracheal tube cuff inflation with Lidocaine 1%

Intervention: Maintenance of anesthesia

Lidocaine 1%

Endotracheal tube cuff inflation with Lidocaine 1%

Intervention: Endotracheal intubation

Lidocaine 1%

Endotracheal tube cuff inflation with Lidocaine 1%

Intervention: Systematic post-operative analgesia

Lidocaine 2%

Endotracheal tube cuff inflation with Lidocaine 2%

Intervention: cuff inflation with lidocaine 2%

Lidocaine 2%

Endotracheal tube cuff inflation with Lidocaine 2%

Intervention: Induction of anesthesia

Lidocaine 2%

Endotracheal tube cuff inflation with Lidocaine 2%

Intervention: Maintenance of anesthesia

Lidocaine 2%

Endotracheal tube cuff inflation with Lidocaine 2%

Intervention: Endotracheal intubation

Lidocaine 2%

Endotracheal tube cuff inflation with Lidocaine 2%

Intervention: Systematic post-operative analgesia

Outcomes

Primary Outcomes

Sore throat intensity 2

Time Frame: at 2 hours after extubation

Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))

Cough intensity 2

Time Frame: at 2 hours after extubation

Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))

Cough intensity 6

Time Frame: at 6 hours after extubation

Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))

Cough intensity 24

Time Frame: at 24 hours after extubation

Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))

Cough intensity 0

Time Frame: hour 0 after extubation

Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))

Sore throat intensity 0

Time Frame: hour 0 after extubation

Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))

Sore throat intensity 24

Time Frame: at 24 hours after extubation

Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))

Sore throat intensity 6

Time Frame: at 6 hours after extubation

Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))

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