Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough
NCT ID: NCT03792776
Last Updated: 2019-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2019-01-31
2020-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Air
Endotracheal tube cuff inflation with air
cuff inflation with air
Endotracheal tube cuff inflation with air
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.
Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 1%
cuff inflation with lidocaine 1%
Endotracheal tube cuff inflation with lidocaine 1%
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.
Lidocaine 2%
Endotracheal tube cuff inflation with Lidocaine 2%
cuff inflation with lidocaine 2%
Endotracheal tube cuff inflation with lidocaine 2%
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.
Interventions
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cuff inflation with air
Endotracheal tube cuff inflation with air
cuff inflation with lidocaine 1%
Endotracheal tube cuff inflation with lidocaine 1%
cuff inflation with lidocaine 2%
Endotracheal tube cuff inflation with lidocaine 2%
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.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists classification (ASA) category 1 or 2
* High pressure, low volume endotracheal tube - (Lo-pro)
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Ogarite Habib
OTHER
Responsible Party
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Ogarite Habib
Principal Investigator
Principal Investigators
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Hicham Jabbour, MD
Role: STUDY_DIRECTOR
Saint JU
Central Contacts
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Other Identifiers
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CEHDF 1263
Identifier Type: -
Identifier Source: org_study_id
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