Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough (ELIT)
Primary Purpose
Postoperative Sore Throat, Postoperative Cough
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cuff inflation with air
cuff inflation with lidocaine 1%
cuff inflation with lidocaine 2%
Induction of anesthesia
Maintenance of anesthesia
Endotracheal intubation
Systematic post-operative analgesia
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Sore Throat focused on measuring Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation
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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Air
Lidocaine 1%
Lidocaine 2%
Arm Description
Endotracheal tube cuff inflation with air
Endotracheal tube cuff inflation with Lidocaine 1%
Endotracheal tube cuff inflation with Lidocaine 2%
Outcomes
Primary Outcome Measures
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))
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))
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))
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))
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))
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))
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))
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))
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03792776
Brief Title
Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough
Acronym
ELIT
Official Title
Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ogarite Habib
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat, Postoperative Cough
Keywords
Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Air
Arm Type
Active Comparator
Arm Description
Endotracheal tube cuff inflation with air
Arm Title
Lidocaine 1%
Arm Type
Experimental
Arm Description
Endotracheal tube cuff inflation with Lidocaine 1%
Arm Title
Lidocaine 2%
Arm Type
Experimental
Arm Description
Endotracheal tube cuff inflation with Lidocaine 2%
Intervention Type
Other
Intervention Name(s)
cuff inflation with air
Intervention Description
Endotracheal tube cuff inflation with air
Intervention Type
Drug
Intervention Name(s)
cuff inflation with lidocaine 1%
Intervention Description
Endotracheal tube cuff inflation with lidocaine 1%
Intervention Type
Drug
Intervention Name(s)
cuff inflation with lidocaine 2%
Intervention Description
Endotracheal tube cuff inflation with lidocaine 2%
Intervention Type
Other
Intervention Name(s)
Induction of anesthesia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Maintenance of anesthesia
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Endotracheal intubation
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Systematic post-operative analgesia
Intervention Description
All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
Primary Outcome Measure Information:
Title
Sore throat intensity 0
Description
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Time Frame
hour 0 after extubation
Title
Sore throat intensity 2
Description
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Time Frame
at 2 hours after extubation
Title
Sore throat intensity 6
Description
Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Time Frame
at 6 hours after extubation
Title
Sore throat intensity 24
Description
Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
Time Frame
at 24 hours after extubation
Title
Cough intensity 0
Description
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Time Frame
hour 0 after extubation
Title
Cough intensity 2
Description
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Time Frame
at 2 hours after extubation
Title
Cough intensity 6
Description
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Time Frame
at 6 hours after extubation
Title
Cough intensity 24
Description
Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Time Frame
at 24 hours after extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ogarite P Habib, MD
Phone
+9613722518
Email
Ogarite.habib@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hicham Jabbour, MD
Organizational Affiliation
Saint JU
Official's Role
Study Director
12. IPD Sharing Statement
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Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough
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