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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%).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air | Active Comparator | Endotracheal tube cuff inflation with air |
|
| Lidocaine 1% | Experimental | Endotracheal tube cuff inflation with Lidocaine 1% |
|
| Lidocaine 2% | Experimental | Endotracheal tube cuff inflation with Lidocaine 2% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cuff inflation with air | Other | Endotracheal tube cuff inflation with air |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ogarite P Habib, MD | Contact | +9613722518 | Ogarite.habib@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hicham Jabbour, MD | Saint JU | Study Director |
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| cuff inflation with lidocaine 1% |
| Drug |
Endotracheal tube cuff inflation with lidocaine 1% |
|
| cuff inflation with lidocaine 2% | Drug | Endotracheal tube cuff inflation with 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. |
|
| 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). |
|
| 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). |
|
| Systematic post-operative analgesia | Other | All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery. |
|
| 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 |
| ID | Term |
|---|---|
| D000388 | Air |
| D007442 | Intubation, Intratracheal |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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