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It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.
The female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak around the tube by the Minimal Occlusive Volume Technique. This was done by the same anaesthesiologist in all the patients. The cuff volume and pressure were then recorded. The primary outcome of the study was to evaluate the post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation. The secondary outcomes were incidence of complications during emergence of anesthesia and after extubation. Intra-cuff pressure monitoring was done with a pressure monitor, which consisted of the pressure gauge, three-way stopcock whose one end was attached to the pressure monitoring line. Net volume of the inflation medium was noted. Volume of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted. Incidence (Yes/No) of tube intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient belonged to.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air | Placebo Comparator | air was used to inflate the cuff. |
|
| Normal Saline | Placebo Comparator | Normal saline was used to inflate the cuff. |
|
| lidocaine | Active Comparator | 2% lidocaine was used to inflate the cuff. |
|
| tetracaine | Experimental | 1% tetracaine was used to inflate the cuff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% lidocaine | Drug | lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale(0-100mm) by the Subject. | visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels. | 6 hours, 12 hours, 24 hours, 48 hours after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han Huang, M.D | Department of Aensthesiology, West China 2nd Hospital, Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, West China Second Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14970135 | Background | Estebe JP, Delahaye S, Le Corre P, Dollo G, Le Naoures A, Chevanne F, Ecoffey C. Alkalinization of intra-cuff lidocaine and use of gel lubrication protect against tracheal tube-induced emergence phenomena. Br J Anaesth. 2004 Mar;92(3):361-6. doi: 10.1093/bja/aeh078. |
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The study started in November 2008 and finished in February 2009, in total 100 patients were enrolled and all of them finished this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Alone | Only air was injected into the cuff, as the routine practice |
| FG001 | Normal Saline | normal saline was used to inflate the cuff |
| FG002 | Lidocaine | 2% lidiocaine was used to inflate the cuff |
| FG003 | Tetracaine | 1% tetracaine was used to inflate the cuff |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Air Alone | Only air was injected into the cuff, as the routine practice |
| BG001 | Normal Saline | normal saline was used to inflate the cuff |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale(0-100mm) by the Subject. | visual analogue scale (VAS) was used to evaluate the post-intubation sore throat. The VAS was a well-recongnized standard tool for rating of pain. The VAS measures exactly 100 mm. 0 means no pain and 100 means the worst pain that one can image. Patient marks a point on the line that matches the amount of pain he or she feels. | Posted | Mean | Standard Deviation | mm | 6 hours, 12 hours, 24 hours, 48 hours after extubation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air Alone | Only air was injected into the cuff, as the routine practice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Han Huang | Department of Anesthesiology, West China Second Hospital | 80-028-8550-3753 | huanghan1981@hotmail.com |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| placebo | Drug | Air injected into the cuff to seal the space between the trachea and the tube at minimal volume |
|
| 1% tetracaine | Drug | tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume |
|
| N.S | Drug | 0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume |
|
| BG002 | Lidocaine | 2% lidiocaine was used to inflate the cuff |
| BG003 | Tetracaine | 1% tetracaine was used to inflate the cuff |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Lidocaine |
2% lidiocaine was used to inflate the cuff |
| OG003 | Tetracaine | 1% tetracaine was used to inflate the cuff |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Normal Saline | normal saline was used to inflate the cuff | 0 | 25 | 0 | 25 |
| EG002 | Lidocaine | 2% lidiocaine was used to inflate the cuff | 0 | 25 | 0 | 25 |
| EG003 | Tetracaine | 1% tetracaine was used to inflate the cuff | 0 | 25 | 0 | 25 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |