Pharyngitis
Conditions
Keywords
lidocaine, tetracaine, tracheal intubation, pharyngitis
Brief summary
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.
Detailed description
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of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted.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.
Interventions
DRUG2% lidocaine
lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
DRUGplacebo
Air injected into the cuff to seal the space between the trachea and the tube at minimal volume
DRUG1% tetracaine
tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
DRUGN.S
0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume
Sponsors
Sichuan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* patients of the age group 18-60 years * patients belonging to ASA grade I and II undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using Poly Vinyl Chloride ETT (same type and make in all patients)
Exclusion criteria
* anticipated difficult intubation * more than one attempt for intubation * need for naso gastric tube * episode of coughing and straining * history of respiratory tract infection and smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale(0-100mm) by the Subject. | 6 hours, 12 hours, 24 hours, 48 hours after extubation | 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. |
Countries
China
Participant flow
Recruitment details
The study started in November 2008 and finished in February 2009, in total 100 patients were enrolled and all of them finished this study.
Participants by arm
| Arm | Count |
|---|---|
| Air Alone Only air was injected into the cuff, as the routine practice | 25 |
| Normal Saline normal saline was used to inflate the cuff | 25 |
| Lidocaine 2% lidiocaine was used to inflate the cuff | 25 |
| Tetracaine 1% tetracaine was used to inflate the cuff | 25 |
| Total | 100 |
Baseline characteristics
| Characteristic | Normal Saline | Lidocaine | Air Alone | Tetracaine | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 25 Participants | 25 Participants | 100 Participants |
| Age Continuous | 44 years STANDARD_DEVIATION 9 | 42 years STANDARD_DEVIATION 7 | 39 years STANDARD_DEVIATION 8 | 41 years STANDARD_DEVIATION 10 | 42 years STANDARD_DEVIATION 9 |
| Region of Enrollment China | 25 participants | 25 participants | 25 participants | 25 participants | 100 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 25 Participants | 25 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 6 hours, 12 hours, 24 hours, 48 hours after extubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Air Alone | Visual Analogue Scale(0-100mm) by the Subject. | 6h | 51 mm | Standard Deviation 37 |
| Air Alone | Visual Analogue Scale(0-100mm) by the Subject. | 12h | 50 mm | Standard Deviation 33 |
| Air Alone | Visual Analogue Scale(0-100mm) by the Subject. | 24h | 43 mm | Standard Deviation 39 |
| Air Alone | Visual Analogue Scale(0-100mm) by the Subject. | 48h | 45 mm | Standard Deviation 36 |
| Normal Saline | Visual Analogue Scale(0-100mm) by the Subject. | 12h | 38 mm | Standard Deviation 19 |
| Normal Saline | Visual Analogue Scale(0-100mm) by the Subject. | 24h | 41 mm | Standard Deviation 30 |
| Normal Saline | Visual Analogue Scale(0-100mm) by the Subject. | 48h | 43 mm | Standard Deviation 25 |
| Normal Saline | Visual Analogue Scale(0-100mm) by the Subject. | 6h | 40 mm | Standard Deviation 31 |
| Lidocaine | Visual Analogue Scale(0-100mm) by the Subject. | 24h | 20 mm | Standard Deviation 18 |
| Lidocaine | Visual Analogue Scale(0-100mm) by the Subject. | 12h | 25 mm | Standard Deviation 15 |
| Lidocaine | Visual Analogue Scale(0-100mm) by the Subject. | 48h | 23 mm | Standard Deviation 19 |
| Lidocaine | Visual Analogue Scale(0-100mm) by the Subject. | 6h | 22 mm | Standard Deviation 17 |
| Tetracaine | Visual Analogue Scale(0-100mm) by the Subject. | 48h | 9 mm | Standard Deviation 4 |
| Tetracaine | Visual Analogue Scale(0-100mm) by the Subject. | 12h | 13 mm | Standard Deviation 7 |
| Tetracaine | Visual Analogue Scale(0-100mm) by the Subject. | 6h | 9 mm | Standard Deviation 8 |
| Tetracaine | Visual Analogue Scale(0-100mm) by the Subject. | 24h | 7 mm | Standard Deviation 5 |