An interventional study of 2% lidocaine and placebo in Pharyngitis, sponsored by Sichuan University. Completed at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-12-18.
Sponsored by Sichuan University · Not applicable, Interventional, and Prevention
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of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted.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.
252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.
This study's enrollment of 100 is below the median of 144 across 209 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
air was used to inflate the cuff.
Drug: placebo
Normal saline was used to inflate the cuff.
Drug: N.S
2% lidocaine was used to inflate the cuff.
Drug: 2% lidocaine
1% tetracaine was used to inflate the cuff.
Drug: 1% tetracaine
lidocaine: 2%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
Air injected into the cuff to seal the space between the trachea and the tube at minimal volume
tetracaine: 1%, injected into the cuff to seal the space between the trachea and the tube at minimal volume
0.9% Normal saline injected into the cuff to seal the space between the trachea and the tube at minimal volume
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
The study started in November 2008 and finished in February 2009, in total 100 patients were enrolled and all of them finished this study.
| Milestone | Air Alone | Normal Saline | Lidocaine | Tetracaine |
|---|---|---|---|---|
| Started | 25 | 25 | 25 | 25 |
| Completed | 25 | 25 | 25 | 25 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| mm | Air Alone | Normal Saline | Lidocaine | Tetracaine |
|---|---|---|---|---|
| 6h | 51 ± 37 | 40 ± 31 | 22 ± 17 | 9 ± 8 |
| 12h | 50 ± 33 | 38 ± 19 | 25 ± 15 | 13 ± 7 |
| 24h | 43 ± 39 | 41 ± 30 | 20 ± 18 | 7 ± 5 |
| 48h | 45 ± 36 | 43 ± 25 | 23 ± 19 | 9 ± 4 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Air Alone | — | 0/25 (0%) | 0/25 (0%) |
| Normal Saline | — | 0/25 (0%) | 0/25 (0%) |
| Lidocaine | — | 0/25 (0%) | 0/25 (0%) |
| Tetracaine | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Air Alone | Normal Saline | Lidocaine | Tetracaine | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 25 | 25 | 25 | 100 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age Continuous(years) | Air Alone | Normal Saline | Lidocaine | Tetracaine | Total |
|---|---|---|---|---|---|
| Mean | 39 ± 8 | 44 ± 9 | 42 ± 7 | 41 ± 10 | 42 ± 9 |
| Sex: Female, Male(Participants) | Air Alone | Normal Saline | Lidocaine | Tetracaine | Total |
|---|---|---|---|---|---|
| Female | 25 | 25 | 25 | 25 | 100 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Air Alone | Normal Saline | Lidocaine | Tetracaine | Total |
|---|---|---|---|---|---|
| China | 25 | 25 | 25 | 25 | 100 |
This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Sichuan University