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An in vitro and clinical dose-finding study of antifoaming effects of simethicone during colonoscopy
Marguerite J Kutyla1,2, Ayesha Shah1,3, Jerome Elson1
1Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
Abstract:
Simethicone is an antifoaming agent frequently added to endoscopic rinse solutions but has recently been implicated as a risk factor for transmission of infections due to the formation of simethicone deposits within scope channels. Since the build-up of residue is likely dose-related, the smallest effective dose of simethicone should be used but there are no data available on the effective dose. Thus, we conducted a dose-finding study in an "in vitro bubble model" to determine the appropriate simethicone dose. Six 100-mL test tubes were filled with a 1% (v/v) solution of kitchen detergent (Fairy®, Procter & Gamble, London, England) in water for irrigation (Baxter®, Sydney, Australia). One test tube served as the control, while different doses of simethicone (Infacol®, Nice Pak, Melbourne, Australia) were added to the other five tubes (0.02, 0.2, 2.0, 20, and 200 mg/100 mL). Oxygen was streamed for 30 s into the test tubes at a rate of 2 L/min. After 10 s, photographs were taken and the visible bubbles were semi-quantitatively rated by independent assessors blinded to the dosing of simethicone. Simethicone at doses of 2 mg/100 mL had no appreciable antifoaming effect, whereas concentrations ≥ 20 mg/100 mL were sufficient to suppress bubble formation. This is substantially lower compared with frequently used doses of up to 200 mg/100 mL. Subsequently, we tested the lower simethicone dose with previously used higher doses, in 1475 and 1340 patients, respectively. We found it to have no impact on polyp detection with a rate of 56.7% (54.2-59.3% [95% CI]) at the lower dose and 56.5% (53.8-59.1% [95% CI]) at the higher dose.
Insights
The smallest effective dose of simethicone for endoscopic procedures is 20 mg/100 mL, significantly lower than current usage. This reduced dose did not impact polyp detection rates in clinical trials.
Area of Science:
- Gastroenterology
- Medical Device Cleaning
- Infection Control
Background:
- Simethicone is an antifoaming agent used in endoscopic rinse solutions.
- Concerns exist regarding simethicone deposits in scope channels, potentially transmitting infections.
- The optimal, minimal effective dose of simethicone is unknown, necessitating dose-finding studies.
Purpose of the Study:
- To determine the minimal effective dose of simethicone for antifoaming in endoscopic rinse solutions.
- To evaluate the impact of reduced simethicone dosage on polyp detection rates in patients undergoing endoscopy.
Main Methods:
- An in vitro bubble model was used to test varying simethicone concentrations (0.02–200 mg/100 mL).
- Oxygen was streamed into detergent solutions, and bubble formation was assessed semi-quantitatively.
- A lower effective dose identified in vitro was subsequently tested in two patient cohorts (1475 and 1340 patients).
Main Results:
- Simethicone concentrations of 20 mg/100 mL and above effectively suppressed bubble formation.
- Doses of 2 mg/100 mL showed no significant antifoaming effect.
- Polyp detection rates were similar between the lower effective simethicone dose and previously used higher doses (56.7% vs. 56.5%).
Conclusions:
- The minimal effective dose of simethicone is 20 mg/100 mL, which is substantially lower than commonly used concentrations.
- Using the minimal effective dose of simethicone does not compromise polyp detection during endoscopy.
- Reducing simethicone dosage may mitigate risks associated with simethicone deposits in endoscope channels.
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