Lugol chromoendoscopy is essential in detecting and characterizing squamous cell carcinoma of esophagus. Esophageal irritating symptom has been reported as an common adverse event, which could be alleviated by sodium thiosulfate solutions. However, sodium thiosulfate was not widely available. N-acetylcysteine has been previously used as a mucolytic reagent, we propose that it may also be used to alleviate irritating symptoms caused by Lugo's chromoendoscopy. A prospective, non-inferior, randomized double-blind clinical trial was designed to study the efficacy of N-acetylcysteine solutions in relieving esophageal discomfort .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
140
use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China
Mean Visual analogue scale change
Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy
Time frame: 30 minute after endoscopy
Rate of patients with symptom
The percentage of patients with symptom after Lugol chromoendoscopy for certain time
Time frame: 5 minute or 30 minute or 24 hour after endoscopy
Neutralization rate
Neutralizing effect for residual iodine in esophagus and stomach
Time frame: During endoscopy
Heart rate variability
the percentage of heart rate change 5 min or 30 min compared to that Before endoscopy
Time frame: 5 minute or 30 minute after endoscopy
Severe discomfort rate
the percentage of patient with Visual analogue scale over 4
Time frame: 5 minute or 30 minute after endoscopy
exam time
the time of endoscopy from the beginning of spraying diluted Lugol's solution to end of endoscopy minus time required for biopsy.
Time frame: during endoscopy
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