The combination of simethicone, N acetylcysteine and lidocaine in ice popsicle compared with lidocaine ice popsicle alone in patients undergoing unsedated esophagogastroduodenoscopy
Phase 3
Recruiting
- Registration Number
- TCTR20240606004
- Lead Sponsor
- Faculty of Medicine, Thammasat University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 384
Inclusion Criteria
A minimum age of 20 years
Eligible for unsedated diagnostic EGD via the oral route by pharyngeal anesthesia at Thammasat University Hospital
Cancer screening and work-up for symptomatic patients in patients with dysphagia, dyspepsia, reflux, abdominal pain, or anemia
Patients who did not have allergy and contraindications to pre-medications with a compound solution (simethicone, N-acetylcysteine and lidocaine )
All patients were fully informed of the purpose of this study and consent was obtained from all participants before this study
Exclusion Criteria
Patients with previous upper GI surgery
Patients with severe dysphagia
Patients with history of corrosive ingestion
Pregnant patients
Patients with hemodynamic instability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total visibility score Post EGD Score
- Secondary Outcome Measures
Name Time Method Amount of water used to allow suitable visualisation of gastric mucosa Post EGD mL,Time to complete EGD Post EGD minutes,Safety outcome During EGD q 15 mins Oxygen desaturation (%),Safety outcome During EGD q 15 mins Hypotension (mmHg),Safety outcome During EGD q 15 mins Bradycardia (bpm),Endoscopist satisfaction Post EGD numerical rating scale,Patient satisfaction Post EGD numerical rating scale