The combination of simethicone, N acetylcysteine and lidocaine in ice popsicle compared with lidocaine ice popsicle alone in patients undergoing unsedated esophagogastroduodenoscopy

The combination of simethicone, N acetylcysteine and lidocaine in ice popsicle compared with lidocaine ice popsicle alone in patients undergoing unsedated esophagogastroduodenoscopy.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240606004

Enrollment

384

Registered

2024-06-06

Start date

2023-12-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper gastrointestinal endoscopy, called esophagogastroduodenoscopy (EGD), is a diagnostic endoscopic procedure and the standard functions are inspection , biopsy , photography ,and video recording. EGD affords an excellent view of mucosal surfaces of the upper gastrointestinal tract including esophagus, stomach, and proximal duodenum. The symptoms indicate EGD including epigastrium pain , dyspepsia , dysphagia , reflux , and anemia. Therefore, EGD plays a key role in early cancer detection and

Interventions

lidocaine ice popsicle with simethicone and NAC 600 mg ,lidocaine ice popsicle formulation

Experimental Drug,Sham Comparator Drug

Lidocaine Ice Popsicle with pre-medication agents ,Lidocaine Ice Popsicle Alone

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Patients with previous upper GI surgery Patients with severe dysphagia Patients with history of corrosive ingestion Pregnant patients Patients with hemodynamic instability

Design outcomes

Primary

Measure	Time frame
Total visibility score Post EGD Score	—

Secondary

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactPailin Intarasangkhanawin

Faculty of medicine, Thammasat University

ingpailinin@gmail.com0840547060

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026