Xueqin Chen1, Ning Dai1, Yanyong Deng1, Xin Sun2, Mingqing Zhang3, Jie Pan4, Zhiming Huang5, Guoliang Ye6, Jianmin Si1, Lan Wang7, Shujie Chen8. 1. Department of Gastroenterology, Sir Run Run Shaw Hospital Affiliated To Zhejiang University, 3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China. 2. Department of Endoscopy Lab, Qingdao Municipal Hospital, 1 Jiaozhou Road, North District, Qingdao, Shangdong, China. 3. Department of Gastroenterology, Affiliated Dongnan Hospital of Xiamen University, 269 Huazhong Road, Longwen District, Zhangzhou, Fujian, China. 4. Department of Gastroenterology, Wenzhou City Second People's Hospital, 32 Dajane Lane, Wenzhou, Zhejiang, China. 5. Department of Gastroenterology, Wenzhou Medical University First Affiliated Hospital, Cai Village on the South White Elephant Street, Ouhai District, Wenzhou, Zhejiang, China. 6. Ningbo City Third Hospital, 247 People's Road, Jiangbei District, Ningbo, Zhejiang, China. 7. Department of Gastroenterology, Sir Run Run Shaw Hospital Affiliated To Zhejiang University, 3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China. 3410001@zju.edu.cn. 8. Department of Gastroenterology, Sir Run Run Shaw Hospital Affiliated To Zhejiang University, 3 Qingchun Road East, Jianggan District, Hangzhou, Zhejiang, China. chenshujie77@zju.edu.cn.
Abstract
BACKGROUND: The reformulated simethicone emulsion from Berlin Chemical AG might develop white flocculate precipitate covering the gastric mucosa when used before esophagogastroduodenoscopy (EGD). We aim to investigate whether combining the reformulated simethicone emulsion with 5% sodium bicarbonate solution could prevent the development of white precipitate and improve visibility during EGD. METHODS: Our clinical study involved 523 patients. They were randomly assigned to two groups. In Group A, patients received a warm solution containing 30 ml 5% sodium bicarbonate solution and 15 ml reformulated simethicone emulsion. In Group B, patients received 45 ml 40 °C lukewarm water. Visibility scores were recorded and analyzed. Flushes, volume of flush water, overall time taken for EGD and complications during or after the procedure were also recorded. RESULTS: We found that no white precipitate was observed during EGD in Group A. Moreover, visibility scores in Group A were significantly lower (P < 0.01). Patients in Group A had fewer flushes (P < 0.01) and smaller volume of flush water (P < 0.01). In addition, the overall time taken for the EGD procedure was significantly shorter in Group A (P < 0.01). The percentage of patients who had no adverse response was significantly higher in Group A than in Group B (P < 0.01). CONCLUSIONS: Premedication with a mixed solution of 15 ml reformulated simethicone emulsion and 30 ml 5% sodium bicarbonate solution can prevent the development of white precipitate, substantially enhancing mucosal visibility safely. TRIAL REGISTRATION: The registered name of the trial is "Efficacy of using premedication with reformulated simethicone emulsion during upper gastrointestinal endoscopy examination". Its Current Controlled Trials number is ChiCTR1900021689. Its date of registration is 11 September 2019. Retrospectively registered, http://www.medresman.org.cn/uc/sindex.aspx .
RCT Entities:
BACKGROUND: The reformulated simethicone emulsion from Berlin Chemical AG might develop white flocculate precipitate covering the gastric mucosa when used before esophagogastroduodenoscopy (EGD). We aim to investigate whether combining the reformulated simethicone emulsion with 5% sodium bicarbonate solution could prevent the development of white precipitate and improve visibility during EGD. METHODS: Our clinical study involved 523 patients. They were randomly assigned to two groups. In Group A, patients received a warm solution containing 30 ml 5% sodium bicarbonate solution and 15 ml reformulated simethicone emulsion. In Group B, patients received 45 ml 40 °C lukewarm water. Visibility scores were recorded and analyzed. Flushes, volume of flush water, overall time taken for EGD and complications during or after the procedure were also recorded. RESULTS: We found that no white precipitate was observed during EGD in Group A. Moreover, visibility scores in Group A were significantly lower (P < 0.01). Patients in Group A had fewer flushes (P < 0.01) and smaller volume of flush water (P < 0.01). In addition, the overall time taken for the EGD procedure was significantly shorter in Group A (P < 0.01). The percentage of patients who had no adverse response was significantly higher in Group A than in Group B (P < 0.01). CONCLUSIONS: Premedication with a mixed solution of 15 ml reformulated simethicone emulsion and 30 ml 5% sodium bicarbonate solution can prevent the development of white precipitate, substantially enhancing mucosal visibility safely. TRIAL REGISTRATION: The registered name of the trial is "Efficacy of using premedication with reformulated simethicone emulsion during upper gastrointestinal endoscopy examination". Its Current Controlled Trials number is ChiCTR1900021689. Its date of registration is 11 September 2019. Retrospectively registered, http://www.medresman.org.cn/uc/sindex.aspx .
Entities:
Keywords:
Esophagogastroduodenoscopy; Reformulated simethicone emulsion; Sodium bicarbonate; White flocculate precipitate
Authors: Jonathan Cohen; Michael A Safdi; Stephen E Deal; Todd H Baron; Amitabh Chak; Brenda Hoffman; Brian C Jacobson; Klaus Mergener; Bret T Petersen; John L Petrini; Douglas K Rex; Douglas O Faigel; Irving M Pike Journal: Am J Gastroenterol Date: 2006-04 Impact factor: 10.864
Authors: P Bhandari; S Green; H Hamanaka; T Nakajima; T Matsuda; Y Saito; I Oda; T Gotoda Journal: Scand J Gastroenterol Date: 2010-03 Impact factor: 2.423