BACKGROUND: Sedation for colonoscopy discomfort imposes a recovery-time burden on patients. The water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without sedation. On-site and at-home recovery times were not reported. OBJECTIVE: To confirm the beneficial effect of the water method and document the patient recovery-time burden. DESIGN: Randomized, controlled trial, with single-blinded, intent-to-treat analysis. SETTING:Veterans Affairs outpatient endoscopy unit. PATIENTS: This study involved veterans accepting on-demand sedation for screening and surveillance colonoscopy. INTERVENTION: Air versus water method for colonoscope insertion. MAIN OUTCOME MEASUREMENTS: Proportion of patients completing colonoscopy without sedation, cecal intubation rate, medication requirement, maximum discomfort (0 = none, 10 = severe), procedure-related and patient-related outcomes. RESULTS:One hundred veterans were randomized to the air (n = 50) or water (n = 50) method. The proportions of patients who could complete colonoscopy without sedation in the water group (78%) and the air group (54%) were significantly different (P = .011, Fisher exact test), but the cecal intubation rate was similar (100% in both groups). Secondary analysis (data as Mean [SD]) shows that the water method produced a reduction in medication requirement: fentanyl, 12.5 (26.8) μg versus 24.0 (30.7) μg; midazolam, 0.5 (1.1) mg versus 0.94 (1.20) mg; maximum discomfort, 2.3 (1.7) versus 4.9 (2.0); recovery time on site, 8.4 (6.8) versus 12.3 (9.4) minutes; and recovery time at home, 4.5 (9.2) versus 10.9 (14.0) hours (P = .049; P = .06; P = .0012; P = .0199; and P = .0048, respectively, t test). LIMITATIONS: Single Veterans Affairs site, predominantly male population, unblinded examiners. CONCLUSION: This randomized, controlled trial confirms the reported beneficial effects of the water method. The combination of the water method with on-demand sedation minimizes the patient recovery-time burden. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00920751.).
RCT Entities:
BACKGROUND: Sedation for colonoscopy discomfort imposes a recovery-time burden on patients. The water method permitted 52% of patients accepting on-demand sedation to complete colonoscopy without sedation. On-site and at-home recovery times were not reported. OBJECTIVE: To confirm the beneficial effect of the water method and document the patient recovery-time burden. DESIGN: Randomized, controlled trial, with single-blinded, intent-to-treat analysis. SETTING: Veterans Affairs outpatient endoscopy unit. PATIENTS: This study involved veterans accepting on-demand sedation for screening and surveillance colonoscopy. INTERVENTION: Air versus water method for colonoscope insertion. MAIN OUTCOME MEASUREMENTS: Proportion of patients completing colonoscopy without sedation, cecal intubation rate, medication requirement, maximum discomfort (0 = none, 10 = severe), procedure-related and patient-related outcomes. RESULTS: One hundred veterans were randomized to the air (n = 50) or water (n = 50) method. The proportions of patients who could complete colonoscopy without sedation in the water group (78%) and the air group (54%) were significantly different (P = .011, Fisher exact test), but the cecal intubation rate was similar (100% in both groups). Secondary analysis (data as Mean [SD]) shows that the water method produced a reduction in medication requirement: fentanyl, 12.5 (26.8) μg versus 24.0 (30.7) μg; midazolam, 0.5 (1.1) mg versus 0.94 (1.20) mg; maximum discomfort, 2.3 (1.7) versus 4.9 (2.0); recovery time on site, 8.4 (6.8) versus 12.3 (9.4) minutes; and recovery time at home, 4.5 (9.2) versus 10.9 (14.0) hours (P = .049; P = .06; P = .0012; P = .0199; and P = .0048, respectively, t test). LIMITATIONS: Single Veterans Affairs site, predominantly male population, unblinded examiners. CONCLUSION: This randomized, controlled trial confirms the reported beneficial effects of the water method. The combination of the water method with on-demand sedation minimizes the patient recovery-time burden. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00920751.).
Authors: Fw Leung; Jo Harker; Jw Leung; Rm Siao-Salera; Sk Mann; Fc Ramirez; S Friedland; A Amato; F Radaelli; S Paggi; V Terruzzi; Yh Hsieh Journal: J Interv Gastroenterol Date: 2011-07-01
Authors: Fw Leung; Jo Harker; Jw Leung; Rm Siao-Salera; Sk Mann; Fc Ramirez; S Friedland; A Amato; F Radaelli; S Paggi; V Terruzzi; Yh Hsieh Journal: J Interv Gastroenterol Date: 2011-07-01
Authors: Joseph W Leung; Rodelei Siao-Salera; Ovanes Abramyan; Surinder K Mann; Gregory Ward; Andrew Yen; Rebeck Gutierrez; Felix W Leung Journal: Dig Dis Sci Date: 2013-11-20 Impact factor: 3.199
Authors: Felix W Leung; Yanglin Pan; Surinder K Mann; Joseph W Leung; Rodelei M Siao-Salera; Guy Jackson Journal: J Interv Gastroenterol Date: 2012-07-01