A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation

• Published in: Gastrointestinal endoscopy 2011, Vol.73 (1), p.103-110
• Main Authors: Leung, Joseph, MD, FRCP, FACP, MACG, FASGE, Mann, Surinder, MD, FACP, FACG, AGAF, Siao-Salera, Rodelei, RN, CGRN, Ransibrahmanakul, Kanat, MD, Lim, Brian, MD, Canete, Wilhelmina, RN, CGRN, Samson, Laramie, RN, Gutierrez, Rebeck, RN, BSN, Leung, Felix W., MD, FACG
• Format: Article
• Language: English
• Subjects: Aged; Air; Analgesics, Opioid - administration & dosage; Anesthesia; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Colonoscopy - methods; Conscious Sedation; Digestive system. Abdomen; Endoscopy; Female; Fentanyl - administration & dosage; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; General anesthesia. Technics. Complications. Neuromuscular blocking. Premedication. Surgical preparation. Sedation; Humans; Hypnotics and Sedatives - administration & dosage; Intention to Treat Analysis; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Midazolam - administration & dosage; Middle Aged; Patient Satisfaction; Single-Blind Method; United States; Veterans; Water - administration & dosage
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2010.09.020

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 .)