Comparing the Efficacy and Safety of Dexmedetomidine/Ketamine with Propofol/Fentanyl for Sedation in Colonoscopy Patients: A Double-blinded Randomized Clinical Trial

Background: In this double-blinded randomized clinical trial, we aimed to compare the safety and efficacy of a combination of Dexmedetomidine and Ketamine (DK) with Propofol and Fentanyl (PF) for sedation in colonoscopy patients. Methods: In this study, 64 patients who underwent colonoscopy were randomized into two groups: 1) A, which received PF, and 2) B, which received DK for sedation. Among 64 patients, 31 patients were included in PF, and 33 patients were included in the DK group. Both groups were similar in terms of demographics. Patients' sedation score (based on Ramsay sedation scale) and vital signs were recorded at 2, 5, 10, and 15 minutes. Complications including apnea, hypotension, hypoxia, nausea, and vomiting, along with gastroenterologist satisfaction and patients' pain score (based on Wong-Baker faces pain assessment scale), were recorded by a checklist. Data were analyzed by SPSS v.18 software, using chi-square, independent t-tests, and repeated measures analysis with p<0.05 as the criterion for significant differences. Results: The mean score of sedation was 4.820.49 in the DK group and 5.220.45 in the PF group (p value=0.001). Serious complications, including hypotension (p value=0.005) and apnea (p value=0.10) were significantly higher in the PF group. Satisfaction of gastroenterologist (p value= 0.400) and patients' pain score (p value = 0.900) were similar among groups. Conclusion: Combination of DK provides sufficient sedation with fewer complications in comparison with PF in colonoscopy patients. Clinical Trial Registration No.: The study was also registered at the Iranian Center for Clinical Trials (No. IRCT20161205031252N11).