Background and Goal of Study: A combination of opioids and benzodiazepines or propofol is usually used to achieve sedation and analgesia during colonoscopy. Few studies have compared their efficacy. The aim of this study was to compare and evaluate the clinical efficacy of the combination of midazolam and fentanyl versus propofol and pethidine when each regimen is used as sedative agents for colonoscopy.
Materials and Methods: 1,032 patients who underwent colonoscopy in two years, were randomly assigned to MF and PP groups. 514 patients in group MF received midazolam and fentanyl and 518 patients in group PP received propofol and pethidine for intravenous sedation (IVS). The maximum dose of midazolam, fentanyl and pethidine was not higher than 0.08, 0.003 and 2.0 mg/kg, respectively. The primary outcome variable was the successfully completed colonoscopic procedure. The secondary outcome variables were patient tolerance, discomfort during insertion, patient and endoscopist satisfaction, hemodynamic responses, as well as complications during and immediately after procedure.
Results and Discussion: All endoscopies were completely successfully except for 33 patients (6.4%) in group MF and 11 patients (3.3%) in group PP (p=0.019). Mean total dose of midazolam and fentanyl in group MF was 0.08 (0.05) mg/hg/hr and 0.003 (0.002) mg/kg/hr. Mean total dose of propofol and pethidine in group PP was 5.98 (2.67) mg/hg/hr and 1.74 (1.05) mg/kg/hr. Additional propofol dose in group MF was 86.97 (19.60) mg, and in group PP was 38.82 (17.64) mg (p<0.001). Procedural pain and recovery time in group MF was significantly higher than in group PP (p<0.001), but recovery score at 30 min post-procedure in group MF was significantly lower than group PP (p<0.001). Tolerability of the patient, discomfort during insertion as well as patient and endoscopist satisfaction in group MF were statistically significantly lower than for patients in group PP (p<0.001). Overall, cardiovascular and respiratory adverse events in group PP were also significantly higher than in group MF. However, these adverse events were transient and easily treated with no sequelae.
Conclusion(s): IVS in both regimens provided effective and safe for colonoscopy. No serious adverse events were observed. However, the combination of propofol and pethidine used as sedative agents for IVS had significantly higher efficacy than the combination of midazolam and fentanyl.