Randomized Controlled Study Comparing Use of Propofol Plus Fentanyl versus Midazolam Plus Fentanyl as Sedation in Diagnostic Endoscopy in Patients with Advanced Liver Disease

Abstract

Objectives We aimed to investigate the safety and efficacy of propofol plus fentanyl versus midazolam plus fentanyl as sedative for patients with advanced liver disease presented for gastrointestinal endoscopy. Methods A total of 100 patients with liver cirrhosis referred for upper endoscopy were enrolled and divided equally in two groups, midazolam plus fentanyl group and propofol plus fentanyl group. All patients were subjected to history taking, estimation of level of sedation, endoscopist rating, and hemodynamic parameters including oxygen saturation, heart rate, mean arterial pressure, incidence of side effect as (bradycardia, hypotension, hypoxia, nausea and vomiting, cough, shivering, or diplopia), time needed for complete recovery, and time needed for discharge. Results There was no statistical significant difference between the studied groups regarding age, sex, weight, Child–Pugh classification score, type and duration of endoscopic intervention, time needed for complete recovery, or time needed for discharge. Complication rates were similar in both groups except for mean arterial blood pressure which was significantly lower in group of patients receiving propofol and fentanyl (P = 0.001). Conclusion The use of either propofol or midazolam in combination to fentanyl is effective in sedation of patients with advanced liver diseases presented for upper GIT endoscope. The trial is registered with ClinicalTrials.gov Identifier: NCT03063866.

Propofol vs midazolam sedation for elective endoscopy in patients with cirrhosis: A systematic review and meta-analysis of randomized controlled trials

“…Four studies[ 15 - 18 ] used sedation with only propofol or midazolam. The other four studies[ 19 - 22 ] also used additional medications for sedation, such as opioid analgesic Pentazocine (Watanabe et al[ 19 ]), fentanyl (Ahmed et al[ 20 ] and Correia et al[ 21 ]) and Meperidine in the midazolam group (Weston et al[ 22 ]).…”

“…Risk of bias: Studies by Yoo et al[ 18 ], Watamabe et al[ 19 ], Ahmed et al[ 20 ], Agrawal et al[ 15 ], and Correia et al[ 21 ] were considered low risk when globally assessed per outcome, while the studies by Khamaysi et al[ 16 ] and Weston et al[ 22 ] had some concerns, and the study by Riphaus et al[ 17 ] had a high risk of bias (Figure 2 ).…”

“…Recovery time: Six studies[ 15 - 18 , 20 , 22 ] with a total of 363 patients (191 in the propofol group and 172 in the midazolam group) reported recovery time after sedation. The recovery time was significantly higher in the midazolam group (MD: -8.19, 95%CI: -10.59 to -5.79, P < 0.00001) (Figure 5 ).…”

“…Discharge time: Three studies[ 16 , 20 , 22 ] with a total of 181 patients (91 in the propofol group and 90 in the midazolam group) reported discharge time after sedation. The discharge was significantly lower in the propofol group compared to midazolam (MD: -12.98, 95%CI: -18.46 to -7.50, P < 0.00001) (Figure 6 ).…”

“…Seven RCTs were included[ 15 - 17 , 19 - 22 ] in our analysis for procedure time, and we found no statistical difference between midazolam and propofol. Five diagnostic and therapeutic procedures studies[ 15 - 17 , 20 , 22 ] showed shorter procedure tie for the midazolam group; however, 2 RCTs[ 19 , 21 ], including therapeutic procedures, showed shorter procedure time for the propofol group. The study by Agrawal et al[ 15 ] also included patients without any sedation and showed a shorter procedure time in the sedation group, likely due to a reduction in the discomfort that patients felt during endoscopy without sedation.…”