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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.

SUBMITTER: Ahmed SA

PROVIDER: S-EPMC5634622 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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

Ahmed Sameh Abdelkhalik SA Selim Amal A Hawash Nehad N Tawfik Ahmed Khaled AK Yousef Mohamed M Kobtan Abdelrahman A Badawi Rehab R Elnawasany Sally S Elkhouly Reham Abdelkader RA Hanafy Amr Shaaban AS Rizk Fatma H FH Mansour Loai L Abd-Elsalam Sherief S

International journal of hepatology 20170926

<h4>Objectives</h4>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.<h4>Methods</h4>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, ...[more]

PMID: 29312786

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Project description:IntroductionDexmedetomidine was shown in two European randomized double-blind double-dummy trials (PRODEX and MIDEX) to be non-inferior to propofol and midazolam in maintaining target sedation levels in mechanically ventilated intensive care unit (ICU) patients. Additionally, dexmedetomidine shortened the time to extubation versus both standard sedatives, suggesting that it may reduce ICU resource needs and thus lower ICU costs. Considering resource utilization data from these two trials, we performed a secondary, cost-minimization analysis assessing the economics of dexmedetomidine versus standard care sedation.MethodsThe total ICU costs associated with each study sedative were calculated on the basis of total study sedative consumption and the number of days patients remained intubated, required non-invasive ventilation, or required ICU care without mechanical ventilation. The daily unit costs for these three consecutive ICU periods were set to decline toward discharge, reflecting the observed reduction in mean daily Therapeutic Intervention Scoring System (TISS) points between the periods. A number of additional sensitivity analyses were performed, including one in which the total ICU costs were based on the cumulative sum of daily TISS points over the ICU period, and two further scenarios, with declining direct variable daily costs only.ResultsBased on pooled data from both trials, sedation with dexmedetomidine resulted in lower total ICU costs than using the standard sedatives, with a difference of €2,656 in the median (interquartile range) total ICU costs-€11,864 (€7,070 to €23,457) versus €14,520 (€7,871 to €26,254)-and €1,649 in the mean total ICU costs. The median (mean) total ICU costs with dexmedetomidine compared with those of propofol or midazolam were €1,292 (€747) and €3,573 (€2,536) lower, respectively. The result was robust, indicating lower costs with dexmedetomidine in all sensitivity analyses, including those in which only direct variable ICU costs were considered. The likelihood of dexmedetomidine resulting in lower total ICU costs compared with pooled standard care was 91.0% (72.4% versus propofol and 98.0% versus midazolam).ConclusionsFrom an economic point of view, dexmedetomidine appears to be a preferable option compared with standard sedatives for providing light to moderate ICU sedation exceeding 24 hours. The savings potential results primarily from shorter time to extubation.Trial registrationClinicalTrials.gov NCT00479661 (PRODEX), NCT00481312 (MIDEX).

Project description:BackgroundPatients in the intensive care unit (ICU) are often under stress and fail to cooperate well with invasive treatments. Analgesia and sedation are of great significance for reducing the suffering of patients and ensuring the application and effectiveness of treatment. For better clinical choice, we aimed to explore the effect of the combination of propofol + fentanyl or midazolam + fentanyl on the short-term prognosis of hospitalized patients in the ICU.MethodsAccording to the inclusion and exclusion criteria, we retrospectively included patients in the MIMIC-IV database receiving midazolam + fentanyl or propofol + fentanyl analgesic and sedative treatment using Structured Query Language (SQL) to extract clinical data from the MIMIC-IV database. The primary endpoint was the death rate within 28 days after the patient was admitted to the ICU. Doubly robust estimation was used to infer the relationship between sedation and analgesia and 28 days outcome. The gradient boosted model (GBM) was used to estimate the propensity score (PS) of the patient's sedation and analgesia program, PS was used as the weight, and the inverse probabilities weighting (IPW) model was used to generate a weighted cohort.ResultsIn total, 4,188 cases were included, with 2,174 (51.9%) in the propofol group and 2,014 (48.1%) in the midazolam group. In the PS score matching cohort, the 28-day mortality of patients in the midazolam group was 30.8%, and the 28-day mortality of patients in the propofol group was 25.5%. The adjusted odds ratio (OR) value was 1.421 [95% confidence interval (CI): 1.118-1.806, P<0.001]. Patients in the propofol group did not use vasoactive drugs for a longer period of time than the midazolam group, and patients in the propofol group received significantly more fluids than those in the midazolam group in the first three days after admission to the ICU.ConclusionsCompared with midazolam combined with fentanyl, propofol combined with fentanyl for sedation and analgesia can reduce the risk of short-term death in ICU patients.

Dataset Information

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

Publications

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

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