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Effects of midazolam or tramadol premedication on early cognitive function in endoscopic retrograde cholangiopancreatography (ERCP): A randomized, controlled, double-blind study.

ABSTRACT: To evaluate the sedative efficacy and effects on early period cognitive function of premedication in endoscopic retrograde cholangiopancreatography (ERCP).Forty patients (18-70 years; American Society of Anesthesiology risk category I-III) undergoing elective ERCP were randomized to receive oral premedication with 0.15?mg/kg midazolam or 1?mg/kg tramadol. Cognitive function was determined by mini-mental test (MMT). Target scores for effective sedation were determined as a Bispectral index score of 70-90 and modified Ramsay Sedation Scale score (mRSS) of 2-4.Global MMT score was not significantly different between treatment groups at 60?min post-ERCP. A significant deterioration in the MMT subcategory of recall was determined in with midazolam versus tramadol. Level of sedation (mRSS) was higher in with midazolam compared with tramadol reaching statistical significance at 30?min after drug administration.Although more effective sedation was obtained with midazolam in patients undergoing ERCP, there was a dysfunction in memory recall. It was concluded, however, that early cognitive functions were generally preserved with both drugs.

SUBMITTER: Ulusoy H

PROVIDER: S-EPMC5536697 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Effects of midazolam or tramadol premedication on early cognitive function in endoscopic retrograde cholangiopancreatography (ERCP): A randomized, controlled, double-blind study.

Ulusoy Hulya H Coskun Ilker I Arslan Mehmet M

The Journal of international medical research 20160304 3

<h4>Objective</h4>To evaluate the sedative efficacy and effects on early period cognitive function of premedication in endoscopic retrograde cholangiopancreatography (ERCP).<h4>Methods</h4>Forty patients (18-70 years; American Society of Anesthesiology risk category I-III) undergoing elective ERCP were randomized to receive oral premedication with 0.15 mg/kg midazolam or 1 mg/kg tramadol. Cognitive function was determined by mini-mental test (MMT). Target scores for effective sedation were deter ...[more]

PMID: 26944385

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Project description:Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) is technically challenging in patients with Roux-en-Y gastric bypass (RYGB) anatomy, which is increasing in frequency given the rise of obesity. Laparoscopy-assisted ERCP (LA-ERCP) and enteroscopy-assisted ERCP (EA-ERCP) are distinct approaches with their respective strengths and weaknesses. We conducted a meta-analysis comparing the procedural time, rates of success and adverse events of each method. Patients and methods A search of PubMed, EMBASE and the Cochrane library was performed from inception to October 2018 for studies reporting outcomes of LA or EA-ERCP in patients with RYGB anatomy. Studies using single, double, 'short' double-balloon or spiral enteroscopy were included in the EA-ERCP arm. Outcomes of interest included procedural time, papilla identification, papilla cannulation, therapeutic success and adverse events. Therapeutic success was defined as successful completion of the originally intended diagnostic or therapeutic indication for ERCP. Results A total of 3859 studies were initially identified using our search strategy, of which 26 studies met the inclusion criteria. The pooled rate of therapeutic success was significantly higher in LA-ERCP (97.9 %; 95 % CI: 96.7-98.7 %) with little heterogeneity (I 2 = 0.0 %) when compared to EA-ERCP (73.2 %; 95 % CI: 62.5-82.6 %) with significant heterogeneity (I 2 : 80.2 %). Conversely, the pooled rate of adverse events was significantly higher in LA-ERCP (19.0 %; 95 % CI: 12.6-26.4 %) when compared to EA-ERCP (6.5 %; 95% CI: 3.9-9.6 %). The pooled mean procedure time for LA-ERCP was 158.4 minutes (SD ± 20) which was also higher than the mean pooled procedure time for EA-ERCP at 100.5 minutes (SD ± 19.2). Conclusions LA-ERCP is significantly more effective than EA-ERCP in patients with RYGB but is associated with a higher rate of adverse events and longer procedural time.

Project description:GoalsWe aimed to assess outcomes of patients with liver cirrhosis who underwent therapeutic or diagnostic endoscopic retrograde cholangiopancreatography (ERCP) to determine whether these patients had different outcomes relative to patients without cirrhosis.BackgroundERCP is an important procedure for treatment of biliary and pancreatic disease. However, ERCP is relatively technically difficult to perform when compared with procedures such as esophagogastroduodenoscopy or colonoscopy. Little is known about how ERCP use affects patients with liver cirrhosis.StudyUsing patient records from the National Inpatient Sample (NIS) database, we identified adult patients who underwent ERCP between 2009 and 2014 using International Classification of Disease, Ninth Revision coding and stratified data into 2 groups: patients with liver cirrhosis and those without liver cirrhosis. We compared baseline characteristics and multiple outcomes between groups and compared outcomes of diagnostic versus therapeutic ERCP in patients with cirrhosis. A multivariate regression model was used to estimate the association of cirrhosis with ERCP outcomes.ResultsA total of 1,038,258 hospitalizations of patients who underwent ERCP between 2009 and 2014 were identified, of which 31,294 had cirrhosis and 994,681 did not have cirrhosis. Of the patients with cirrhosis, 21,835 (69.8%) received therapeutic ERCP and 9459 (30.2%) received diagnostic ERCP. Patients with cirrhosis had more ERCP-associated hemorrhages (2.5% vs. 1.2%; P <0.0001) compared with noncirrhosis patients but had lower incidence of perforations (0.1% vs. 0.2%; P <0.0001) and post-ERCP pancreatitis (8.6% vs. 7%; P <0.0001). Cholecystitis was the same between groups (2.3% vs. 2.3%; P <0.0001). In patients with cirrhosis, those who received therapeutic ERCP had higher post-ERCP pancreatitis (7.9% vs. 5.1%; P <0.0001) and ERCP-associated hemorrhage (2.7% vs. 2.1%; P <0.0001) but lower incidences of perforation and cholecystitis (0.1% vs. 0.3%; P <0.0001) and cholecystitis (1.9 vs. 3.1%; P <0.0001) compared with those who received diagnostic ERCP.ConclusionsUse of therapeutic ERCP in patients with liver cirrhosis may lead to higher risk of complications such as pancreatitis and postprocedure hemorrhage, whereas diagnostic ERCP may increase the risk of pancreatitis and cholecystitis in patients with cirrhosis. Comorbidities in cirrhosis patients may increase the risk of post-ERCP complications and mortality; therefore, use of ERCP in cirrhosis patients should be carefully considered, and further studies on this patient population are needed.

Project description:BackgroundAlthough rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients.MethodsIn this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete.FindingsBetween July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up.InterpretationDose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.FundingAmerican College of Gastroenterology.

Dataset Information

Effects of midazolam or tramadol premedication on early cognitive function in endoscopic retrograde cholangiopancreatography (ERCP): A randomized, controlled, double-blind study.

Publications

Effects of midazolam or tramadol premedication on early cognitive function in endoscopic retrograde cholangiopancreatography (ERCP): A randomized, controlled, double-blind study.

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