Outcomes after endoscopic retrograde cholangiopancreatography with general anaesthesia versus sedation
Friederike C. AlthoffAbhishek AgnihotriStephanie D. GrabitzPeter SanterSarah NabelTuyet TranTyler M. BerzinEswar SundarXinling XuMandeep S. SawhneyMatthias Eikermann
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Background: Preservation of sedation is vital and of great significance to successfully carry out diagnostic-therapeutic procedures in children and researchers believe that it is indispensable to offer a safe medication with appropriate administration in this regard. Hence, the present study aimed at evaluating the efficacy of different doses of submucosal Midazolam to induce sedation in children undergoing diagnostic procedures. Methods: The present study was a clinical trial, in which 99 patients undergoing diagnostic procedures within the age range of 3 months to 5 years were selected and divided into three groups (n=33) of receiving submucosal Midazolam administration with doses of 0.3, 0.4, and 0.5 mg/kg. Then, the onset time of sedation, level of sedation, and duration of drug action were recorded and compared among the three groups. Results: In the present study, the level of sedation 30 min after the administration of Midazolam 0.3 mg/kg with the mean value of 2.42±0.83 was significantly lower than that of Midazolam 0.4 and 0.5 mg/kg with the mean values of 3.51±0.62 and 3.36±0.60, respectively (p -value <0.001). However, two doses of 0.4 and 0.5 mg/kg did not differ significantly. Conclusion: The best sub-mucosal dosage of midazolam for sedation with the least complications for pediatric diagnostic procedures is 0.4mg/kg.
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Background: During the transesophageal echocardiography (TEE) procedure, as in many other diagnostic semi-invasive applications, moderate sedation is preferred over deep sedation. Rarely, patients who cannot tolerate moderate sedation may require deep sedation when difficulties are encountered during TEE probe insertion. Although many different methods have been tried for the TEE procedure in clinical practice, the most appropriate sedation method is still controversial. Aims and Objectives: We aimed to evaluate the clinical effects of three different sedoanalgesia methods consisting of midazolam, propofol, and midazolam-pethidine combination protocols applied for conscious sedation in the patients undergoing a TEE procedure, and to evaluate the patient and doctor satisfaction during the procedure. Materials and Methods: One-hundred twenty five patients who underwent TEE for diagnostic purposes in our hospital were included consecutively in our prospective randomized trial. The patients were divided into three groups as those who were administered midazolam (group M), propofol (group Pr), and midazolam-pethidine (group MPe) during the TEE procedure. Results: In the MPe group, both patient and doctor satisfaction were significantly higher than the two groups. The rate of difficulty in probe placement was lower in the Pr and MPe groups compared to the M group (P<0.05). Conclusion: In this study, it has been observed that conscious sedation with the combination of midazolam-pethidine was significantly advantageous in terms of patient and physician satisfaction compared to the use of only midazolam and only propofol.
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Background: An efficacious, reliable, and non-invasive route of administration for midazolam, a drug used for sedation and pre-anesthetic medication, would have obvious advantages. This study compares the sedation achieved by nebulized route and intravenous route as procedural sedation.Methods: A randomized double-blinded interventional study was designed to compare the effect of nebulized midazolam with intravenous midazolam as a sedative medication in 86 children undergoing imaging procedures like CT scan, MRI scan, EEG. Ramsay sedation scores and parameters of cardiovascular and respiratory function were measured over 20 min and summarized Results: The mean sedation score in both groups was comparable at baseline, 10 minutes and 20 minutes with p values of 0.1, 0.1, 0.09 respectively. Parameters of cardiovascular and respiratory function were comparable in both the groups. Conclusion: Present study showed that nebulized midazolam when given at a higher dose of 1 mg/kg was found to be as potent as intravenous midazolam, opening up a door for a sedative which is easier to administer, has better acceptance with lesser complication.
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Objective To study the anterograde amnesia caused by midazolam which was used by patient-controlled sedation and anesthetist-controlled sedation.Methods 120 patients in surgical patients were divided ran-domly into two groups,60 patients in each.P group:patient-controlled sedation with midazolam;A group:anesthetist-controlled sedation with midazolam.Atropine 0.5mg was injected 30rain before operation,explaining the correct appli-cation of PCA pump to patients when we interview them.HR,ECG,BP,SPO2 were monitored during anesthesia.P group:midazolam 20mg+normal saline(NS) to 100mL,midazolam loding dose 0.02mg.kg-1,continous rates 0.001mg.kg-1.h-1,PCS 0.02mg.kg-1,lockout time 3min,PCS rates 30 seconds.A group:midazolam loding dose 0.02 mL.kg-1,continue rate 0.001mg.kg-1.h-1,Ramsay sedation score was used to evaluate the sedative depth every 10 minutes,appropriate sedative depth(Ramsay sedation score 4) kept by adjusting the infusion rate.Showing patients three pictures before sedation started,and checking patient memory at 12h after operation.Accessing the patient’s satisfaction degree by VAS score.Results The amount of midazolam was a little higher in P group(10±4)mg,than that in A group(9±3) mg,but there was no significant difference(P0.05).Postoperative anterograde amnesia existed in both two groups,memorability has no significant difference between two groups(P0.05),and there was a statistic difference between two groups [P group(89 ± 6) and A group(71 ± 8)] in patient satisfaction degree(P0.001).Conclusion Satisfactory anterograde amnesia occurred in both PCS group and ACS group.Patient preferred PCS.
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Background and objective No consensus exists for the safest and most effective agent and for optimal drug doses for sedation during endoscopic retrograde cholangiopancreatography (ERCP). We aimed to compare the efficacy of midazolam with that of midazolam+meperidine, which provided comfort for the patient during ERCP. Materials and methods The patients were randomized to sedation with midazolam only (2.87±0.67 mg) (n=48, median age 55.54±14.66, 21 women, 27 men) or midazolam (1.82±0.71 mg) with meperidine (42.81±14.61 mg) (n= 48, median age 55.48±2.57, 20 women, 28 men). Procedure-related parameters and the efficacy of sedation as assessed by the endoscopist and the patients were compared. Results Prior endoscopic history, preprocedure anxiety scores, age, sex, baseline vital signs and type of interventions were similar in both groups. Sedation level, duration of procedure and recovery time were comparable in both groups. Sedation quality assessment scale was significantly higher in the midazolam with meperidine group. Degree of pain sensed during the procedure was significantly lower in the midazolam with meperidine group. Midazolam with meperidine group had better patient satisfaction. Twenty-four hours after the procedure, the degree of amnesia between both sedation groups was similar. The number of patients unwilling to repeat the procedure was distinctly higher in midazolam group. Development of hypoxia and arrythmia in the midazolam and midazolam with meperidine groups were comparable. Two patients in the midazolam group developed paradoxical agitation. Conclusions Conscious sedation for ERCP can be successfully and safely achieved by using either only midazolam or a low dose of midazolam with meperidine. Adding of meperidine to midazolam resulted in better patient and endoscopist comfort.
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We studied midazolam plasma concentrations in patients undergoing middle ear surgery (MES) in local anesthesia and sedation. This study was based on the clinical measurement of the level of sedation and determination of the sedation dose of midazolam. For optimal level of sedation for this type of surgery we suggest the midazolam plasma concentrations with median of 0.03 mg L-1 and range from 0.01-0.10 mg L-1. This can be contrasted to the other studies where considerably higher plasma concentrations of midazolam (0.2 mg L-1) were proposed (S. Michalk et al., Intens. Care Med. 1988, 15, 37-41). Despite low midazolam concentrations the level of sedation was adequate.
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Purpose: The primary aim of this study was to evaluate whether differences exist in patient satisfaction between groups receiving fentanyl/midazolam and those receiving meperidine/midazolam for general endoscopy conscious sedation. Methods: In this prospective study, answers to the 20 question Patient Satisfaction with Sedation Instrument (PSSI) were collected from 198 patients who received either fentanyl/midazolam (N=91) or meperidine/midazolam (N=107) during endoscopy. The total score, sedation delivery subscale score, procedure recall subscale score, sedation side effects subscale score, and global satisfaction subscale score were calculated according to the PSSI guidelines, where higher scores indicate increased satisfaction. Patient characteristics and endoscopy information were compared between fentanyl/midazolam and meperidine/midazolam groups using Fisher's exact test or a Wilcoxon rank sum test. Results: The distribution of patient age, gender, and interventions were relatively similar between fentanyl/midazolam and meperidine/midazolam groups. There were two significant differences in PSSI responses between the two groups. Patients in the meperidine/midazolam group were more often “very satisfied” with the length of time they felt the effects of the sedation (77% vs. 65%, P=0.048). Also, patients in the meperidine/midazolam group responded “very satisfied” more often regarding how they would compare their satisfaction with this experience to their previous experience with endoscopy (86% vs. 71%, P=0.014). In the PSSI subscale scores between the two sedation groups, results were similar except for the sedation delivery subscale score, which was significantly higher in meperidine/midazolam patients compared to fentanyl/midazolam patients (P=0.034). The sedation delivery subscale score incorporated several questions including ease of medication administration and pain associated with delivery. Conclusion: In this prospective study, we utilized the PSSI, which has previously been externally validated, to compare patient satisfaction with sedation between two groups who received commonly administered regimens. We observed that patients were overall satisfied with sedation in both groups. However, there were several questions for which patients who received meperidine/midazolam were more satisfied than patients who received fentanyl/midazolam, where differences either reached statistical significance or trended toward significance.
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