Dataset Information

Propofol Alone versus Propofol in Combination with Midazolam for Sedative Endoscopy in Patients with Paradoxical Reactions to Midazolam.

ABSTRACT:

Background/aims

The efficacy of propofol in gastrointestinal endoscopy for patients with midazolam-induced paradoxical reactions remains unclarified. This study aimed to compare the efficacy and safety of propofol-based sedation in patients who previously experienced paradoxical reactions.

Methods

This was a prospective, single-blinded, randomized controlled pilot study. Participants with a history of paradoxical reactions to midazolam during a previous esophagogastroduodenoscopy were recruited and randomly assigned to group I (propofol monosedation) or group II (combination of propofol and midazolam). The primary endpoint was the occurrence of a paradoxical reaction.

Results

A total of 30 participants (mean age, 54.7±12.6 years; male, 19/30) were randomly assigned to group I (n=16) or group II (n=14). There were no paradoxical reactions in group I, but there were two in group II, without a significant difference (p=0.209). The mean dose of propofol was higher in group I than in group II (p=0.002). Meanwhile, the procedure and recovery times did not differ between groups.

Conclusion

Propofol-based sedation was safe and effective for patients who experienced paradoxical reactions to midazolam. However, caution is needed because few cases of paradoxical reaction again can happen in group II in which midazolam was readministered.

SUBMITTER: Nam JH

PROVIDER: S-EPMC8995981 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Publications

Propofol Alone versus Propofol in Combination with Midazolam for Sedative Endoscopy in Patients with Paradoxical Reactions to Midazolam.

Nam Ji Hyung JH Jang Dong Kee DK Lee Jun Kyu JK Kang Hyoun Woo HW Kim Byung-Wook BW Jang Byung Ik BI

Clinical endoscopy 20211012 2

<h4>Background/aims</h4>The efficacy of propofol in gastrointestinal endoscopy for patients with midazolam-induced paradoxical reactions remains unclarified. This study aimed to compare the efficacy and safety of propofol-based sedation in patients who previously experienced paradoxical reactions.<h4>Methods</h4>This was a prospective, single-blinded, randomized controlled pilot study. Participants with a history of paradoxical reactions to midazolam during a previous esophagogastroduodenoscopy ...[more]

PMID: 34634857

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Project description:BackgroundBronchoscopy can be a distress for the patient. There have been few studies on the combination of sedatives and opioids. The aim of this study was to demonstrate the usefulness and safety of administration of the combination of midazolam and pethidine during bronchoscopy.MethodsIn this prospective randomized single (patient)-blind study, we randomly assigned 100 patients who were scheduled to undergo bronchoscopy biopsy to receive treatment with either the midazolam/pethidine combination (combination group) or midazolam alone (midazolam group) during examinations. After the end of bronchoscopy, patients completed a questionnaire and the visual analogue scale was measured. The primary outcome was the patients' acceptance of re-examination assessed by visual analogue scale. We also assessed pain levels, vital signs, midazolam use, xylocaine use, and adverse events. Univariate analyses were performed using Fisher's exact test for categorical data, and the t-test or Mann-Whitney test was carried out for analysis of numeric data. All P-values were two-sided, and values < 0.05 were considered statistically significant.ResultsWe analyzed 47 patients in the combination group and 49 patients in the midazolam group. The primary outcome was a good trend in the combination group, but not significantly different (3.82 ± 2.3 in combination group versus 4.17 ± 2.75 in midazolam alone, P = 0.400). In the combination group, the visual analog scale score for pain during bronchoscopy was significantly lower (1.10 ± 1.88 versus 2.13 ± 2.42, P = 0.022), and the sedation level score per the modified observer's assessment of alertness/sedation scale was significantly deeper (3.49 ± 0.98 versus 3.94 ± 1.03, P = 0.031). Maximal systolic blood pressure during testing was significantly lower (162.39 ± 23.45 mmHg versus 178.24 ± 30.24 mmHg, P = 0.005), and the number of additional administrations of midazolam was significantly lower (2.06 ± 1.45 versus 2.63 ± 1.35, P = 0.049). There were also significantly fewer adverse events (30 versus 41, P = 0.036).ConclusionsThe combination uses of midazolam and pethidine for sedation resulted in significant improvements in the pain, blood pressure, additional use of midazolam, and safety during bronchoscopy among patients.Trial registrationThis study was registered in the University Medical Hospital Information Network in Japan (UMINCTR Registration number: UMIN000032230 , Registered: 13/April/2018).

Project description:BackgroundPropofol and midazolam are commonly used sedative drugs in mechanically ventilated patients in the Intensive Care Unit (ICU). However, there is still a lack of relevant studies exploring the influence of midazolam and propofol on the prognosis of patients with Sepsis-associated Acute Kidney Injury (S-AKI).Patients and methodsA statistical analysis was conducted on 3,745 patients with S-AKI in the Medical Information Mart for Intensive Care IV database. The patients' baseline characteristics were grouped based on the use of either propofol or midazolam as sedatives. Cox proportional hazards models, logistic regression models, and subgroup analyses were used to compare the effects of propofol and midazolam on the short-term prognosis of S-AKI patients, including 30-day mortality, ICU mortality, and duration of mechanical ventilation.ResultsIn the statistical analysis, a total of 3,745 patients were included, with 649 patients using midazolam and 3,096 patients using propofol. In terms of the 30-day mortality, compared to patients using midazolam, S-AKI patients using propofol had a lower ICU mortality (hazard ratio = 0.62, 95% confidence interval: 0.52-0.74, p < 0.001), lower 30-day mortality (hazard ratio = 0.56, 95% confidence interval: 0.47-0.67, p < 0.001), and shorter mechanical ventilation time (odds ratio = 0.72, 95% confidence interval: 0.59-0.88, p < 0.001). Kaplan-Meier curves showed lower survival probabilities in the midazolam group (p < 0.001). Subgroup analyses showed that propofol was strongly protective of short-term prognosis in older, male, smaller SOFA score CCI score, no heart failure, and comorbid chronic kidney disease patients with S-AKI.ConclusionCompared to midazolam, propofol was considered a protective factor for short-term mortality risk and ICU mortality risk in S-AKI patients. Additionally, S-AKI patients using propofol had a lower risk of requiring prolonged mechanical ventilation. Overall, propofol may be more beneficial for the short-term prognosis of S-AKI patients compared to midazolam.

Dataset Information

Propofol Alone versus Propofol in Combination with Midazolam for Sedative Endoscopy in Patients with Paradoxical Reactions to Midazolam.

Background/aims

Methods

Results

Conclusion

Publications

Propofol Alone versus Propofol in Combination with Midazolam for Sedative Endoscopy in Patients with Paradoxical Reactions to Midazolam.

Similar Datasets

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