Randomized controlled trial assessing the effectiveness of midazolam premedication as an anxiolytic, analgesic, sedative, and hemodynamic stabilizer

Jeon, Soeun; Lee, Hyeon-Jeong; Do, Wangseok; Kim, Hae-Kyu; Kwon, Jae‐Young; Hwang, Boo Young; Yun, Jihwan

doi:10.1097/md.0000000000012187

“…He evaluated the psychomotor function of patients who received diazepam and midazolam by digit symbol substitution test (DSST) that is sensitive to central nervous system disruption and revealed that the performance returned to baseline at 60 minutes after diazepam administration and was significantly improved over baseline at 120 minutes, but deterioration persisted at 90 minutes after midazolam administration and returned to baseline at 180 minutes. Also they compared the sensory motor performance, a critical determinant of recovery between patients who received diazepam and midazolam and did not show any significant difference at any of the time during and after operation [18,34]. In our study the level of sedation and surgeon's satisfaction was better in diazepam group compared to midazolam group.…”

Section: Discussionmentioning

confidence: 45%

Comparison of Effectiveness and Side Effects of Diazepam versus Midazolam Administration for Conscious Sedation in Patients Who Underwent Cataract Surgery

Sanatkar¹,

Shorooghi²,

Sanie³

2019

AACC

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Background: The purpose of this study was to compare the effectiveness and side effects of diazepam and midazolam administration for conscious sedation in subjects who undergoing cataract surgery. Methods: A total of 79 patients undergoing cataract surgery under topical anesthesia with conscious sedation were prospectively reviewed. Our subjects were randomly divided to two groups. The first group comprised of 38 cases receiving 0.05 mg/kg diazepam slow intravenously (diazepam group) and the second group comprised of 41 cases receiving 0.01 mg/kg midazolam intravenously (midazolam group). Intraoperative variables such as systolic and diastolic arterial pressure, heart rate, respiratory rate and blood oxygen saturation were recorded immediately before sedation, 5, 10 and 15 minutes after diazepam or midazolam administration. All patients were contacted 24 hours after the operation for any early postoperative complications. Results: The variability of systolic and diastolic blood pressure at 5, 10 and 15 minutes after sedation were statistically significantly higher in midazolam group compared to diazepam group. Six patients developed episodes of apnea during operation, two patients in diazepam and four patients in midazolam group. The surgeons’ satisfaction was more in diazepam group but not statistically significant. Need for additional dose of benzodiazepine was more in the midazolam group. Drowsiness and functional impairment during 24 hours after surgery were not significantly different between the two groups. Conclusion: Diazepam produces better perioperative hemodynamic profile, level of sedation and surgeon’s satisfaction and less occurrence of apnea compared to midazolam group in patients who underwent cataract surgery.

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“…Midazolam is a routinely used premedication in surgical patients not just in Germany [7]. It is mostly applied to alleviate preoperative anxiety [36], but some anaesthesiologists might also use benzodiazepine premedication for prevention of intraoperative awareness, induction of sedation, hemodynamic stabilisation, and analgesia [7]. However, there is no medical evidence that benzodiazepine premedication is advantageous for all patients, especially the elderly ones.…”

Section: Discussionmentioning

confidence: 99%

“…Recent data in younger patients showed that there is an urge to reconsider the purpose of midazolam premedication [7]. Dose-dependent sedation up to respiratory depression and decreased blood pressure are possible [7]. Further, paradox reactions and the antegrade amnesia are experienced as unpleasant by some patients [8,9].…”

Section: Introductionmentioning

confidence: 99%

Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial

Kowark

¹

,

Rossaint

²

,

Keszei

³

et al. 2019

Preprint

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Introduction Premedication with benzodiazepines in surgical patients became questionable regarding risk-benefit ratio and lack of evidence. Though, preoperative benzodiazepines might alleviate preoperative anxiety, a higher risk for adverse events is described, particularly for elderly patients (≥65 years). Several German hospitals already withhold benzodiazepine premedication from elderly patients, though evidence is lacking. The patient-centred outcome global postoperative patient satisfaction is recognized as a substantial quality indicator of the anaesthesia care incorporated by the American Society of Anesthesiologists. Therefore, we aim to assess, whether the postoperative patient satisfaction after premedication with placebo compared to the preoperative administration of 3.75 mg midazolam in elderly patients differs. Methods This study is a multicentre, randomised, placebo-controlled, double-blinded, two-arm parallel, interventional trial, conducted in 9 German hospitals. In total 614 patients (≥65-80 years of age) undergoing elective surgery with general anaesthesia will be randomised to receive either 3.75 mg midazolam or placebo. The primary outcome (global patient satisfaction) will be assessed with the validated EVAN-G questionnaire on the first postoperative day. Secondary outcomes will be assessed until the first postoperative day and 30 days after surgery, respectively. They comprise among others: functional and cognitive recovery, postoperative delirium, health-related quality of life assessment, and mortality or new-onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury. Analysis will adhere to the intention-to-treat principle. The primary outcome will be analysed with the use of mixed linear model including treatment effect and study centre as factors and random effects for blocks. Exploratory adjusted and subgroup analyses of the primary and secondary outcomes with regard to gender effects, frailty, pre-operative anxiety level, patient demographics and surgery experience will be performed in addition. Discussion This, to the best of our knowledge, is the first study analyzing patient satisfaction after premedication with midazolam in elderly patients. In conclusion, this study will provide high quality data for decision-making process regarding premedication in the elderly surgical patients.

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“…Provision of comprehensive preoperative information and patient involvement in the decision-making process are some important strategies for preoperative reduction of anxiety levels [6]. The effect of benzodiazepines to reduce preoperative anxiety remains controversial [7]. Therefore, the indiscriminate necessity of benzodiazepine premedication is questionable in regard to the risk-benefit assessment.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, the indiscriminate necessity of benzodiazepine premedication is questionable in regard to the risk-benefit assessment. Recent data in younger patients showed that there is an urge to reconsider the purpose of midazolam premedication [7]. Dose-dependent sedation up to respiratory depression and decreased blood pressure are possible [7].…”

Section: Introductionmentioning

confidence: 99%

Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial

Kowark

¹

,

Rossaint

²

,

Keszei

³

et al. 2019

Preprint

View full text Add to dashboard Cite

Introduction Premedication with benzodiazepines in surgical patients became questionable regarding risk-benefit ratio and lack of evidence. Though, preoperative benzodiazepines might alleviate preoperative anxiety, a higher risk for adverse events is described, particularly for elderly patients (≥65 years). Several German hospitals already withhold benzodiazepine premedication from elderly patients, though evidence is lacking. The patient-centred outcome global postoperative patient satisfaction is recognized as a substantial quality indicator of the anaesthesia care incorporated by the American Society of Anesthesiologists. Therefore, we aim to assess, whether the postoperative patient satisfaction after premedication with placebo compared to the preoperative administration of 3.75 mg midazolam in elderly patients differs. Methods This study is a multicentre, randomised, placebo-controlled, double-blinded, two-arm parallel, interventional trial, conducted in 9 German hospitals. In total 614 patients (≥65-80 years of age) undergoing elective surgery with general anaesthesia will be randomised to receive either 3.75 mg midazolam or placebo. The primary outcome (global patient satisfaction) will be assessed with the validated EVAN-G questionnaire on the first postoperative day. Secondary outcomes will be assessed until the first postoperative day and 30 days after surgery, respectively. They comprise among others: functional and cognitive recovery, postoperative delirium, health-related quality of life assessment, and mortality or new-onset of serious cardiac or pulmonary complications, acute stroke, or acute kidney injury. Analysis will adhere to the intention-to-treat principle. The primary outcome will be analysed with the use of mixed linear model including treatment effect and study centre as factors and random effects for blocks. Exploratory adjusted and subgroup analyses of the primary and secondary outcomes with regard to gender effects, frailty, pre-operative anxiety level, patient demographics and surgery experience will be performed in addition. Discussion This, to the best of our knowledge, is the first study analyzing patient satisfaction after premedication with midazolam in elderly patients. In conclusion, this study will provide high quality data for decision-making process regarding premedication in the elderly surgical patients.

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Randomized controlled trial assessing the effectiveness of midazolam premedication as an anxiolytic, analgesic, sedative, and hemodynamic stabilizer

Abstract: Midazolam premedication did not reduce the level of anxiety. However, midazolam premedication reduced the entropy values, stabilized hemodynamics, and provided analgesia during the induction of anesthesia. The purpose of midazolam premedication needs to be reconsidered.

Cited by 19 publications

References 32 publications

Comparison of Effectiveness and Side Effects of Diazepam versus Midazolam Administration for Conscious Sedation in Patients Who Underwent Cataract Surgery

Comparison of Effectiveness and Side Effects of Diazepam versus Midazolam Administration for Conscious Sedation in Patients Who Underwent Cataract Surgery

Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial

Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial

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