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

ABSTRACT: BACKGROUND:Midazolam premedication is widely used before general anesthesia, but lacks clinical evidence of effectiveness. The present study aimed to evaluate the effectiveness of midazolam premedication following 4 aspects: anxiety reduction, sedation, hemodynamic stabilization, and analgesia. METHODS:In a randomized, single-blind, prospective study, a total of 128 women were allocated to the midazolam premedication group (Group P, n?=?64) or the control group (Group N, n?=?64). The patients were asked to complete the Beck anxiety inventory (BAI) 2 times: on the day before surgery (BS) and 30?minutes after midazolam premedication (T0). Depth of anesthesia using state entropy (SE), conventional hemodynamic data using heart rate (HR) and mean blood pressure (MBP), and analgesic profiles using surgical pleth index (SPI) were acquired at the following 4 points: T1-pre-induction, T2-prior to intubation, T3-intubation, and T4-20?minutes after intubation. RESULTS:No change in BAI score was observed between BS and T0 in both groups P and N (median and interquartile range [IQR], Group P: BS-4.5 [2.0-7.0], T0-4.0 [1.0-9.0], P?=?.603; Group N: BS-4.0 [1.0-8.5], T0-3.5 [1.0-6.0], P?=?.066). Midazolam premedication reduced SE at T2-4 (mean difference with 95% confidence interval [95% CI], T2-7.1 [1.6-12.6], P?=?.012; T3-10.4 [6.5-14.4], P?

SUBMITTER: Jeon S

PROVIDER: S-EPMC6393069 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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

Jeon Soeun S Lee Hyeon-Jeong HJ Do Wangseok W Kim Hae-Kyu HK Kwon Jae-Young JY Hwang Boo Young BY Yun Jihwan J

Medicine 20180801 35

<h4>Background</h4>Midazolam premedication is widely used before general anesthesia, but lacks clinical evidence of effectiveness. The present study aimed to evaluate the effectiveness of midazolam premedication following 4 aspects: anxiety reduction, sedation, hemodynamic stabilization, and analgesia.<h4>Methods</h4>In a randomized, single-blind, prospective study, a total of 128 women were allocated to the midazolam premedication group (Group P, n = 64) or the control group (Group N, n = 64). ...[more]

PMID: 30170468

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Project description:BackgroundSedative premedication with benzodiazepines has been linked with prolonged recovery and inadequate emergence during the immediate postoperative period. We aimed to analyze the association between postanesthesia care unit (PACU) delirium and sedative premedication with oral midazolam.MethodsWe performed a secondary analysis of prospectively collected data before (midazolam cohort) and after (non-midazolam cohort) implementation of a restrictive strategy for oral premedication with midazolam. From March 2015 until July 2018, we included patients 60 years and older, who underwent elective radical prostatectomy for prostate cancer. Exclusion criteria were contraindications to premedication with midazolam, preoperative anxiety, and a history of neurological disorders. Patients, who were scheduled for postoperative admission to the intensive care unit, were excluded. Between 2015 and 2016, patients received 7.5 mg oral midazolam preoperatively (midazolam cohort). Patients included between 2017 and 2018 did not receive any sedative medication preoperatively (non-midazolam cohort). The primary endpoint was the incidence of PACU delirium.ResultsPACU delirium rates were 49% in the midazolam cohort (n = 214) and 33% in the non-midazolam cohort (n = 218). This difference was not statistically significant on multivariable logistic regression analysis (OR 0.847 [95% CI 0.164; 4.367]; P = 0.842). Age (OR 1.102 [95% CI 1.050; 1.156]; P < 0.001), the cumulative dose of sufentanil (OR 1.014 [95% CI 1.005; 1.024]; P = 0.005), and propofol-sufentanil for anesthesia maintenance (OR 2.805 [95% CI 1.497; 5.256]; P = 0.001) were significantly associated with PACU delirium.ConclusionMidazolam for sedative premedication was not significantly associated with PACU delirium. The reduction in the incidence of PACU delirium throughout the study period may be attributable to improvements in perioperative management other than a more restrictive preoperative benzodiazepine administration.

Project description:BackgroundMost patients experiencing preoperative anxiety would welcome support in coping with their anxiety. Anxiolytic medication is a common way to address preoperative anxiety. However, the proportion of patients who welcome anxiolytic medication preoperatively and the preferred time of taking it have not been studied thoroughly.MethodsAdult patients (n = 1000) scheduled to undergo elective surgery under general anesthesia were eligible to participate in this single-center observational study. Primary outcomes were the ratio of patients desiring anxiolytic medication (no/yes/on request) and the preferred time of taking it (evening before surgery/morning of day of surgery/on call to the operating room). Secondary outcomes included associations between different measures of anxiety (i.e., anxiety level according to the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and anxiety status (no/yes)) and desire for anxiolytic medication (no/yes/on request). Primary outcomes were analyzed descriptively, and secondary outcomes were analyzed using multinomial logistic regressions.ResultsThree hundred fifty-six (35.6%) out of 1000 patients desired anxiolytic medication and 239 (23.9%) patients would welcome anxiolytic medication on request. In patients reporting anxiety (no/yes; n = 493), 228 (46.2%) stated a clear desire for anxiolytic medication (yes) and 142 (28.8%) considered anxiolytic medication (on request). Patients' preferences concerning the timing of premedication vary widely. In patients reporting a clear desire for anxiolytic medication (n = 356), the "morning of the day of surgery" was most frequently (n = 111, 31.2%) stated as the preferred time to get anxiolytic medication, followed by "on call to the operating room" (n = 51, 14.3%). All anxiety measures were significantly associated with desire for anxiolytic medication (p < 0.05).ConclusionsGiven the importance of preoperative anxiety to patients, patients' desire for anxiolytic medication should be considered when discussing the pros and cons of premedication. Individualized instead of standardized prescription and timing of premedication is recommended.Trial registrationGerman Clinical Trials Register ( DRKS 00013319 , approved 23/11/2017).

Project description:BACKGROUND:Perioperative anxiety is common in pediatric patients undergoing surgery. AIMS:The aim of this study was to determine whether an infusion of dexmedetomidine prior to hernia repair in children provides better postoperative anxiety outcomes that a preoperative infusion of midazolam. METHODS:Ninety 6-11-year-old children, who were scheduled to undergo elective hernia repair, were enrolled for this double-blind, randomized controlled trial. Group D (n = 45) received an intravenous infusion of dexmedetomidine (0.5 ?g/kg) and Group M (n = 45) received an intravenous infusion of midazolam (0.08 mg/kg) in 20 mL of normal saline for 10 minutes before the induction of anesthesia. Pre- and postoperative scores on the modified Yale Preoperative Anxiety Scale were the main outcomes. Secondary outcomes included systolic blood pressure, diastolic blood pressure, heart rate, and postoperative pain measured on a visual analogue scale and patient satisfaction using a numerical rating scale. RESULTS:Postoperative anxiety in Group D was significantly lower than preoperative anxiety (2 hours postoperatively mean difference [95% CI]: 2.83 [0.87-4.79], P = 0.036, 4 hours postoperatively mean difference [95% CI]: 3.29 [1.39-5.20], P = 0.005). Preoperative and postoperative anxiety in Group M was similar. Anxiety scores in Group D were also significantly lower than anxiety in Group M 2 hours (mean difference [95% CI]: 1.89 [0.52-3.26], P = 0.01) and 4 hours (mean difference [95% CI]: 3.32 [1.98-4.66], P < 0.001) postoperatively. Systolic blood pressure, diastolic blood pressure and heart rate were lower in Group D than in Group M after administration of sedative drugs until children left PACU (SBP mean difference [95% CI]: 13.87 [10.30-17.43], P < 0.001, DBP mean difference [95% CI]: 5.96[3.80-8.11], P < 0.001, HR mean difference [95% CI]: 10.36 [7.58-13.13], P < 0.001). Pain was also significantly lower in Group D than in Group M at 2 hours (median difference [95% CI]: 1 [0.26-1.34], P = 0.004), 4 hours (median difference [95% CI]: 1 [0.31-1.02], P = 0.003), and 1 day (median difference [95% CI]: 0 [0.22-0.76], P = 0.003) postoperatively. Patient satisfaction scores were significantly higher in Group D than in Group M 1 day (median difference [95% CI]: 0 [-0.83 to -0.24], P = 0.006) and somewhat higher 1 week (median difference [95% CI]: 0 [-0.67 to -0.04], P = 0.06) postoperatively. CONCLUSION:Compared with midazolam, a single preoperative intravenous dose of dexmedetomidine appears to provide better postoperative anxiolytic effects for children undergoing same-day surgery.

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

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

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