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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: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.

Project description:Perioperative hemodynamic fluctuations are seen more often in hypertensive patients than in normotensive patients. The purpose of our study was to investigate the perioperative hemodynamic effects of dexmedetomidine and midazolam used for premedication in hypertensive patients relative to each other and in comparison to normotensive patients.One-hundred-forty female, normotensive or hypertensive patients undergoing myomectomies or hysterectomies. They were randomly enrolled into the subgroups: Group ND (normotensive-dexmedetomidine); Group HD (hypertensive-dexmedetomine); Group NM (normotensive-midazolam); Group HM (hypertensive- midazolam). Dexmedetomidine was administered at a concentration of 0.5 ?g.kg(-1), and midazolam was administered at a concentration of 0.025 ?g.kg(-1) via intravenous (IV) infusion before the induction of anaesthesia. Haemodynamic parameters were recorded at several times (T(beginning), T(preop5 min), T(preop 10 min), T(induction), T(intubation), T(intubation 5 min), T(initial surgery), T(surgery 15 min), T(surgery 30 min), T(extubation), T(extubation 5 min)). Propofol amount for induction, time between induction and initial surgery, demand of antihypertensive therapy, rescue atropine were recorded. Quantitative clinical and demographic characteristics were compared using One Way ANOVA. The values were compared using One-way Analysis of Variance. Additionally periodic variations were examined by One way Repeated Measures Analysis of Variance for groups separately.SBP was significantly different between normotensive and hypertensive groups at the following time points: T(preop 5 min), T(preop 10 min), T(induction), T(intubation), T(intubation 5 min) and T(initial surgery). MBP was significantly different in the hypertensive groups at T(induction), T(intubation), T(intubation 5 min), T(initial surgery), T(surgery 15 min), T(surgery 30 min), T(extubation) and T(extubation 5 min). The perioperative requirements for antihypertensive drugs were significantly higher in Group HM.In the hypertensive patients, dexmedetomidine premedication provides better hemodynamic stability compared with midazolam, and because it decreases the antihypertensive requirements, its use might be beneficial.Clinicaltrials.gov identifier: NCT02058485.

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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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