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临床试验/NCT02058485
NCT02058485已完成3 期

Does the Use of Dexmedetomidine for Premedication Provide Hemodynamic Stability in Hypertensive Patients?

Duzce University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
162
试验地点
1
主要终点
peroperative hemodynamic changes

研究概览

简要总结

Hypertensive patients' often severe hypotensive response after induction of anesthesia and excessive increase in blood pressure to stresses such as laryngoscopy, intubation, surgical incision and extubation. There are many publications in the literature of preoperative evaluation of patients with hypertension and perioperative treatment of hypertension but is not sufficient about anesthetic management of these patients. Purpose of our study, was to investigate the haemodynamic effects of dexmedetomidine and midazolam used for premedication in hypertensive patients relative to each other and according to the normotensive patients.

详细描述

A total of 140 female patients, aged 40-60, normotensive or stage 1-2 hypertensive, scheduled for myomectomy or hysterectomy were randomly enrolled to 4 groups: Group ND (normotensive-dexmedetomidine); Group HD (hypertensive-dexmedetomidine); group NM (normotensive-midazolam); Group HM (hypertensive- midazolam). Twenty-one patients were excluded. The study drugs were administered 15 min before induction of anesthesia via intravenous infusion. Group ND (N= 29) received dexmedetomidine 0.5 µg.kg-1 in normotensive patient; Group HD (N= 30) received dexmedetomidine 0.5 µg.kg-1 in hypertensive patient; group NM (N= 30) received midazolam 0.025 mg. kg-1 in normotensive patient; Group HM (N= 30) received midazolam 0.025 mg. kg-1 in hypertensive patient. The study drugs was prepared by the anesthetist not included in the study in unlabeled syringes that determined by computer according to the group. The investigators and attending anesthesiologists were blinded to the randomization. Monitoring devices included noninvasive arterial blood pressure, electrocardiography, capnography, pulse oximetry and bispectral index.

For induction of anesthesia with fentanyl 1 µg. kg-1 IV and propofol infusion was in the presence of BIS monitoring. Propofol infusion was stopped when BIS value was 60. Endotracheal intubation was performed after rocuronium 0.6 mg. kg-1 iv administered, Anesthesia was maintained with sevoflurane in air/oxygen 50:50 mixture, titrated to achieve a BIS value between 40 and 60. If the MBP value was increased > 25% of the baseline value on two consecutive readings within 2-3 min, antihypertensive therapy was administered (nitroglycerine 5 µg.min-1 iv infusion) after excluded possible cause ( inadequate anesthesia, hypoxia, hypercapnia etc). Bradycardia ( HR< 45 beat/min) persisting for > 2 min was treated with atropine 0.5 mg IV, boluses. At the end of the surgery sevoflurane turned off, and 100% oxygen was administered. Tramadol 1 mg.kg-1 IV was administered for postoperative pain control. Neuromuscular block was antagonized with neostigmine (0.04 mg.kg-1 IV) and atropine (0.01 mg.kg-1 IV). Tracheal extubation was performed when obeying simple commands (open eye, squeeze hand etc) Systolic blood pressure (SBP), diastolic blood pressure ( DBP), mean blood pressure ( MBP) and heart rate ( HR) were recorded at several times as follows: baseline (T0 ), 5 minutes after administration of study drugs (T1), 10 minutes after administration of study drugs (T2), immediately after induction (T3), 1 minute after intubation (T4), 5 minute after intubation (T5), at surgical incision (T6), 15 minutes after surgical incision (T7), 30 minutes after surgical incision (T8), 1 minute after extubation (T9), 5 minute after extubation (T10). Propofol amount for induction, time between induction and initial surgery, demand of antihypertensive therapy, rescue atropine were recorded. Side effects (bradycardia, dryness of the mouth, respiratory depression) were evaluated.

The group sizes (N= 30) were calculated to detect a 25% changes in MBP value with a power of 80% and a significance level of 0.05. Quantitative clinical and demographic characteristics were compared using One Way ANOVA. Chi-square tests (Likelihood ratio or Pearson) were used to examine the relationships between categorical demographic data and groups. Baseline measurements of hemodynamic parameters showed significant differences between groups for the initial values of the measurement period values have been adjusted by subtracting the beginning. The values obtained after the correction in respect of groups were compared using one-way analysis of variance. In addition, perioperative use of antihypertensive drugs that affect the measurements were evaluated by analysis of co-variance, but there is not significant effect was removed from the model. Additionally periodic variations were examined by One way Repeated Measures Analysis of Variance for groups separately, and a significance level of 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Normotensive
  • Hypertension with stage 1 or 2
  • Scheduled for myomectomy or hysterectomy operation
  • Aged 40-60
  • ASA I or II
  • BMI is under 30 kg/m2

排除标准

  • Untreated hypertension
  • Users of ACE inhibitors as antihypertensive therapy
  • History of severe cardiovascular disease, renal disease, diabetes mellitus, cerebrovascular disease
  • An allergy to study drugs
  • Difficult airway
  • If the time more than fifteen minutes between the start of surgery and the induction
  • If necessary blood transfusion was required

研究组 & 干预措施

Group HD

Active Comparator

Dexmedetomidine was administered 0.5 µg.kg-1 in hypertensive patient

干预措施: Dexmedetomidine (Drug)

Group ND

Sham Comparator

Dexmedetomidine was administered 0.5 µg.kg-1 in normotensive patient

干预措施: Dexmedetomidine (Drug)

Group HM

Active Comparator

Midazolam was administered 0.025 mg. kg-1 in hypertensive patient.

干预措施: Midazolam (Drug)

Group NM

Sham Comparator

Midazolam was administered 0.025 mg. kg-1 in normotensive patient.

干预措施: Midazolam (Drug)

结局指标

主要结局

peroperative hemodynamic changes

时间窗: 2 hours

Systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate were recorded at baseline ( T0),5 minutes after administration of study drugs (T1), 10 minutes after administration of study drugs (T2), immediately after induction (T3), 1 minute after intubation (T4), 5 minute after intubation (T5), at surgical incision (T6), 15 minutes after surgical incision (T7), 30 minutes after surgical incision (T8), 1 minute after extubation (T9), 5 minute after extubation (T10).

次要结局

  • antihypertensive requirements(2 hours)

研究者

发起方
Duzce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

gulbin sezen

assistant of professor

Duzce University

研究点 (1)

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