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临床试验/NCT01404442
NCT01404442已完成1 期

Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section

Qazvin University Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
Time to first requirement of analgesic supplement

研究概览

简要总结

Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section .

Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)<90], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS >4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.

详细描述

The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section

排除标准

  • significant coexisting disease such as hepato-renal and cardiovascular disease
  • any contraindication to regional anesthesia such as local infection or bleeding disorders
  • allergy to ketamine or midazolam
  • long-term opioid use or a history of chronic pain.

研究组 & 干预措施

Ketamine

Active Comparator

The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally .

干预措施: Ketamine (Drug)

midazolam

Active Comparator

The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally

干预措施: Midazolam (Drug)

placebo

Placebo Comparator

The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

干预措施: placebo(distilled water (Drug)

结局指标

主要结局

Time to first requirement of analgesic supplement

时间窗: participants will be followed for the duration of 24 hours after intratechal injection (Time from the injection of intrathecal anesthetic solution to first requirement of analgesic supplement will be recorded.)

analgesic administration was initiated by patient request(verbal rating scale\[ VRS\]\>4)

Postoperative analgesic requirements

时间窗: 24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)

postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS\>4)

次要结局

  • Sensory block onset time will be assessed by a pinprick test(sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection)
  • duration of sensory block will be assessed by a pinprick test(sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection)
  • the onset of motor block will be assessed by the modified Bromage score(every10 seconds following intrathecal injection)
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring(30 minutes after intrathecal injection)
  • duration of motor block will be assessed by the modified Bromage score(every 5 minutes following intrathecal injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

marzieh beigom khezri

Assistant professor

Qazvin University Of Medical Sciences

研究点 (1)

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