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临床试验/NCT01880775
NCT01880775已完成4 期

The Comparison of the Discharge Conditions and Efficacy of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl in Outpatient Minor Perianal Surgery

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Sensory block regression at S3 (time, minute)

研究概览

简要总结

In this prospective randomized study the investigators aimed to investigate difference of the duration of spinal anesthesia, discharge times and efficacy between low dose heavy Prilocaine-Fentanyl and heavy Bupivacaine-Fentanyl in outpatient minor anal surgery.

详细描述

ASA status I-III patients will be recruited. Patients will be randomized in two groups. Group B will be received 1.5 ml heavy bupivacaine+ 20 mic fentanyl+ 0.15 ml and Group P will be received 1,5 ml heavy prilocaine+20 mic fentanyl in the same volume.Patients will be monitored with electrocardiography, peripheral oxygen saturation(sPO2) and non invasive blood pressure (Drager Infinity Delta; 16 Electronics Avenue, Danvers, MA 01923 USA). After inserting a 20 G intravenous line the patients will be hydrated with 10 ml/kg 0.9 % saline.

Preoperative systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR) and Spo2 will be measured and recorded.

Spinal anesthesia will be commenced in the sitting position with a 25 G Quincke needle, with the midline approach. After observing free flow of cerebrospinal fluid the prepared study drug will be injected in 15 seconds. The patients will be placed supine after waiting 2 minute in the sitting position. Supplemental oxygen via nasal cannula will be provided.

Fentanyl and midazolam will be used for rescue analgesia and sedation and recorded.

Sensorial block will be assessed with pinprick test with 2 minute intervals until the maximum block achieves and with 15 minute intervals until the block was regresses to S3 dermatome. Motor block will be assessed with the Bromage score when the block reached the maximum level. Patients will be transferred to postoperative care unit (PACU) at he end of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA status I-III

排除标准

  • Patients with contraindications for spinal anesthesia,
  • hypersensitivity to study drugs

研究组 & 干预措施

prilocaine heavy 2%& fentanyl

Experimental

prilocaine heavy 2% 30 mg and fentanyl 20 micgr ampoule intrathecal

干预措施: Prilocaine (Drug)

bupivacaine heavy 0.5% & fentanyl

Active Comparator

bupivacaine heavy 0.5% 7.5 mg and fentanyl 20 micg ampoule intrathecal

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Sensory block regression at S3 (time, minute)

时间窗: postoperative 30. minute

spinal anesthesia

次要结局

  • discharge time (minute)(postoperative 2 hour)

研究者

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

Ozden Gorgoz Kaban

Medical Doctor Trainee in Anesthesiology and Reanimation

Diskapi Teaching and Research Hospital

研究点 (1)

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