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临床试验/NCT03424356
NCT03424356Unknown不适用

Comparison of Effects of Low Dose Neuromuscular Blocker Added to Propofol Fentanyl Combination During Lma Procedures in Cystoscopy Patients

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年1月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
96
试验地点
1
主要终点
questionnaire

研究概览

简要总结

Cystoscopy is a simple, effective and reliable method in current urological practice. Anesthesia may be required in cystoscopy for therapeutic purpose, however it may not be necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural anaesthesia and senile block methods may be performed in therapeutic cystoscopy.

Pain is main reason of failed cystoscopy. Sedo-analgesia and LMA are generally used for diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant administration in LMA placement, as it is necessary for intubation. However if muscle relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle movement, hypoxia and laryngeal spasm may be observed.

For the improvement of the patient comfort the use of effective muscle relaxants are described in several studies in literature. This study aimed to reveal the quality of anesthesia, hemodynamics, surgical comfort, extra propofol need and recovery time while low dose of muscle relaxant rocuronium was added to propofol-fentanyl combination for LMA placement.

详细描述

Cystoscopy is a simple, effective and reliable method in current urological practice for the diagnosis and treatment of urethral and bladder pathologies.

Procedure is frequently used for the placement and replacement (removal) of double J stent in patients with ureteral stones .

Cystoscopy may be used for the investigation of hematuria and dysuria and if needed for diagnostic biopsy as well as for therapeutic purpose in patients with bladder and prostate tumor.

Anesthesia may be required in cystoscopy for therapeutic purpose, however it may not be necessary for diagnostic cystoscopy. General anesthesia, spinal anesthesia, epidural anesthesia and senile block methods may be performed in therapeutic systoscopy. Diagnostic cystoscopies may be performed via sedoanalgesia, local anesthetic spray administration, penile block or without any type of anesthesia. Female patients having short urethra are more compatible for local techniques or for the procedures without anesthesia.

Pain is main reason of failed cystoscopy. Sedoanalgesia and LMA are generally used for diagnostic cystoscopies. LMA is mostly placed under general anesthesia with the combination of propofol-fentanyl and volatile anesthetics. There is no need for muscle relaxant administration in LMA placement, as it is necessary for intubation. However if muscle relaxant is not used, side effects like hiccup, straining, cough, undesirable muscle movement, hypoxia and laryngeal spasm may be observed. Placement of LMA may be difficult or sometimes impossible in some patients with limited mouth opening. These patients may experience complications like pain and burning in the mouth, pain in the ear, hoarse voice, swallowing difficulty because of difficult LMA placement in postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients
  • ASA I-II patients
  • Cystoscopy patients
  • patients entubated with lariyngeal mask

排除标准

  • Female patients
  • Asa III-IV patients
  • Surgery duration is more than 2 hours
  • Drug abusers
  • Non compromising patients

研究组 & 干预措施

lma with rocuronium bromide

Experimental

In study group, 2-3 mg/kg propofol, 1mcg/kg fentanyl and 0.15 mg/kg rocuronium bromide will be administered during lma insertion in cystoscopy procedure.

干预措施: Rocuronium Bromide (Drug)

lma with rocuronium bromide

Experimental

In study group, 2-3 mg/kg propofol, 1mcg/kg fentanyl and 0.15 mg/kg rocuronium bromide will be administered during lma insertion in cystoscopy procedure.

干预措施: Fentanyl (Drug)

lma with rocuronium bromide

Experimental

In study group, 2-3 mg/kg propofol, 1mcg/kg fentanyl and 0.15 mg/kg rocuronium bromide will be administered during lma insertion in cystoscopy procedure.

干预措施: Propofol (Drug)

lma with rocuronium bromide

Experimental

In study group, 2-3 mg/kg propofol, 1mcg/kg fentanyl and 0.15 mg/kg rocuronium bromide will be administered during lma insertion in cystoscopy procedure.

干预措施: cystoscopy (Procedure)

lma with saline solution

Active Comparator

In control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure.

干预措施: Saline Solution (Drug)

lma with saline solution

Active Comparator

In control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure.

干预措施: Fentanyl (Drug)

lma with saline solution

Active Comparator

In control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure.

干预措施: Propofol (Drug)

lma with saline solution

Active Comparator

In control group, 2-3 mg/kg propofol, 1 mcg/kg fentanyl and saline(no rocuronium) will be administered during lma insertion in cystoscopy procedure.

干预措施: cystoscopy (Procedure)

结局指标

主要结局

questionnaire

时间窗: up to first 60 minutes

The quality of LMA placement with or without neuromusculer drug.

次要结局

  • questionnaire(up to first 24 hours)

研究者

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

Ayse Ulgey

associate professor

TC Erciyes University

研究点 (1)

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