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临床试验/NCT00389883
NCT00389883已完成3 期

Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2006年11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
入组人数
69
试验地点
2
主要终点
Time from discontinuing anesthesia and extubation.

研究概览

简要总结

This is a double center, multidisciplinary, prospective, randomized, double-blind, with a superiority hypothesis, trial including 100 patients scheduled for resection of a supratentorial brain tumour under general anesthesia.

详细描述

On the morning of surgery, patients will be randomly allocated to one of the two following groups : target concentration-delivered propofol-remifentanil versus sufentanil-sevoflurane. The primary judgement criterion will be the rapidity of awakening, defined as the time between the cessation of administration of the last anesthetic until extubation. Several secondary judgement criteria related to quality of postoperative recovery and complications will be collected. The hypothesis tested is a 30% reduction of the time necessary to extubate patients after cessation of anesthetic delivery in the propofol-remifentanil group. Based on previous works, using an risk of 20 % and an of 5 %, 100 patients must be included in this study (50 or each group). Statistical analysis will be performed by WILCOXON MANN, WHITNEY and X2 tests based on the type of variables.

The results of this study should provide a first choice anaesthetic regimen to optimize postoperative recovery of neurosurgical patients undergoing resection of supratentorial brain tumours. They will contribute to the improvement in the management of patients suffering from cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient scheduled for supratentorial brain tumors remove.
  • Age : 18 to
  • ASA 1 or 2.

排除标准

  • Disagree of patient to participate
  • Intubation required in the postoperative care unit
  • Contraindication of one of the anesthetics used in the study
  • Pregnancy
  • Craniotomy in the frontal area (no depth of anesthesia monitoring)
  • Patient's inability to quantified its pain.

研究组 & 干预措施

1

Active Comparator

propofol et remifentanil

干预措施: Comparison of two anesthetics protocol (Drug)

2

Experimental

sevoflurane et sufentanil

干预措施: Comparison of two anesthetics protocol (Drug)

结局指标

主要结局

Time from discontinuing anesthesia and extubation.

时间窗: during 24 hours

次要结局

  • Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.(during 24 hours)
  • Speed of emergence from anesthesia : time from discontinuing anesthesia to spontaneous breathing, opening the eyes, response to simple order and discharge from postoperative care unit.(during 24 hours)
  • Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.(during 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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