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临床试验/NCT01871922
NCT01871922已完成不适用

Evaluation of the Effects of the Addition of Atropine During Propofol/Remifentanil Induction of Anesthesia on Hemodynamics, Microvascular Blood Flow and Tissue Oxygenenation in Patients Undergoing Ophthalmic Surgery

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Cardiac output

研究概览

简要总结

Remifentanil is a widely used potent intravenous opioid with the advantage of having a short time of action. Compared to other opiates however remifentanil generates more intense hemodynamic side-effects. In ophthalmic surgery the specific anesthesiological challenges necessitate the administration of a combination of relatively high doses of analgesics on the one hand and a short time for postoperative recovery from anesthesia on the other. For these reasons, anesthetic management often consists of a combination of relatively high doses of propofol and remifentanil. A primary concern during this deep propofol/remifentanil anesthesia is preserving hemodynamic stability and adequate tissue oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on hemodynamics as well as on tissue oxygenation. Therefore, the investigators hypothesize that administration of intravenous atropine during induction of propofol/remifentanil may have a positive effect on the hemodynamic profile and peripheral and cerebral tissue oxygenation during and after induction of anesthesia.

研究设计

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

入排标准

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

入选标准

  • Patients requiring general anaesthesia;
  • Patient's age ≥ 18 years and older;
  • Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.

排除标准

  • Patient's refusal;
  • Pregnancy;
  • Patient's age < 18 years;
  • Patients in which atropine is contra-indicated, such as severe aortic valve stenosis, hypertrophic cardiomyopathy or coronary artery disease.

研究组 & 干预措施

General anesthesia + placebo

Placebo Comparator

Propofol/remifentanil anesthesia + saline

干预措施: Placebo (Drug)

General anesthesia + atropine

Active Comparator

Propofol/remifentanil anesthesia + atropine

干预措施: Atropine (Drug)

结局指标

主要结局

Cardiac output

时间窗: During anesthesia

Cerebral tissue oxygen saturation

时间窗: During anesthesia

Peripheral tissue oxygen saturation

时间窗: During anesthesia

次要结局

  • Heart rate(During anesthesia)
  • Mean arterial blood pressure(During anesthesia)
  • Systemic vascular resistance(During anesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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