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临床试验/NCT02619032
NCT02619032已完成不适用

Remifentanil vs Fentanyl During Day Case Dental Surgery in Persons With Special Needs: a Comparative Study of Their Effect on Stress Response and Postoperative Pain

Attikon Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2005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
发起方
入组人数
46
试验地点
1
主要终点
Change from baseline plasma cortisol values at 1 hour

研究概览

简要总结

This study was a prospective comparative study. The purpose of this study was to investigate the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary aims were to investigate comparatively their effect on patients intraoperative hemodynamic response and postoperative analgesia.

详细描述

The study included 46 adult patients with cognitive impairment who underwent day-case dental surgery under general anesthesia with propofol aiming to keep a BIS-values range between 40-45. Nasal tracheal intubation was performed in all patients while neuromuscular blockade was achieved by rocuronium 0.6 mg/kg iv and repetitive doses of rocuronium of 10 mg iv, if needed.

Patients were randomly allocated receive for intraoperative analgesia either fentanyl 50 μg iv bolus (group F, n=23) or continuous infusion of remifentanil 0.5-1 μg/kg/min (group R, n=23). Randomization was performed using using a computer-generated randomization schedule.

Intraoperatively, patients in both groups received IV granisetron 3 mg, methylprednisolone 125 mg and clindamycin 600 mg, while atropine 0.02 mg/kg and neostigmine (0.05 mg/kg) was administered to to reverse neuromuscular blockade. Intraoperative monitoring included non-invasive measurement of arterial blood pressure, electrocardiogram, pulse oxymetry, capnography and Bispectral Sedation Index (BIS®).

Postoperatively, patients remained under surveillance in the post-anesthesia care unit [PACU] for 3 h. Postoperative pain was assessed for the first 12 postoperative hours, at 30 min time-intervals for the first 3 hours, and every 3 hours thereafter by an independent observer, blinded to the study group, using the Wong-Baker faces pain rating scale (0-6). If pain scores were ≥3 a rescue dose of paracetamol 12.5 mg/kg iv was administered.

Inflammation markers and stress hormones [cortisol, Tumor necrosis factor (TNF-a), substance-P, melatonin and β-endorphin] were measured in each patient before induction of anesthesia, after tracheal intubation and at the end of operation.

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients with cognitive impairment
  • of category II according to the American Society of Anesthesiology (ASA) classification
  • scheduled for elective dental surgery with short duration

排除标准

  • Patients of more than category II of American Society of Anesthesiology (ASA) classification
  • Prolonged duration of surgery (>1 hour)

研究组 & 干预措施

Remifentanil

Active Comparator

Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.

干预措施: Remifentanil (Drug)

Remifentanil

Active Comparator

Drug: Remifentanil (Ultiva). Intraoperative intravenous infusion of remifentanil 0.5-1 μg/kg/min for up to 1 h.

干预措施: Fentanyl (Drug)

Fentanyl

Active Comparator

Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.

干预措施: Remifentanil (Drug)

Fentanyl

Active Comparator

Drug: Fentanyl (FNT). Intraoperative administration of fentanyl given as one single bolus dose of 50 μg at the time of induction of anesthesia.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Change from baseline plasma cortisol values at 1 hour

时间窗: At 1 hour after the induction of anesthesia and surgery

Plasma cortisol values were measured with an ELISA kit as mg/dl

Change from baseline plasma tumor necrosis factor-α (TNF-α) values at 1 hour

时间窗: At 1 hour after the induction of anesthesia and surgery

Tumor necrosis factor-α (TNF-α) measurement was performed with Elisa immunoenzyme assay as pg/ml

Change from baseline plasma substance-P values at 1 hour

时间窗: At 1 hour after the induction of anesthesia and surgery

Substance-P measurement was performed with Elisa immunoenzyme assay as ng/ml

Change from baseline plasma melatonin values at 1 hour

时间窗: At 1 hour after the induction of anesthesia and surgery

Melatonin measurement was performed with Elisa immunoenzyme assay as pg/ml

Change from baseline plasma β-endorphin values at 1 hour

时间窗: At 1 hour after the induction of anesthesia and surgery

β-endorphin was measured with Elisa immunoenzyme assay as ng/ml

次要结局

  • Differences in intraoperative systolic arterial blood pressure values (mm Hg) between the two study groups(1 hour)
  • Differences in intraoperative heart rate values (bmp) between the two study groups(1 hour)
  • Differences in postoperative pain scores scores between the two study groups(Up to 12 postoperative hours)

研究者

发起方
Attikon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paraskevi Matsota

Assoc. Prof. of Anaesthesiology

Attikon Hospital

研究点 (1)

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