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临床试验/NCT05588336
NCT05588336已完成4 期

Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection

Cukurova University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年4月25日最近更新:
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
46
试验地点
1
主要终点
pain scores

研究概览

简要总结

Thoracic surgery is one of the surgeries where postoperative pain is intense. In this study, the investigators aimed to compare the efficacy of two different intrathecal morphine doses administered for postoperative analgesia according to patients' ideal body weight.

详细描述

Patients who underwent video-assisted thoracic surgery were divided into two groups: 10 mcg/kg and 7 mcg/kg intrathecal morphine for postoperative analgesia. Intraoperative and postoperative hemodynamic variables, postoperative morphine consumption, postoperative pain scores, side effects and additional analgesic requiretment were recorded.

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
Triple (Participant, Care Provider, 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

  • > 18 years old
  • ASA class I and II
  • Video-assisted thoracoscopic surgery

排除标准

  • < 18 years old
  • ASA class > II
  • Serious hepatic, cardiac, renal, metabolic, endocrine diseases
  • Coagulation disfunction
  • Allergy to any of the study drugs
  • Pneumonectomy
  • Infection in the lumbar region

研究组 & 干预措施

7 mcg/kg intrathecal morphine

Active Comparator

For postoperative analgesia, before surgical incision 7 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position.

干预措施: Morphine (Drug)

10 mcg/kg intrathecal morphine

Active Comparator

For postoperative analgesia, before surgical incision, 10 mcg/ideal body weight morphine HCl (in 2 ml volume) was administered intrathecally at L4-5 interspace in the lateral decubitis position.

干预措施: Morphine (Drug)

结局指标

主要结局

pain scores

时间窗: Change from baseline pain scores at 24 hours

Postoperative pain scores of the patients were recorded via Visual Analog Scale (VAS; 0= no pain, 10= worst pain)

morphine consumption

时间窗: Change from baseline morphine consumption at 24 hours

At the end of surgery, patients were allowed to use the patient controlled analgesia (PCA) device. The PCA delivered bolus doses of morphine (0.02 mg/kg) every 10 minutes without a backround infusion. Morphine consumption (mg) was evaluated and recorded postoperative 24 hours.

次要结局

  • systolic arterial blood pressure(change from baseline systolic blood pressure at 150 minutes)
  • diastolic arterial blood pressure(change from baseline diastolic blood pressure at 150 minutes)
  • mean arterial blood pressure(change from baseline mean arterial blood pressure at 150 minutes)
  • heart rate(change from baseline heart rate at 150 minutes)
  • side effects(postoperative 24 hours)

研究者

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

mediha turktan

associate professor

Cukurova University

研究点 (1)

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