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临床试验/NCT01718756
NCT01718756暂停1 期

Efficacy of Continuous Intravenous Infusion vs. Scheduled Dosing of Lornoxicam on Patient Controlled Morphine Consumption After Orthopaedic Surgery: A Comparative Placebo Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
暂停
入组人数
96
试验地点
1
主要终点
postoperative patient controlled morphine consumption

研究概览

简要总结

Perioperative continuous infusion of lornoxicam would be an effective and safe regimen to reduce the patient controlled morphine consumption after orthopaedic surgery.

After ethical approval, 96 patients scheduled for elective orthopaedic fracture surgery under general anaesthesia were randomly allocated to receive placebo, 12-hourly iv lornoxicam 16 mg or lornoxicam 16 mg followed with continuous infusion of 1.3 mg/hr., for 48 hours after surgery (n=32 per group). Anaesthesia was induced with propofol, sufentanil and rocuronium, and was maintained with 0.5-1 minimum alveolar concentration sevoflurane, sufentanil and rocuronium. Postoperative patient controlled morphine analgesia was used. Changes in heart rate, mean blood pressure and sevoflurane minimum alveolar concentration, visual analogue pain scores, and cumulative patient controlled morphine consumptions and blood loss for 48 hours, platelet functions, bone non-union and the presence of adverse effects were recorded.

详细描述

An independent investigator who was not involved in the study instructed the patients preoperatively about the use of visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain) and about the use of PCA for their postoperative pain management.

Anaesthetic management was standardized. Oral lorazepam 2 mg was given the night before surgery. Subjects were allocated randomly into three groups (n = 32 for each) by drawing sequentially numbered sealed opaque envelopes containing a software-generated randomization code (Random Allocation Software, version 1.0.0, Isfahan University of Medical Sciences, Isfahan, Iran)into the placebo, scheduled, and continuous infusion groups. The syringes containing placebo and lornoxicam solutions were masked by identical opaque identical cover sheets. The test solution was prepared by one anaesthesiologist before induction of anaesthesia. Another anaesthesiologist, who was blinded to the study solution, gave the anaesthetic and was instructed to avoid using local anaesthetics, and a third anaesthesiologist collected perioperative data. All staff in the operating room were unaware of patient allocation group.

Patient monitoring included electrocardiography, non-invasive blood pressure, pulse oximetry, end-tidal sevoflurane and carbon dioxide (ETCO2) concentrations, response entropy (RE) and state entropy (SE.

After preoxygenation for 3 min, anesthesia was induced with fentanyl 1 - 3 µg/kg, propofol 1.5-2.5 mg/kg (to achieve an SE <50 and a difference<10 between RE and SE; RE-SE) and rocuronium 0.6 mg/kg. Tracheal intubation or slipping of laryngeal mask appropriate for body weight were used according to the discretion of the attending anaesthetist. Anaesthesia was maintained with a 0.6-1 minimum alveolar concentration of sevoflurane (MAC-Sevo) with air in 40% oxygen and fentanyl 1 µg/kg boluses to maintain SE <50 and RE-SE <10 and heart rate and mean arterial blood pressure within 20% of their baseline values. Rocuronium 0.1 mg/kg was given to maintain suppression of the second twitch using a train-of-four stimulation. The patients' lungs were ventilated to maintain an ETCO2 of 30-35 mmHg. Sevoflurane were discontinued at the start of skin closure, residual neuromuscular block was antagonized and the trachea extubated.

Postoperative analgesia was achieved according to the hospital protocol with patient controlled morphine analgesia (1 mg/ml), 1 mg, with a lockout interval of 8 minutes and a maximum 24-hourly limit of 180 mg. respiratory depression defined as the decrease in respiratory rate below 8/min was treated with i.v naloxone 0.2 mg. Nausea and vomiting were treated with i.v granisetron 1 mg and pruritus was treated with i.m promethazine 25 mg.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical class I to III
  • Age from 18 to 55 years
  • Closed non comminuted long bone fractures
  • Elective orthopaedic fracture surgery
  • General anaesthesia

排除标准

  • Hypersensitivity to lornoxicam
  • Gastrointestinal ulceration or bleeding
  • Cardiac diseases
  • Pulmonary diseases
  • Hepatic diseases
  • Renal diseases
  • Clotting diseases
  • Bleeding diseases
  • Bronchial asthma
  • Diabetes mellitus
  • Peripheral arterial occlusive disease
  • Morbid obesity
  • Pregnancy
  • Alcohol or drug abuse
  • Receiving other NSAIDs a day before surgery

研究组 & 干预措施

Placebo

Placebo Comparator

The placebo group received 12 hourly boluses of 0.9% saline, followed by a constant infusion for 48 hrs after surgery.

干预措施: Placebo (Drug)

Scheduled

Active Comparator

They received a 12 hourly boluses of lornoxicam followed by a constant infusion of 0.9% saline, for 48 hrs after surgery

干预措施: Scheduled (Drug)

Continuous infusion

Active Comparator

They received boluses of lornoxicam 0.8 mg/mL before induction of anaesthesia followed by a 12 hourly boluses of 0.9% saline and a constant infusion at 10 mL/h of lornoxicam 0.13 mg/mL, for 48 hrs. after surgery.

干预措施: Continuous infusion (Drug)

结局指标

主要结局

postoperative patient controlled morphine consumption

时间窗: 24 hours and 48 hours after surgery

The cumulative morphine consumption during the first 24 and 48 postoperative hours were recorded.

次要结局

  • Quality of analgesia(every two hours for 24 hours after surgery)
  • Nausea and vomiting(every two hours for 24 hours after surgery)
  • platelet functions(daily after surgery for three days)
  • Perioperative blood loss(Cumulative intraoperative and 24 hours after surgery)
  • Bone non-union(for 3 months after surgery)
  • postoperative sedation(every two hours for 24 hours after surgery)

研究者

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

Mohamed R El Tahan

Associate Professor of Anesthesiology & SICU

Mansoura University

研究点 (1)

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