70. 広範脊柱管狭窄症 Spinal stenosis Clinical trials / Disease details
臨床試験数 : 96 / 薬物数 : 203 - (DrugBank : 60) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 89
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2015-002694-37-FI (EUCTR) | 01/09/2016 | 04/01/2016 | Dexmedetomidine is a drug that is used mainly for sedation in the intensive care unit. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. | Dexmedetomidine infusion in pain management during low back surgeryDexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain.DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control.Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding. | Low back pain, Discus prolapse, Spinal stenosis;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | Trade Name: Dexmedetomidine Product Name: Dexdor INN or Proposed INN: DEXMEDETOMIDINE | Kuopio University hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | Finland | ||||
| 2 | EUCTR2014-003252-31-FI (EUCTR) | 15/05/2015 | 22/04/2015 | Dose-response of dexmedetomidine in patient controlled analgesia in orthopaedic surgery patients | Dose response study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in orthopaedic spine surgery patients - DoserespDex_2.0 | Patients, who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation MedDRA version: 17.1;Level: LLT;Classification code 10041595;Term: Spinal stenosis lumbar;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11] | Trade Name: Dexdor INN or Proposed INN: deksmedetomidiini Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE Trade Name: Oxanest INN or Proposed INN: oksikodoni Other descriptive name: OXYCODONE HYDROCHLORIDE | University of Turku | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Finland |