NCT01323075已完成不适用
Pharmacodynamic Comparison of Truncal Blocks in Patients With or Without Metabolic Disease (Kidney Failure, Diabetes)
Centre Hospitalier Universitaire de Nīmes3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- The duration of sensory block in minutes.
研究概览
简要总结
The primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 1 month of follow up
- •The patient is scheduled for hand or wrist surgery
- •Inclusion Criteria for the "Renal Insufficiency" group
- •Patient has renal insufficiency as defined by a creatine clearance of < 30ml/min without dialysis
- •Inclusion Criteria for the "Diabetes" group
- •Patient has chronic hyperglycemia, either a fasting glycemia > 1.26 g/l (7mmol/l) for longer than 5 years and receiving an oral, well-adjusted (last HBA1c < 6.5%)), non-insulin, antidiabetic treatment
- •Inclusion Criteria for the "Non-exposed" group
- •Patient without metabolic or neurologic disease, with creating clearance > 90ml/min
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant
- •The patient is breastfeeding
- •Patient weighs less than 50 kg
- •Score ASA > 4
- •contra indication for locoregional anesthesia
- •Severe metabolic and / or decompensated renal disease, cardiac or pulmonary decompensation
- •Associated peripheral neuropathy associated with diabetes or kidney disease
- •Associated central neuropathy associated (eg MS ... narrow cervical canal)
- •Patients with both renal failure and diabetes
结局指标
主要结局
The duration of sensory block in minutes.
时间窗: Day 0 (per-op)
The duration of the sensory block in minutes. The beginning of this term is defined by the end of the axillary block (last injection), and the end of this period is defined by the reappearance of sensitivity to touch in the area anesthetized.
次要结局
- Time necessary for installing sensory and motor block (min)(Day 0 (per-op))
- Presence of paresthesia: yes / no(Day 0 (per-op))
- Occurrence of neurological complications, yes/no(1 month)
- Failure of the block: yes / no(Day 0 (per-op))
- Time necessary for completion of axillary blocks (1 / 3 upper humerus)(min)(Day 0 (per-op))
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Dexmedetomidine in Different Dose Levels as Adjuvant to Bupivacaine-induced Ultrasound-guided Femoral Nerve Block.DexmedetomidineFemoral Nerve BlockArthroscopic Knee SurgeryNCT02089932Cairo University60
已完成
3 期
Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)Anesthesia, GeneralNCT00474253Merck Sharp & Dohme LLC115
尚未招募
不适用
A clinical study to evaluate effectiveness of drug tramadol for pain free period after gynecological surgeriesCTRI/2020/08/027221Shree krishna hospital
已完成
不适用
Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic MonitoringNeuromuscular BlockadeNCT05120999Mayo Clinic100
已完成
不适用
Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the AdjuvantsPostoperative PainFractures of the Upper LimbFracture of the Lower Limb (Except Hip), Initial EncounterIntraoperative HypotensionIntraoperative HypertensionPain SyndromeAnesthesiaAnesthesia, LocalLocal Anesthetic Systemic ToxicityPeripheral NeuropathyNCT04498923Lviv National Medical University68