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临床试验/NCT04508894
NCT04508894已完成不适用

Ketamine Versus Dexmedetomidine as an Adjuvant in Ultrasound-guided Supraclavicular Brachial Plexus Block

Minia University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年4月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Evaluate duration of sensory block

研究概览

简要总结

Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.

Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind

详细描述

This randomized, prospective, double-blind study was carried out on 75 ASA Physical Status I-II adults aged 18-75 years old scheduled to undergo elective and emergency forearm and hand surgeries under ultrasound-guided supraclavicular brachial plexus block. After obtaining the local ethics committee of El-Minia university hospital approval and written informed consent was taken of the patient, this study was conducted from April 2019 to February 2020 in El-Minia university hospital. The investigators excluded any patient with bleeding disorders, damage or disease of the brachial plexus, uncontrolled diabetes mellitus, and patients with neuromuscular diseases, Patients with a local skin infection at the site of injection or patients with known hypersensitivity to studied drugs.

Preoperative assessment and preparation: A careful assessment of medical history, general examination including chest, heart, abdomen, site of injection and other systems were carried out. Routine investigations were done as complete blood picture, ECG (electrocardiogram) renal and liver functions. An explanation of the visual analog scale was done to each patient.

Preparation of the studied medications: The patients were randomly classified into three groups using computer-generated table numbers each contains (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D) 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine (precedex® Hospira,Inc., Lake Forest USA).

Control group (group C) 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. All medications were prepared in similar sterile coated bottles by the supervisor who didn't include in the anesthetic or operative team, 75 bottles numbered from 1 to 75 were prepared. After completion of the study, the key was opened by the supervisor Block technique: On patient's arrival to the operating room, a 20 G intravenous cannula was inserted in a peripheral vein of unaffected limb and standard monitoring commenced as noninvasive blood pressure (NIBP), (ECG), and Oxygen saturation (Spo2) (UltraviewSL2700, Spacelaps, USA), all equipment and drugs for general anesthesia and resuscitation were prepared, the ultrasound device (Sonosite, Nanomax, USA ) lubricating gel, 21guge 50 mm length, short bevel, insulated stimulating needle (Laboratoires pharmaceutiques, Vygon, France). Patient lie supine with the head turned to the other side and ipsilateral arm adducted gently with a flexed elbow. Under the complete aseptic condition, the identified area and the ultrasound probe was prepared with anti-septic (Povidone-Iodine 10%) solution and the skin infiltrated with 1-2 ml of lidocaine 2% solution subcutaneously, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the supraclavicular brachial plexus was seen, it either appeared as a grape-like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region or as 3 hypoechoic circles with hyperechoic outer rings, the predetermined volume of 40 mL of the study drug solution was administered around the brachial plexus after negative aspiration to avoid accidental intravascular injection, expansion of the brachial plexus sheath was considered as an indication of correct needle placement, multiple injections were used to deposit the total amount of the study drugs, skin massage for about 3 minutes was done to facilitate drug distribution.

Parameters assessed:

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Physical Status I or II
  • patients undergoing elective and emergency forearm and hand surgeries

排除标准

  • Patient with bleeding disorders
  • Damage or disease of the brachial plexus
  • Uncontrolled diabetes mellitus
  • Patients with neuromuscular diseases
  • Patients with a local skin infection at the site of injection
  • Patients with known hypersensitivity to studied drugs

研究组 & 干预措施

Control group

Placebo Comparator

Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline

干预措施: Supraclavicular Brachial Plexus Block with bupivacaine (Drug)

Ketamine group

Active Comparator

Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine

干预措施: Supraclavicular Brachial Plexus Block with Ketamine (Drug)

Dexmedetomidine group

Active Comparator

Supraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine

干预措施: Supraclavicular Brachial Plexus Block with Dexmedetomidine (Drug)

结局指标

主要结局

Evaluate duration of sensory block

时间窗: 24 hours after block

Sensory block duration: the time interval between the complete sensory block and complete resolution by hours

次要结局

  • time to first analgesic request(24 hours)
  • sedation score(24 hours after surgery)
  • Evaluate onset of sensory and motor block(30 minute after block)
  • total analgesic requirements(24 hours after surgery)
  • Assess postoperative pain score(For 24 hours after surgery)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

haidy salah mansour

Professor

Minia University

研究点 (1)

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