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临床试验/NCT03426527
NCT03426527已完成不适用

Levobupivacaine Versus Levobupivacaine - Dexmedetomidine for Ultrasound Guided Bilateral Superficial Cervical Plexus Block for Upper Tracheal Resection and Reconstruction Surgery Under General Anesthesia

Mansoura University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年3月1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
入组人数
80
试验地点
1
主要终点
Cumulative postoperative opioid consumption

研究概览

简要总结

Tracheal resection and reconstruction (TRR) is the treatment of choice for most patients with tracheal stenosis or tracheal tumors .The post intubation tracheal stenosis is the common indication for (TRR).The immediate postoperative period can be anxiety provoking for some reasons such as requirement to maintain a flexed neck, oxygen mask, and surgical pain which inadequately treated.

Bilateral superficial cervical plexus block (BSCPB) is a popular regional anesthesia technique for its feasibility and efficacy. The use of regional anesthesia in combination with general anesthesia may lighten the level of general anesthesia required , provide prolonged postoperative analgesia and reduce the requirements for opioid analgesics

Dexmedetomidine is a highly selective α2 agonist with high affinity for α2 adrenergic receptors and less α1 effects, which is responsible for the hypnotic and analgesic effects. Previous trials demonstrated that perineural dexmedetomidine in combination with bupivacaine enhanced sensory and motor block ,without neurotoxicity ,in both experimental and clinical studies.

Levobupivacaine, is "S"-enantiomer of bupivacaine, has strongly emerged as a safer alternative for regional anesthesia than bupivacaine . Levobupivacaine has been found to be equally efficacious as bupivacaine, but with a superior pharmacokinetic profile.

Clinically, levobupivacaine has been observed to be well tolerated in regional anesthesia techniques both after bolus administration and continuous post-operative infusion.

详细描述

The aim of this study is to evaluate the intra- and postoperative efficacy of levobupivacaine versus levobupivacaine - dexmedetomidine for superficial cervical plexus block for upper tracheal resection and reconstruction surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status I or II.

排除标准

  • History of allergy to the drugs used
  • Coagulation disorders
  • Pregnancy
  • Postpartum period.
  • Lactating females
  • Local sepsis

研究组 & 干预措施

Levobupivacaine

Placebo Comparator

Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia

干预措施: Levobupivacaine (Drug)

Levobupivacaine

Placebo Comparator

Patients will receive bilateral superficial cervical plexus block using levobupivacaine General anesthesia

干预措施: General Anaesthesia (Other)

Levobupivacaine-Dexmedetomidine

Active Comparator

Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia

干预措施: Levobupivacaine-Dexmedetomidine (Drug)

Levobupivacaine-Dexmedetomidine

Active Comparator

Patients will receive bilateral superficial cervical plexus block using levobupivacaine-dexmedetomidine General anesthesia

干预措施: General Anaesthesia (Other)

结局指标

主要结局

Cumulative postoperative opioid consumption

时间窗: For 24 hours after surgery

Total postoperative opioid consumption

次要结局

  • Diastolic blood pressure(Before and for 6 hours after start of anaesthesia)
  • Heart rate(Before and for 6 hours after start of anaesthesia)
  • Systolic blood pressure(Before and for 6 hours after start of anaesthesia)
  • Pain scores(For 24 hours after surgery)
  • Peripheral oxygen saturation(Before and for 6 hours after start of anaesthesia)
  • Cortisol serum level(before induction of anaesthesia , one hour after the block then one hour after recovery)
  • End-tidal carbon dioxide tension(Before and for 6 hours after start of anaesthesia)
  • Time for first analgesic request of analgesia following extubation(For 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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