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临床试验/NCT03774693
NCT03774693Unknown不适用

Efficacy of Regional Block of the Nose in Achieving Hypotensive Anaesthesia in Septo-rhinoplasty Surgery

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Hypotensive anesthesia

研究概览

简要总结

Septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. It can be done under general anesthesia, twilight anesthesia or regional anesthesia. Controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome.

The goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists (ASA) physical status I-II
  • •Scheduled for elective septo-rhinoplasty surgery

排除标准

  • •Patients with hypertension or coronary artery disease,
  • •Patients with renal, hepatic or cerebral insufficiency,
  • •Patients with coagulopathy or receiving drugs influencing blood coagulation,
  • •Patients with known sensitivity to any of the study drug

研究组 & 干预措施

GS [General anesthesia]

Active Comparator

Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

干预措施: General anesthesia with fentanyl boluses (Other)

GR [General anesthesia + regional block]

Active Comparator

Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

干预措施: General anesthesia with fentanyl boluses (Other)

GR [General anesthesia + regional block]

Active Comparator

Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

Also patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block. Fentanyl boluses of 0.5 mcg.Kg-1 will be given when needed to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1.

干预措施: Regional block (Procedure)

结局指标

主要结局

Hypotensive anesthesia

时间窗: Intraoperative

Measurement of Mean arterial blood pressure

Requirements of Fentanyl

时间窗: Intraoperative

Assessment of intraoperative fentanyl doses of \[Fentanyl boluses of 0.5 mcg.Kg-1 will be given to maintain mean arterial pressure (MAP) between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1\]

次要结局

  • Average category scale (ACS)(Intraoperative)

研究者

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

Hanan Mahmoud Farag Awad

Assisstant Professor

Ain Shams University

研究点 (1)

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