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临床试验/NCT05880693
NCT05880693已完成1 期

Dexmedetomidine Versus Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries

mohamed1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
The primary outcome was to determine the bleeding score

研究概览

简要总结

General anesthesia organizes the best option for controlled blood pressure during rhinoplasty surgery. The primary agent applied in controlling hypotension should have particular unique characteristics. The dexmedetomidine central and peripheral sympatholytic performance is usually indicated by low blood pressure and low heart rate. magnesium sulfate is among the best agents used.

详细描述

This is a prospective comparative randomized study. 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality. The amount of blood loss during the entire process was measured. The score of pain was evaluated using the NRS rating scale. Sedation score through Ramsey sedation score. The time required for the first requirement of analgesia was also recorded as well as intraoperative and postoperative problems.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years old
  • ASA (American Society of Anesthesiologists) grading I and II
  • patients undergo rhinoplasty surgery under general anesthesia

排除标准

  • The pregnant ladies
  • patients suffering from hypertension ischemic heart diseases renal insufficiency, neuromuscular diseases, hepatic impairment
  • cerebrovascular inadequacy and diabetic neuropathy, coagulopathies,
  • patients taking antiplatelets
  • Refused study,
  • patients of age < 18 or > 60 were unauthorized from the study.

研究组 & 干预措施

group 1

Experimental

The first group (group 1): (n= 28): Received a loading dose of dexmedetomidine 1 μg/kg in a normal saline 0.9% solution of 100 ml 10 minutes before anesthesia induction and then a 0.4 ug/kg/h via syringe infusion pump during the time of surgery.

.

干预措施: Dexmedetomidine (Drug)

group 2

Experimental

The second group (group 2): (n= 28): Received magnesium sulfate 30 mg/kg as a loading dose in a saline 0.9% solution of 100 ml infusion through the syringe pump10 minutes before anesthesia induction and then a 10 mg/kg/h via syringe infusion pump during the time of surgery

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

The primary outcome was to determine the bleeding score

时间窗: 24 hours postoperative period

The primary outcome was to determine the bleeding score, the secondary outcomes included the mean arterial pressure as well as heart rate aiming to arrive at a surgical field free from the blood through controlled Hypotension, determination of surgeon satisfaction, and operation time, they also aided in anesthesia recovery through the use of the Aldrete score, Ramsey sedation score, and the first analgesia postoperative requirement.

次要结局

未报告次要终点

研究者

发起方
mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mohamed

assissant professor of anesthesia

Azhar University

研究点 (1)

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