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临床试验/NCT06052111
NCT06052111已完成不适用

Dexmedetomidine Versus Fentanyl on Time to Extubation in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy: A Randamized Controlled Trial

Helwan University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年5月15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
64
试验地点
1
主要终点
The time for extubation

研究概览

简要总结

This study aims to compare the efficacy of dexmedetomidine versus fentanyl during general anesthesia for patients with morbid obesity undergoing laparoscopic sleeve gastrectomy.

详细描述

The use of opioids in surgeries for patients with morbid obesity is controversial since they are known for having ventilatory depressing effects. Therefore, alternative analgesics are needed to improve anesthetic management for patients with obesity.

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, Outcomes Assessor)

入排标准

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

入选标准

  • Age from 20 to 50 years old.
  • Both sexes.
  • American Standards Association (ASA) physical status II - III.
  • Body Mass Index (BMI) ≥ 35 kg/m2.

排除标准

  • Allergy to α2 -adrenergic agonist.
  • History of cardiac disease (uncontrolled hypertensive patient with blood pressure above 140/90, implanted pacemaker, poor cardiac function (ejection fraction< 50%), history of myocardial infarction, cerebral stroke, transient ischemic attack, or coronary artery disease with or without stents.
  • Neuromuscular disease, liver disease (coagulopathy INR>1.5 or platelet count <100.000/μl), renal impairment (serum creatinine >1.2mg/dl, serum K >5.5mmol/l).
  • Opioid medication within 24 hours before the operation.
  • Respiratory diseases as COPD, uncontrolled asthmatic patients.

研究组 & 干预措施

Group F (fentanyl group)

Experimental

Fentanyl (1 μg/kg) was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose followed by continuous infusion at a rate of (1μg/kg/hr) after intubation. It was stopped 10 minutes before the end of surgery.

干预措施: Group F (fentanyl group) (Drug)

Group D (dexmedetomidine group)

Experimental

The patients were received a loading dose of dexmedetomidine (1 μg/kg) intravenously over 15 minutes before induction of anesthesia, followed by continuous infusion at a rate of (0.6 μg/ kg/ hr) after intubation and was stopped 10 minutes before the end of surgery.

干预措施: Group D (dexmedetomidine group) (Drug)

结局指标

主要结局

The time for extubation

时间窗: 30 minutes till end of surgery.

Time from end of anesthesia till safe extubation of the patients

次要结局

  • Mean arterial blood pressure (MAP)(Intraoperatively.)
  • Heart rate (HR)(Intraoperatively)
  • Incidence of hypotension(Intraoperatively)

研究者

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

Doha Mohammed Bakr

Assistant lecturer in Anesthesiology, Intensive care and Pain management, Faculty of Medicine, Helwan University, Qism Helwan Egypt.

Helwan University

研究点 (1)

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