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临床试验/NCT04086940
NCT04086940Unknown4 期

Lecturer of Anesthesia

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
intraoperative analgesic requirements

研究概览

简要总结

Using esmolol during anesthetic maintenance of laparoscopic bariatric surgery significantly decreases anesthetic, analgesic requirements, postoperative pain, PNV and postoperative hypoxia.

详细描述

Postoperative pain, nausea, vomiting (PNV) and hypoxia are common in relation to laparoscopic bariatric surgery. Sympatholytic drugs might decrease the need for intravenous or Inhalation anesthetics and opioids. In this study we wanted to analyze effects of esmolol on intraoperative anesthetic-analgesic requirements, postoperative analgesic requirements, postoperative pain, PNV and hypoxia.

Methods: Sixty patients have been included. Propofol, fentanyl and rocuronium were used for induction. Study groups were as follows; group E Esmolol infusion was added to maintenance anesthetics (Sevoflurane and fentanyl), group N only Sevoflurane and fentanyl was used during maintenance. They have been monitored during the intraoperative period and postoperatively for 24 h for analgesic requirements and PNV. Visual analog scale (VAS) scores for pain was also been assessed.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) I - II patients
  • age between 18-59 years
  • both genders
  • body mass index (BMI) > 45 kg/m2

排除标准

  • Patients with -hepatic
  • respiratory diseases
  • patients with a history of drug abuse or who were dependent on opioid drugs.

研究组 & 干预措施

esmolol(breviblock) group

Active Comparator

Patients in group E received a loading dose of esmolol(breviblock) 1 mg/kg in 50 ml isotonic saline over 30 minutes before induction of anesthesia, then followed by an infusion of esmolol 10 µg/kg/min until the end of the surgery.

干预措施: Esmolol (Drug)

non esmolol group

Active Comparator

Patients in group N received 50 ml of isotonic saline over 30 min, followed by an infusion of isotonic saline at same rate of group E till the end of the surgery.

干预措施: Esmolol (Drug)

结局指标

主要结局

intraoperative analgesic requirements

时间窗: 6 months

amount of narcotics and anesthetics needed

postoperative analgesic requirements

时间窗: 6 months

amount of narcotics needed

次要结局

未报告次要终点

研究者

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

RAMY AHMED

lecturer of anesthesia at faculty of medicine ain shams university

Ain Shams University

研究点 (1)

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