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临床试验/NCT05591105
NCT05591105已完成不适用

Post-operative Morphine Consumption in Obese Patients Undergoing Laparoscopic Bariatric Surgery Following Ketamina and Lidocaine Perfusion

Tiva Group1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Postoperative morphine consumption

研究概览

简要总结

The goal of this observational study is to evaluate the quality of postoperative analgesia in a group of obese patients schedule to bariatric surgery under TIVA Opiod-free after to receive lidocaine and ketamine perfusion. The main question it aims to answer are: How lidocaine and ketamine perfusion during recovery period does impact over morphine consumption on the following 48 hours after surgery? All participants will receive total intravenous anesthesia and, at the end of the surgery, they will be divided in two groups, group A: placebo and, group B: with postoperative lidocaine and ketamine perfusion. Our hypothesis is ketamine and lidocaine are a good alternative to decrease the use of morphine in obese patients.

详细描述

The obese patients have more risk for certain side effects and complications with elevated risk of perioperative mortality and morbidity. An effective postoperative pain management is important to prevent pulmonary complications and, it is not recommended continuous infusions of opioids in this kind of patients, because the opioid-induced upper airway obstruction and respiratory depression are more likely to be seen in obese patients with obstructive sleep apnea. We can reduce perioperative opioid using dexmedetomidine, ketamine and lidocaine, however, it is a little know the use and benefits of lidocaine and ketamine inmediately after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients between 18 y 65 years old.
  • IMC > 30 kg/m2
  • ASA II/III

排除标准

  • Patients taking high doses of opioids before operation for chronic pain
  • Patients with allergies to any study medication.
  • Pregnancy or breastfeeding.
  • Kidney or heptic failure.
  • Surgical complication

研究组 & 干预措施

Group A:

At the end of surgery, on the recovery room, this group will receive lidocaine (1 mg/kg/h) and Ketamine (0,15 mg/kg/h) for 90 minutes

干预措施: Control Group (Drug)

Group B:

At the end of surgery, on the recovery room, this group will receive placebo (normal salin solution) for 90 minutes

干预措施: Placebo (Drug)

结局指标

主要结局

Postoperative morphine consumption

时间窗: 48 hours

The visual analog scale (VAS) will be used to measure pain on recovery room and hospitalization area.

次要结局

未报告次要终点

研究者

发起方
Tiva Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolina Frederico

Principal Investigator

Tiva Group

研究点 (1)

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