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临床试验/NCT06216210
NCT06216210已完成不适用

Assessing the Impact of Opioid-Free Anesthesia Using the Modified Mulimix Technique on Plasma Interleukin-2 and Interleukin-6 Levels in Bariatric Surgery Patients

Zulekha Hospitals1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月22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
60
试验地点
1
主要终点
immunological response

研究概览

简要总结

The effective management of post-operative pain in the setting of bariatric surgery presents significant hurdles for both anesthesiologists and surgeons. The objective of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and the analgesic requirements within the first twenty-four hours after surgery.

详细描述

Objectives: The effective management of post-operative pain in the setting of bariatric surgery presents significant hurdles for both anesthesiologists and surgeons. The objective of this study was to assess the effects of opioid-free anesthesia (OFA) using the modified mulimix technique on the levels of plasma interleukin-2 (IL-2) and interleukin-6 (IL-6) as the primary outcome. Additionally, the study aimed to evaluate the duration of analgesia and the analgesic requirements within the first twenty-four hours after surgery.

Methods: 60 patients were systematically selected and randomly assigned to Group A (OFA) and Group B (Opioid-Containing Anesthesia, OCA), with the modified Mulimix technique employed. Serum samples were collected from all patients, both at the onset of the skin incision and after the surgical procedure. These samples were then used to assess interleukin-2 (IL-2) and interleukin-6 (IL-6) levels. Additionally, the post-operative analgesic consumption was documented.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • both genders
  • aged between 20 and 50 years
  • patients fall under the American Society of Anesthesia (ASA) categories II-III
  • body mass index (BMI) ranging from 35-50.

排除标准

  • patients who declined participation in the trial
  • pregnant women
  • patients who encountered challenges in communication that could potentially impede a dependable postoperative evaluation

研究组 & 干预措施

Group (A)

Opioid-free anesthesia group

干预措施: opioid-FREE anesthesia. (Drug)

Group (B)

Opioid-containing anesthesia group.

干预措施: opioid-CONTAINING anesthesia. (Drug)

结局指标

主要结局

immunological response

时间窗: 20 MONTHS

to detect the immunological response in the form of IL-2 and IL-6.

次要结局

  • The analgesic duration and requirements in the first twenty-four hours postoperatively(20 MONTHS)
  • The Non-Invasive blood pressure at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.(20 MONTHS)
  • comparing the Visual Analog Score(20 MONTHS)
  • Heart rate at baseline, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours.(20 MONTHS)

研究者

发起方
Zulekha Hospitals
申办方类型
Other
责任方
Sponsor

研究点 (1)

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