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临床试验/NCT07075302
NCT07075302已完成不适用

Comparison of Postoperative Morphine Requirements Between an Opioid-Based and an Opioid-Free Anesthesia Technique in Morbidly Obese Patients Undergoing Bariatric Surgery

Hospital HM Nou Delfos1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Total postoperative morphine consumption (mg)

研究概览

简要总结

This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). The main goal is to determine whether avoiding opioids during surgery leads to lower postoperative morphine requirements and fewer side effects. Researchers reviewed medical records of 70 patients who had bariatric surgery between June 2022 and December 2023 at a hospital in Spain. The study evaluates pain levels, sedation, complications, and total morphine use in the first 48 hours after surgery.

详细描述

This is a single-center, retrospective, observational cohort study conducted at Hospital HM Nou Delfos (Barcelona, Spain). The aim is to compare postoperative opioid requirements and outcomes in patients with morbid obesity undergoing laparoscopic bariatric surgery, according to the intraoperative anesthesia technique used.

Two anesthetic strategies were evaluated:

Opioid-Free Anesthesia (OFA): Total intravenous anesthesia (TIVA) without opioids, using agents such as propofol, ketamine, dexmedetomidine, lidocaine and magnesium.

Opioid-Based Anesthesia (OBA): TIVA including opioids, following institutional standards.

Medical records of 70 patients (35 in each group) who underwent surgery between June 2022 and December 2023 were analyzed. Key data extracted included demographics, surgical duration, anesthetic drugs used, intraoperative complications, pain scores (VAS at 1, 2, 4, 24, and 48 hours), sedation levels (RAMSAY scale), adverse effects (e.g., nausea, vomiting, ileus, hypotension), and morphine consumption.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Total postoperative morphine consumption (mg)

时间窗: From 0 to 48 hours after surgery

Cumulative amount of morphine (in milligrams) administered within the first 48 hours after surgery, as recorded in the post-anesthesia care unit and inpatient medical records.

次要结局

  • Sedation level (RAMSAY scale)(From 0 to 48 hours after surgery)
  • Pain intensity (VAS)(At 1, 2, 4, 24, and 48 hours postoperatively)
  • Incidence of adverse events(Up to 48 hours after surgery)
  • Length of hospital stay(From surgery until discharge (up to 7 days))
  • Time to awakening(Intraoperative period until recovery (measured at end of surgery))

研究者

发起方
Hospital HM Nou Delfos
申办方类型
Other
责任方
Principal Investigator
主要研究者

HIPÓLITO LABANDEYRA GONZALEZ

Anesthesiologist

Hospital HM Nou Delfos

研究点 (1)

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