Randomized Clinical Trial to Compare the Efficacy of Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain control
研究概览
简要总结
The goal of this clinical trial is to compare opioid free anesthesia versus opioid anesthesia in patients undergo laparoscopic colorectal surgery. The main question it aims to answer is assess the efficacy of opioid-free anaesthesia respect to postoperative pain control in patients undergoing a laparoscopic colorectal surgery.
Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).
The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.
详细描述
The objective of the study is to know the efficacy of OFA in laparoscopic colorectal surgery. The consumption of opiates will be evaluated according to the VAS scale, defining non-tolerable pain greater than 5. The number of rescues required, the time elapsed until the first rescue and the total consumption of opiates administered will be evaluated.
Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.
Other variables evaluated will be postoperative complications:
- Postoperative hypoxemia.
- Incidence of postoperative nausea and vomiting (PONV).
- Postoperative ileus.
- surgical complications.
- medical complications
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •( - ) Patients older than or equal to 18 years.
- •(-) Patients scheduled for laparoscopic colorectal surgery.
- •(-) Patients with physical status classification (ASA) I-III.
- •(- ) Patients who have signed the informed consent of the clinical trial
排除标准
- •(-) Pregnant or lactating patients.
- •(-)Patients with allergy to any of the drugs or excipients used in the study
- •(-) Emergency laparoscopic colorectal surgery
- •(-) Patients with AV block, intraventricular block, or sinus block
- •(-) Adam-Stokes syndrome.
- •(-) Patient on chronic beta-blocker treatment with HR < 50 bpm
- •(-) Patient with ejection fraction < 40% known
- •(-) Epilepsy.
- •(-) Surgery converted to open surgery
- •(-) Legally disabled patient
- •(-) Patients with physical status classification (ASA) IV.
研究组 & 干预措施
Opioid free anesthesia (OFA)
This arm is administered by the anesthesiologist in charge of the operating room.
It is composed by Dexmedetomidine (Dexdor), Lidocaine, Magnesium Sulfate and ketamine (Ketolar).
干预措施: Opioid free anesthesia (Drug)
Opioid based Anesthesia (OA)
This arm is administered by the anesthesiologist in charge of the operating room.
This arm is composed of Remifentanil hydrochloride and postoperative rescue analgesia will be morphine.
干预措施: Opioid based Anesthesia (Drug)
结局指标
主要结局
Pain control
时间窗: 3 days
milligrams of opioids required postoperatively during the first 3 of admission
次要结局
- VNS score(3 days)
- morphine rescues(7 days)
研究者
Unai Ortega Mera
Principal Investigator
Osakidetza