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临床试验/NCT06390046
NCT06390046已完成不适用

Comparison of Total Intravenous Anesthesia and Inhalational Anesthesia in Opioid-Free Anesthesia for Bariatric Surgery: A Randomized Controlled Trial

Jagiellonian University2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2024年4月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
280
试验地点
2
主要终点
presence of PONV in postoperative period

研究概览

简要总结

Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient.

详细描述

Patients undergoing bariatric surgery were randomly divided into two groups: one under complete intravenous anesthesia (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine) and the other group under combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane). In the postoperative period, all patients will receive Oxycodone NCA or in the form of oral tablets [naloxone (naloxone hydrochloride) + oxycodone (oxycodone hydrochloride)] and coanalgesics in the form of Paracetamol, Dexac, and Metamizol. Both methods of anesthesia are commonly used and used during bariatric and other surgical procedures. It should be emphasized once again that the above-mentioned all drugs are approved for routine use during anesthesia of patients, including obese patients, and our intervention only involves the use of a specific regimen from among those routinely available. The choice of anesthesia method depends on the anesthesiologist. During the study, we want to randomize patients into two groups: one will be anesthetized using a completely intravenous method, the other will be anesthetized using an inhalation anesthetic. In the postoperative period, patients will have their pain level assessed using the NRS scale 1, 2, 6, 12 and 24 hours after the procedure.

This study aimed to compare TIVA (propofol plus non-opioid adjuncts) with a sevoflurane-based anesthesia protocol, both incorporating OFA principles with lidocaine, ketamine, and dexmedetomidine infusions, in patients undergoing laparoscopic bariatric surgery. We hypothesized that both regimens would provide effective analgesia and recovery, with differences in recovery characteristics and postoperative nausea profiles. Moreover, we intended to evaluate whether a sevoflurane-based approach could match the clinical benefits of TIVA while aligning with current ecological and sustainability priorities in anesthesia.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years who underwent laparoscopic bariatric surgery

排除标准

  • Patients with a history of allergic reactions to drugs Patients with a history of drug addiction Patients with chronic pain who require analgesics History of hospitalization for psychiatric disorders Preoperative pulse oximetry (SpO2) < 95 % bradycardia (HR<50bpm), hypotension, atrioventricular block, intraventricular or sinus block Blood clotting disorders Pregnant/lactating women Cognitive impairment Unable to read consent

研究组 & 干预措施

TIVA

Active Comparator

total intravenously anesthetized (infusion of Propofol, Ketamine, Lignocaine and Dexmedetomidine)

干预措施: TIVA versus Inhalation (Drug)

Inhalation agent

Experimental

combined general anesthesia (infusion of Ketamine, Lignocaine and Dexmedetomidine and inhalation of Sevoflurane)

干预措施: TIVA versus Inhalation (Drug)

结局指标

主要结局

presence of PONV in postoperative period

时间窗: 1 day

The incidence of postoperative nausea and vomiting (PONV) within the first 24 hours after surgery

次要结局

  • Postoperative recovery parameters(1 day)
  • Opioid consumption(1 day)

研究者

发起方
Jagiellonian University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Skladzien

PHD MD

Jagiellonian University

研究点 (2)

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