Comparison of Schnider versus Eleveld models for propofol target-controlled infusion anaesthesia in adult bariatric surgery: A randomised controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of mean effective concentration of propofol at return of responsiveness
研究概览
简要总结
Bariatric surgery has emerged as a crucial intervention in the management of morbid obesity
offering significant long-term benefits in terms of weight reduction and improvement of
obesity related comorbidities. However, the anaesthetic management of patients undergoing
bariatric procedures presents unique challenges due to altered pharmacokinetics, increased risk
of airway complications and heightened sensitivity to anaesthetic agents. Inhalational
anaesthesia and total intravenous anaesthesia (TIVA) are both widely used techniques for
inducing and maintaining general anaesthesia. Inhalational agents such as sevoflurane and
desflurane offer ease of administration and rapid titration but may be associated with
postoperative nausea and vomiting (PONV) and environmental pollution. On the other hand,
TIVA—most commonly using propofol with or without adjuncts like remifentanil—provides
a smoother recovery profile, reduced PONV, and better haemodynamic stability in these
patients.
TIVA, especially when delivered via target-controlled infusion (TCI), allows for precise
control of drug concentration at the effect site. This is particularly beneficial in obese patients,
where altered pharmacokinetics can impact drug distribution and metabolism. Propofol a
widely used intravenous anaesthetic, is commonly administered using target -controlled
infusion systems to maintain stable anaesthesia. These systems rely on pharmacokinetics
models to predict drug concentration and guide infusion rates. Amongst the various models
developed the Schnider and Eleveld effect site models are two prominent TCI frameworks
employed in clinical practice. The Schnider model, established earlier, is tailored primarily for
average weight adults, while the more recent Eleveld model is population based and designed
to accommodate a broader range of patient characteristics including age weight and lean body
mass -making it potentially more suitable for obese patients4 which may not be available in all
TCI pumps. Weight correction formula for the same model is CBW=IBW+[0.4×(TBW
IBW). Although the Schnider model uses fixed ke0 while Eleveld uses variable ke0 based on
covariates like age and weight, weight correction formula has been derived for use with the
Schnider model and is widely used in the absence of Eleveld model.
LACUNAE IN EXISTING KNOWLEDGE
The Schnider model is designed to be a universal model across a broad population, however
real-world clinical validation specifically in morbidly obese patients undergoing bariatric
surgery is still limited. Similarly, despite the theoretical advantages of the Eleveld model in the
bariatric populations, there is a lack of robust clinical evidence directly comparing its
performance with the Schnider model in this specific group. This study aims to evaluate and
compare the efficacy, safety and recovery profiles of propofol TCI guided by the Eleveld versus
the Schnider model in adult patients undergoing bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients in the age group of 18-65 yrs.
- •ASA II and III.
排除标准
- •Any known allergy to psychotropic drugs used in the study.
- •Addiction to drugs and alcohol.
- •Chronic opioid therapy.
结局指标
主要结局
Comparison of mean effective concentration of propofol at return of responsiveness
时间窗: After induction at 0 min | Can be variable according to patients
responsiveness[cep@ror] using Schnider versus Eleveldmodels of propofol
时间窗: After induction at 0 min | Can be variable according to patients
target controlled infusion anaesthesia in adult bariatric surgery.
时间窗: After induction at 0 min | Can be variable according to patients
次要结局
- mean effective concentration of propofol at loss of responsiveness(At the time of induction at 0 min)
研究者
Madhu Meena
Lady Hardinge Medical College
