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临床试验/NCT07237477
NCT07237477
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Comparison of the Site Effect Model Prediction and BIS Predicted by Eleveld for Propofol in Slow and Rapid Inductions

Pablo O. Sepulveda1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年1月15日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Pablo O. Sepulveda
入组人数
70
试验地点
1
主要终点
Prediction of the efect site propofol Eleveld model

概览

简要总结

Patients ASA1-2, 18 to 70 years old, scheduled for elective surgery with personal conset to participate, will be randomised into two groups using different induction mode. TCI effect site mode induction or TCI plasma mode induction both using the Elevelt PKPD propofol model. Standard monitoring (EKG, SaO2, PCo2et, NIAP), and Conox/ and or BIS EEG monitor to evaluate the prediction.

The model's prediction will be compared with values provided by the Conox/BIS index for both groups and between them. The study will be conducted during the 20 minutes after Loss of responsiveness.

详细描述

Patients aged 18 to 70 years will be included. Patients allergic to propofol are excluded. Eleveld's PKPD model for propofol includes covariates for adjustment in administration with target-controlled infusion pumps. Induction to the site of effect will be performed using EC60 for each age, while slow induction will use the target plasma modality, starting at a target of 3 ug/ml and increasing by 0.5 ug/ml every 3 minutes until loss of consciousness. This is defined as the loss of response to voice and shoulder tap. The 20 minutes following loss of consciousness will be evaluated.

Biometric and gender characteristics of both groups, concomitant pathologies, and surgical times will be compared.

The temporal evolution of the propofol effect site predicted by the Eleveld model will be compared between the two types of induction using EEG (CONOX or BIS). To obtain the EEG index prediction by Eleveld it will be use the Tiva trainer software 2.0, simulating the evolution of the kinetics and effect site calculated by Eleveld in the infudion TCI pumps.

It is estimated that 20 patients per group are required to find a 20% difference in predicted versus actual EEG index with 90% power.

Statistical methods:

  1. Data analysis tool: Stata 10 software
  2. Statistics
  • Summary: Mean (central tendency) and standard deviation (dispersion)
  • Association: Student's t-test for continuous quantitative variables and Fisher's exact test for dichotomous variables.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 ASA 1-2 scheduled for elective surgery,

排除标准

  • patients with psychiatric disorders, allergic to propofol, not giving their consent to participate

研究组 & 干预措施

Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction

Patients ASA 1-2, 18 to 70 years, will be induced using propofol TCI in effect site mode EC60 of the Eleveld PKPD model and compared with the EEG CONOX behavior, If lost of responsiveness (LOR) was not reached, we climb up 0,5 ug/ml every 3 min. At LOR calculated effect site concentration will be used as reference to mantain anesthesia level.

干预措施: Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction (Drug)

Group 2: the prediction of the Eleveld propofol model in TCI plasma mode

Patients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour. Induced with TCI plasma mode using the Eleveld PKPD model. The infusion will begin using a target plasma of 3 ug/ml, and scale every 3 minutes in 0,5 ug/ml until Loss of responsiveness (LOR). At LOR the calculated effect site concentration will be used as reference to mantain anesthesia level. EEG (CONOX or BIS) will be used to evaluate the prediction of the model.

干预措施: Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction (Drug)

结局指标

主要结局

Prediction of the efect site propofol Eleveld model

时间窗: The data will be retrieved directly from the infusion pumps and EEGs up to 20 minutes after the loss of clinical consciousness.

The comparison betwen predicted and actual CONOX/BIS index will be made in two scenario: TCI effect site mode induction versus TCI plasma mode induction

次要结局

未报告次要终点

研究者

发起方
Pablo O. Sepulveda
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pablo O. Sepulveda

Dr. Med.

Universidad del Desarrollo

研究点 (1)

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