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临床试验/NCT06435247
NCT06435247招募中不适用

The Effect of Accompaniment by Older Adults on Anaesthetic Recovery

American British Cowdray Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
2
主要终点
The best score in the QoR15 (Quality of recovery-15) scale greater than 122

研究概览

简要总结

Summary:

In 2022, Mexico estimated a population of 17,958,707 older adults. With increased life expectancy, it is essential to seek strategies that improve the health of this population, as they are more vulnerable compared to other age groups due to functional and cognitive decline, along with an increase in chronic diseases and medication intake. During this stage of life, there is a possibility of requiring surgical treatment, which is the focus of this protocol proposing a maneuver that impacts patients' health without requiring economic costs. The proposal suggests the accompaniment of older adults by a family member during the immediate post-anesthetic period. Hypothesis: Accompaniment of older adults during the immediate postoperative period improves the quality of anesthetic recovery by 60%. This value is based on a study by Shem, where accompanying older adults prior to anesthetic induction resulted in a 61% reduction in anxiety among older adults. Anesthesiologists have expanded their role in perioperative medicine alongside geriatric medicine services for older surgical patients.

An experimental study will be conducted with two randomly divided groups: one group with accompaniment and one group without accompaniment in the recovery area. Both groups will be assessed using different questionnaires: 1. Pfeiffer Test for cognitive impairment diagnosis, 2. QoR-15 to assess the quality of anesthetic recovery, 3. Beck Anxiety Questionnaire, all of which will be administered 24 hours after surgery. Delirium will also be assessed using NuDESC at 24 hours, day 5, and 30 days after surgery. General data prior to surgery will be recorded, and vital signs such as heart rate, blood pressure, and pain on a verbal scale from 0 to 10 will be monitored during the postoperative period.

Statistical analysis will involve representing baseline characteristics of the population using mean and standard deviation or median and interquartile range, depending on the distribution type. X2 will be used to compare both groups in terms of outcomes. Finally, a multivariate analysis will be conducted using logistic regression to adjust for confounding variables.

详细描述

Justification:

Due to the increase in life expectancy and the growing number of older adults worldwide and in our country, it is important to search for and implement feasible and cost-free measures to improve the quality of medical care, specifically in surgical treatments that impact the reduction of complications, shorten recovery time, and indirectly improve the quality of life for these patients.

Feasibility and relevance:

  • The research question aims to improve the quality of medical care for older adults with a humanistic approach.
  • In a group of people that will continue to grow, with a longer life expectancy, they will require surgical treatments.
  • There are no articles evaluating the quality of anesthetic recovery or its impact on their health with accompaniment.
  • Approximately 222 surgeries are performed in this population every month, making it a frequent occurrence.
  • It is a measure that does not incur any cost.
  • It can be applied in any hospital setting.

Problem statement:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Scheduled for elective surgery under balanced anesthesia with a hospital stay not exceeding 48 hours.
  • •ASA (American society of anesthesiologist) I y II
  • •Education level Hight school or higher

排除标准

  • •History of diseasses associated with dementia
  • •Emergency surgery.
  • •Regional anesthesia or sedation
  • •Moderate to severe cognitive impairment
  • •History of smoking or drugs
  • •Surgerios with risk of major bleeding more or equal 1000ml
  • •Hip or long bone surgeries

研究组 & 干预措施

Accompaniment in the recovery area

Experimental

The first group will have a family member accompany them in the recovery area

干预措施: With or without accompaniment in the recovery anaesthetic area (Behavioral)

without accompaniment

No Intervention

The second group will not have accompaniment as is currently standard practice

结局指标

主要结局

The best score in the QoR15 (Quality of recovery-15) scale greater than 122

时间窗: Within 24 hours followin the surgical procedure

The goal is to evaluate the impact of this accompainment on enhancing the quality of patients anesthetic recovery, as measured by the QoR15 scale

次要结局

  • Anxiety in both groups measured using the Beck Anxiety Scale(Before the surgical procedure and 24 hors after the surgical event)
  • Delirium(24 hours, day 5 and day 30.)

研究者

发起方
American British Cowdray Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Guadalupe García Hernandez

Physician investigator

American British Cowdray Medical Center

研究点 (2)

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