The Effect of Accompaniment by Older Adults on Anesthetic Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Automated Administration of Intravenous Compared With Inhalatory Anesthesia on the Occurrence of Postoperative Delirium

NCT03705728

Postoperative Delirium Elderly Patient General Anesthetic Drug Adverse Reaction

UNKNOWN NA

Educating Anesthesia Residents to Improve Perioperative Care for the Elderly

NCT03008863

Anesthesia

COMPLETED NA

Functional Recovery and Caregiver Burden Following Surgery in the Elderly

NCT01382251

Activities of Daily Living Caregivers Ambulatory Surgical Procedures

COMPLETED

The Study of Anesthesia-related Risk Factors for Postoperative Death in Elderly Non-cardiac Surgery Patients in China

NCT04389008

Postoperative Mortality Anesthesia Elderly Patients +1 more

UNKNOWN

Use of Anesthetic Block for the Prevention of in Hospital Delirium in Patients of the Orthogeriatric Clinical Care Center of the HUFSFB and HUSJI From 2019 - 2020

NCT04654962

Delirium in Old Age Fragility Fracture Hip Fractures

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

The increase in life expectancy worldwide has led to a larger population of older adults, and Mexico is no exception. Therefore, it is important to establish measures that improve the quality of medical care and reduce complications in this age group, using measures that do not incur any economic costs. Specifically, in the perioperative period, proposing the accompaniment of older adults in the anesthetic recovery area.

Research question:

Does the accompaniment of older adults improve the quality of anesthetic recovery with a score higher than 122 on the QoR15 (quality of recovery - 15) scale?

Hypotheses:

Null hypothesis:

The accompaniment of older adults in the immediate postoperative period does not improve the quality of anesthetic recovery with a score lower than 121 on the QoR15 scale.

Alternative hypothesis:

The accompaniment of older adults in the immediate postoperative period improves the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale.

Overall objective:

\- Determine if the accompaniment of older adults improves the quality of anesthetic recovery, classified as good or excellent according to the QoR15 scale with a score of 122 to 150.

Specific objectives:

* Determine the incidence of anxiety in older adults in the anesthetic recovery area, considering anxiety with a score higher than 22 on the Beck scale.
* Determine the presence or absence of delirium in older adults in the perioperative period.
* Assess if the accompaniment of older adults reduces the length of stay in the anesthetic recovery area, aiming for a stay of no more than 60 minutes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Anesthesia; Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized clinical trial design with two groups

* One group will have family accompaniment in the recovery area, the other will not
* The QoR-15 scale will be used to measure the quality of anesthetic recovery
* The randomization was done using the OpenEpi software

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Accompaniment in the recovery area

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

Group Type EXPERIMENTAL

With or without accompaniment in the recovery anaesthetic area

Intervention Type BEHAVIORAL

one grup will have family accompaniment in the recovery area and the other group will not in both groups the QoR15 scale will be used to measure the quality of anesthetic recovery

without accompaniment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

With or without accompaniment in the recovery anaesthetic area

one grup will have family accompaniment in the recovery area and the other group will not in both groups the QoR15 scale will be used to measure the quality of anesthetic recovery

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ASA (American society of anesthesiologist) I y II
* Education level Hight school or higher

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes