The Effect of Accompaniment by Older Adults on Anesthetic Recovery (AAR)

August 24, 2024 updated by: Mariana Guadalupe García Hernandez, American British Cowdray Medical Center

The Effect of Accompaniment by Older Adults on Anaesthetic Recovery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Accompaniment in the recovery area
The first group will have a family member accompany them in the recovery area
Behavioral: 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
No Intervention: without accompaniment
The second group will not have accompaniment as is currently standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The best score in the QoR15 (Quality of recovery-15) scale greater than 122
Time Frame: 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
Within 24 hours followin the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety in both groups measured using the Beck Anxiety Scale
Time Frame: Before the surgical procedure and 24 hors after the surgical event
Anxiety will be measured in both groups: the intervetion grup and the control grup. This assessment will occur at two time points
Before the surgical procedure and 24 hors after the surgical event
Delirium
Time Frame: 24 hours, day 5 and day 30.
Delirium will be measured in the two grups at 3 times points post surgery
24 hours, day 5 and day 30.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American British Cowdray Medical Center

Investigators

  • Principal Investigator: Mariana Garcia, investigator, American British Cowdray Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMABC-24-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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