The Effect of Accompaniment by Older Adults on Anesthetic Recovery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAmerican British Cowdray Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA (American society of anesthesiologist) I y II

Education level Hight school or higher

Disqualifiers

History of diseasses associated with dementia

Emergency surgery.

Regional anesthesia or sedation

Moderate to severe cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • With or without accompaniment in the recovery anaesthetic area

    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

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Accompaniment in the recovery areaExperimental treatment 1 intervention
Group B: without accompanimentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Within 24 hours followin the surgical procedure

Secondary outcomes

1

Anxiety in both groups measured using the Beck Anxiety Scale

Anxiety will be measured in both groups: the intervetion grup and the control grup. This assessment will occur at two time points

Time frame
Before the surgical procedure and 24 hors after the surgical event
2

Delirium

Delirium will be measured in the two grups at 3 times points post surgery

Time frame
24 hours, day 5 and day 30.

Other outcomes

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