The Effect of Accompaniment by Older Adults on Anesthetic Recovery

NCT06435247 | Recruiting DMC

• 1 other identifier: CMABC-24-18
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Elderly; Anesthesia; Reaction

Keywords

ancianos; añadir la calidad de la recuperación anestésica; añadir acompañamiento

Outcome Measures

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

  Within 24 hours followin the surgical procedure

Secondary Outcomes (2)

• 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.

Study Arms (2)

Accompaniment in the recovery area

EXPERIMENTAL

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

Behavioral: With or without accompaniment in the recovery anaesthetic area

without accompaniment

NO INTERVENTION

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

Interventions

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

Accompaniment in the recovery area

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American British Cowdray Medical Center: lead

Study Sites (2)

El Centro Médico American Brithish Cowdray, I.A.P

Mexico City, 01120, Mexico

RECRUITING

Centro Médico ABC

Mexico City, 05348, Mexico

RECRUITING

Study Officials

• Mariana Garcia, investigator

  American British Cowdray Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana Garcia, investigator

CONTACT

+525541922325; mariana.26_11@hotmail.com

Juan Talavera, consultant

CONTACT

jotalaverap@abchospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician investigator

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-07

Locations

ME (2)