## Protocol Section
### Identification Module
**NCT ID:** NCT06435247

**Acronym:** AAR

**Brief Title:** The Effect of Accompainment by Older Adults on Anesthetic Recovery

**Official Title:** The Effect of Accompainment by Older Adults on Anaesthetic Recovery

#### Organization Study ID Info
**ID:** CMABC-24-18
#### Organization
**Class:** OTHER
**Full Name:** American British Cowdray Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** American British Cowdray Medical Center

#### Responsible Party

**Investigator Affiliation:** American British Cowdray Medical Center

**Investigator Full Name:** Mariana Guadalupe García Hernandez

**Investigator Title:** Physician investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**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 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 Module

**Conditions:**

- Old Age; Debility

**Keywords:**

- ederly, quality of anesthetic recovery, accompaniment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: With or without accompainment in the recovery anaesthetic area

**Label:** Accompainment in the recovery area

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The second group will not have accompainment as is currently standard practice

**Label:** without accompainment

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Accompainment in the recovery area

**Description:** one grup will have family accompainment 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

**Name:** With or without accompainment in the recovery anaesthetic area

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** The best score in the QoR15 scale

**Time Frame:** Within 24 hours followin the surgical procedure

#### Secondary Outcomes

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

**Measure:** Anxiety in both groups measured using the Beck Anxiety Scale

**Time Frame:** Before the surgical procedure and 24 hors after the surgical event

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

**Measure:** Delirium

**Time Frame:** 24 hours, day 5 and day 30.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria: Scheduled for elective surgery under balanced anesthesia with a hospital stay not exceeding 48 hours.

* ASA 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

**Healthy Volunteers:** True

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mariana.26_11@hotmail.com

**Name:** Mariana Garcia, investigator

**Phone:** +525541922325

**Role:** CONTACT

**Contact 2:**

**Email:** jotalaverap@abchospital.com

**Name:** Juan Talavera, consultant

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Mexico City

**Contacts:**

***Contact 1:***

- **Email:** mariana.26_11@hotmail.com

- **Name:** Mariana Garcia, Investigator

- **Phone:** +525541922325

- **Role:** CONTACT

***Contact 2:***

- **Email:** jotalaverap@abchospital.com

- **Name:** Juan Talavera, consultor

- **Role:** CONTACT

**Country:** Mexico

**Facility:** The American Brithish Cowdray Medical Center, I.A.P

**Zip:** 01120

#### Overall Officials

**Official 1:**

**Affiliation:** American British Cowdray Medical Center

**Name:** Mariana Garcia, investigator

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M1175

- Name: Frailty

- Relevance: HIGH

- As Found: Debility

### Condition Browse Module - Meshes

- ID: D000073496

- Term: Frailty

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Process

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
