NCT06435247 The Effect of Accompaniment by Older Adults on Anesthetic Recovery
| NCT ID | NCT06435247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | American British Cowdray Medical Center |
| Condition | Elderly |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2024-07-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mariana Garcia, investigator
PRINCIPAL INVESTIGATOR
American British Cowdray Medical Center
Frequently Asked Questions
Who can join the NCT06435247 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Elderly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06435247 currently recruiting?
Yes, NCT06435247 is actively recruiting participants. Contact the research team at mariana.26_11@hotmail.com for enrollment information.
Where is the NCT06435247 trial being conducted?
This trial is being conducted at Mexico City, Mexico, Mexico City, Mexico.
Who is sponsoring the NCT06435247 clinical trial?
NCT06435247 is sponsored by American British Cowdray Medical Center. The principal investigator is Mariana Garcia, investigator at American British Cowdray Medical Center. The trial plans to enroll 240 participants.