Effect of Sedation on Cognitive Performance in the Elderly

NCT03089866 | Completed DMC FDA Drug

• 1 other identifier: F141022006
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to allow the anesthesiologist to make a more informed decision about the anesthetic requirement of a person prior to starting anesthesia. The preliminary data collected in this study will support a larger investigation aimed at gaining a better understanding of anesthetic susceptibility in general and in the elderly population which appears to be at greater risk for Postoperative Cognitive Dysfunction (POCD) POCD is a short-term decline in cognitive function (especially in memory and executive functions) that may last from a few days to a few weeks after surgery. In rare cases, this disorder may persist for several months after major surgery. POCD is distinct from emergence delirium. It occurs most commonly in older patients and those with pre-existing cognitive impairment. POCD is common in adult patients of all ages at hospital discharge after major non-cardiac surgery, but only the elderly (aged 60 years or older) are at significant risk for long-term cognitive problems. The body's inflammatory response to surgery likely plays an important role, at least in elderly patients. Investigators also postulate that a relative 'anesthetic overdose' may be a significant risk factor. Hence, being able to make a better judgment on the dose needed for an individual is extremely important.

Conditions

Postoperative Cognitive Dysfunction

Keywords

Central nervous System; Memory functions; Executive functions; Cognitive impairment

Outcome Measures

Primary Outcomes (2)

• Effect of a single dose of midazolam on cognitive function.

  Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores before and after sedation

  Baseline to 1hour

• Effect of a single dose of Midazolam on Auditory Activation

  Change in Brain activation before and after sedation

  Baseline to 1 hour

Study Arms (1)

ASA Patients I or II

Participants are healthy (BMI \<35), 55years and older, and have the ability to follow instructions. In this population we will quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).

Drug: Midazolam (0.02mg/kg)

Interventions

Midazolam (0.02mg/kg) DRUG

Quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).

ASA Patients I or II

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants classified by the American Society of Anesthesiologists (ASA) as a Class I or II patient.

You may qualify if:

• Must be a healthy subject
• years and older
• Able to follow study instructions.

You may not qualify if:

• Obesity (BMI \> 35)
• Non-English speaking/reading
• Sleep apnea
• Moderate to severe bronchial asthma
• Cardiovascular problems including hypertension
• History of claustrophobia
• Presence of a pacemaker,
• Defibrillator,
• Any surgically placed metallic object,
• Presence of bullet or shrapnel in the body,
• Presence of a non-removable prosthetic,
• Use of a hearing aid if unable to hear otherwise,
• Head girth exceeding that of the head coil used in the MRI
• Extensive metal work on or in teeth
• Non-removable dentures or bridgework, epilepsy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

Related Publications (4)

• Bryson GL, Wyand A. Evidence-based clinical update: general anesthesia and the risk of delirium and postoperative cognitive dysfunction. Can J Anaesth. 2006 Jul;53(7):669-77. doi: 10.1007/BF03021625.

  PMID: 16803914 BACKGROUND

• Folstein, Marshal F., Susan E. Folstein, and Paul R. McHugh.

  BACKGROUND

• Wickelgren, Wayne A.

  BACKGROUND

• Deary, Ian J., and Geoff Der.

  BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications; Cognitive Dysfunction

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Froelich, MD

  Anesthesiology ad Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 24, 2017
• Study Start: March 1, 2015
• Primary Completion: August 4, 2020
• Study Completion: September 4, 2020
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (1)