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Completed

NCT Number: NCT03132168

Postoperative Delirium in Patients Undergoing Radical Cystectomy

In this study, post-operative delirium will be measured in patients undergoing surgery for bladder resection, and associated microRNA biomarkers will be evaluated in patients considered delirious and non-delirious after surgery.

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Key information

Conditions

Post-operative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

With voluntary participation, this study requires participants to complete a self-administered cognitive evaluation (SAGE) before surgery to assess baseline cognitive impairment and early dementia; vital signs will be documented prior to surgery. During surgery, participants will receive a standardized general anesthesia regimen as described in the protocol. Several parameters will be measured during surgery, including bispectral monitoring to measure processed EEG. After surgery, fitness for cognitive evaluation will be determined by the Richmond Agitation-Sedation Scale (RASS) scale, and then emergence delirium will be assessed using the CAM-ICU scale. Fitness for discharge from PACU will be determined by an Aldrete score of 9 or more. Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS-11). Postoperative nausea and vomiting (PONV) level will also be documented. Postoperative Delirium (POD) assessment will be achieved by administering the memorial delirium assessment scale (MDAS) twice a day starting on day 1 through day 3 postoperatively. Pain NRS-11 score and PONV levels will also be documented at each visit. For microRNA testing, blood probes will be collected in 5mL purple top tube at surgical preadmission and post-surgery days one, two and three. Risks associated with participating in this study include normal risk associated with having surgery and general anesthesia; no greater than minimal risk is associated with blood collection. For the participant, there are no immediate anticipated benefits for participating in this study. The importance of the knowledge that is expected to result includes lower post-operative complications as a result of post-operative delirium, faster recovery, and shorter hospital stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age and older
  • ASA II or III
  • Capable of and willing to consent
  • Participants literate in English language

Exclusion criteria

  • ASA IV or V
  • Patients with severe visual or auditory impairment
  • Inability to read and/or write in English
  • Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia
  • Dementia of Alzheimer's type
  • Parkinson's disease
  • Multiple Sclerosis (MS)
  • Vascular dementia

Treatment and study plan

Assessments

Behavioral

These cognitive assessments will be utilized during the study to evaluate cognitive levels comparing prior to surgery and post-operatively in order to determine if the subject is delirious. BIS monitoring will be utilized for all subjects.

Other names: SAGE scale, Memorial Delirium Assessment Scale

Blood draw

Procedure

Subjects will have blood draws at surgical preadmission visit, Day 1, Day 2, and Day 3 post surgery only; one tube containing approximately one teaspoon (5 mL) of blood will be drawn at each visit.

Standardized Anesthetic Care

Other

Standardized anesthetic care will be provided as described by the protocol for each subject consented for this trial.

Other names: Anesthetic Regimen

Primary outcomes

  1. Post-operative delirium

    Time frame: up to 3 days post-operatively

    Evaluate the incidence of and risk factors for POD in patients undergoing radical cystectomy utilizing the Memorial Delirium Assessment Scale.

Secondary outcomes

  1. microRNA expression

    Time frame: up to 3 days post-operatively

    A secondary aim of the study is to obtain estimates and variances of the difference in microRNA expression between 2 groups: delirious patients and non-delirious patients.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2017
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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