- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02109081
Dexamethasone and Postoperative Delirium
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be a randomized, placebo-controlled, double blind clinical investigation. Four hundred patients scheduled for surgical procedures under general anesthesia will be enrolled. Patients will be randomized via a computerized randomization table to one of two groups; a dexamethasone group (10 mg of dexamethasone in a 5 cc syringe) or a control group (an equal volume of saline in a 5 cc syringe)). A dose of 10 mg of dexamethasone was selected, as this reflects a dose that has been demonstrated to attenuate the inflammatory response to surgery, decrease pain, and improve clinical recovery. This is also within the dose range commonly used at NorthShore University HealthSystem. The drug/placebo solution will be prepared by the pharmacy into the syringes. Both solutions are clear and appear identical. Study syringes will be prepared by the pharmacy, and all clinicians will be blinded to group assignment. At the induction of anesthesia, the syringe containing either dexamethasone or saline will be administered. The administration of all other anesthetic agents will be standardized and reflect the usual practices of anesthesiologists at NorthShore University HealthSystem.
Monitoring will consist of standard American Society of Anesthesiologists monitors, which include manual blood pressure measurements, continuous EKG monitoring, pulse oximetry, capnography and infrared gas analysis. Additional monitoring, such as direct radial artery pressure measurements, will be at the discretion of the attending anesthesiologist. Anesthetic induction will consist of propofol 0.5-2.0 mg/kg, fentanyl 50-100 μg, and rocuronium 0.6 mg/kg. Anesthesia will be maintained with sevoflurane 0.5-3.0%, with the concentration of inhalational agent adjusted to maintain blood pressure within 20-30% of baseline values and depth of anesthesia standardized using a BIS monitor (BIS values 40-60). Additional doses of fentanyl, up to 1-2 µg/kg/hour, can be administered at the discretion of the anesthesia care provider. Hydromorphone may be provided for postoperative analgesia. Hypotension (any decrease in mean arterial pressure ≥ 20%) will be treated with a fluid bolus, phenylephrine, or ephedrine, as clinically indicated. Thirty minutes before the anticipated conclusion of the surgical procedure, patients will receive ondansetron 4 mg. Neuromuscular blockade will be reversed with neostigmine and glycopyrrolate.
Patients will be managed according to standard PACU protocols. Nausea and vomiting will be treated per standard protocols. Any episodes of nausea and vomiting in the PACU will be noted on a data collection sheet. Pain will be treated with hydromorphone. Pain scores in the PACU, as well as total doses of hydromorphone will be recorded. Patients will be discharged from the PACU when standard criteria are met. Study subjects will be discharged either to the surgical floor or the intensive care unit (ICU). The times to meet discharge criteria and actually achieve discharge will be recorded. For patients transferred directly to the ICU from the operating room, nausea, vomiting, pain scores, and analgesic requirements will be collected over the first 3 hours of recovery. Postoperatively, pain will be controlled with intravenous doses of hydromorphone. Intravenous analgesia will be provided until patients are able to resume oral intake, which usually occurs on the first or second postoperative day. At this time, analgesic management will be transitioned to oral pain medication (typically hydrocodone 5 mg / acetaminophen 500 mg). Total doses of intravenous and oral pain medications will be recorded during the hospitalization. Postoperative pain scores will be assessed at the same time testing for delirium is performed during the postoperative period. A planned interim analysis will be performed when 200 patients are enrolled
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60201
- NorthShore University Healthsystem
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients ≥ 70 years of age, undergoing a noncardiac surgical procedure under general anesthesia, with an anticipated duration of postoperative admission of at least 2 days.
Exclusion Criteria:
- 1) preoperative diagnosis of delirium or dementia; 2) MMSE score of ≤ 20 out of 30 on preoperative testing (more than mild cognitive impairment) or delirium on preoperative CAM testing; 3) language barriers that would preclude testing; 4) preoperative steroid use within 3 days of surgery; or 5) anticipation of postoperative intubation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexamethasone
Patients will be administered dexamethasone 10 mg at induction of anesthesia
|
|
Placebo Comparator: Placebo-2.5 cc of saline
Patients will be administed placebo at induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative delirium at postanesthesia care unit (PACU) discharge
Time Frame: 45 minutes after PACU admission
|
The Confusion Assessment Method (CAM) test will be used to determine the presence or absence of delirium.
The CAM assesses the acute onset and attention deficits as primary features, and level of consciousness and disorganized thinking as secondary features.
In order to measure the primary and secondary components of the CAM, additional formal testing is required; the Mini Mental State Exam (MMSE) will be used.
|
45 minutes after PACU admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative delirium day one
Time Frame: 24 hours after surgery
|
The Confusion Assessment Method (CAM) test will be used to determine the presence or absence of delirium.
The CAM assesses the acute onset and attention deficits as primary features, and level of consciousness and disorganized thinking as secondary features.
In order to measure the primary and secondary components of the CAM, additional formal testing is required; the Mini Mental State Exam (MMSE) will be used.
|
24 hours after surgery
|
Postoperative delirium day two
Time Frame: 48 hours after surgery
|
The Confusion Assessment Method (CAM) test will be used to determine the presence or absence of delirium.
The CAM assesses the acute onset and attention deficits as primary features, and level of consciousness and disorganized thinking as secondary features.
In order to measure the primary and secondary components of the CAM, additional formal testing is required; the Mini Mental State Exam (MMSE) will be used.
|
48 hours after surgery
|
MMSE scores at postanesthesia care unit discharge
Time Frame: 45 minutes after PACU admission
|
The Mini Mental State Exam (MMSE) is an easy to use test of cognitive function that can be administered in 5-10 minutes.
It was specifically developed to screen for dementia, with scores of ≤ 20 out of 30 indicating moderate cognitive dysfunction.
|
45 minutes after PACU admission
|
MMSE on postoperative day one
Time Frame: 24 hours after surgery
|
The Mini Mental State Exam (MMSE) is an easy to use test of cognitive function that can be administered in 5-10 minutes.
It was specifically developed to screen for dementia, with scores of ≤ 20 out of 30 indicating moderate cognitive dysfunction.
|
24 hours after surgery
|
MMSE on postoperative day two
Time Frame: 48 hours after surgery
|
The Mini Mental State Exam (MMSE) is an easy to use test of cognitive function that can be administered in 5-10 minutes.
It was specifically developed to screen for dementia, with scores of ≤ 20 out of 30 indicating moderate cognitive dysfunction.
|
48 hours after surgery
|
Hospital length of stay
Time Frame: 5 days
|
The total length of the hospitalization will be recorded
|
5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Delirium
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- EH13-477
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States