DeliriumNCT03541408
Preventative Delirium Protocol in Elderly Patients
A study testing Preventative Delirium Protocol in people with Delirium, run by Rush University Medical Center at 1 site in United States.
Trial summary
The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Preventative Delirium Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 65 years
- Scheduled for Elective Surgery (outpatient/same-day admit)
Who cannot join
- Need emergency surgery
- Need intracranial surgery
- Dependent on opiate narcotics
- Surgeon-specified perioperative procedures that precludes the current study's protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Randomized, Controlled Trial Reviewing the Effectiveness of a Preventative Delirium Protocol in Elderly Patients While Analyzing Its Consequential Effects on Awareness, PONV, and/or Pain Control
The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.
Read the detailed description
A comprehensive analysis of patient specific risk factors and predisposing perioperative risk factors will be completed. The objective is to see if delirium incidences are significantly lower in the group that receives a preventative delirium protocol compared to a control group, while not increasing other adverse undesirable side effects. We hypothesize that a preventative delirium protocol will reduce the incidence of delirium compared to the control group (primary outcome), but this protocol may lead to increased side effects such as PONV, poor pain control, and increased awareness (secondary outcomes).
- Conditions
- Delirium
- Being tested
- Control, Preventative Delirium Protocol
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Standard Of Care without Preventative Delirium Protocol
Preventative Delirium ProtocolOther
Preventative Delirium Protocol
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Subjects will receive anesthesia Receives: Other: Control |
| Preventative Delirium Protocol | Experimental | * Consider regional block if applicable
* Minimized fentanyl usage intraoperatively
* Intubation + GA adjunct total: 1-2 mcg/kg
* Sedation: 0-0.25 mcg/kg
* Post-op: 0.5-1 mcg/kg
* Avoid morphine
* Avoid ketamine
* Avoid diphenhydramine, dexamethasone, scopolamine, metoclopramide, and promethazine
* Avoid H2-blockers (cimetidine, ranitidine, famotidine)
* Avoid polypharmacy intraoperatively if possible (i.e. >5 new medications)
* Fluid repletion based on maintenance and losses Receives: Other: Preventative Delirium Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of Delirium (CAM_ICU)
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure
Measured: Within one post-operative day
Secondary outcomes (2)
PONV
Post-operative Nausea and Vomiting
Measured: Within one post-operative day
NRS Pain
Numerical Rating Scale of Pain Intensity, 0 - 10 scale. Value of 0 is No Pain. Value of 10 is Worst Pain Imaginable.
Measured: Within one post-operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 May 2016
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asokumar Buvanendran, Rush University Medical Center
- Investigators
- Asokumar Buvanendran, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541408
- Sponsor's protocol ID
- Delirium
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2017
- Last updated
- 12 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data to be shared by contacting the primary investigator and executing a data use agreement with Rush University
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Reviewing the Effectiveness of a Preventative Delirium Protocol in Elderly Patients While Analyzing Its Consequential Effects on Awareness, PONV, and/or Pain Control
- ClinicalTrials.gov ID
- NCT03541408
- Acronym / sponsor ID
- Delirium
- Conditions
- Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to elucidate the effectiveness of a preventative delirium protocol in patients older than 65 years of age undergoing elective surgery.
Detailed description
A comprehensive analysis of patient specific risk factors and predisposing perioperative risk factors will be completed. The objective is to see if delirium incidences are significantly lower in the group that receives a preventative delirium protocol compared to a control group, while not increasing other adverse undesirable side effects. We hypothesize that a preventative delirium protocol will reduce the incidence of delirium compared to the control group (primary outcome), but this protocol may lead to increased side effects such as PONV, poor pain control, and increased awareness (secondary outcomes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlSubjects will receive anesthesia |
| Preventative Delirium Protocol | Experimental | Other: Preventative Delirium Protocol* Consider regional block if applicable * Minimized fentanyl usage intraoperatively * Intubation + GA adjunct total: 1-2 mcg/kg * Sedation: 0-0.25 mcg/kg * Post-op: 0.5-1 mcg/kg * Avoid morphine * Avoid ketamine * Avoid diphenhydramine, dexamethasone, scopolamine, metoclopramide, and promethazine * Avoid H2-blockers (cimetidine, ranitidine, famotidine) * Avoid polypharmacy intraoperatively if possible (i.e. >5 new medications) * Fluid repletion based on maintenance and losses |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 65 years
- Scheduled for Elective Surgery (outpatient/same-day admit)
Key exclusion criteria (4 listed)
- Need emergency surgery
- Need intracranial surgery
- Dependent on opiate narcotics
- Surgeon-specified perioperative procedures that precludes the current study's protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlStandard Of Care without Preventative Delirium Protocol | Other | Control |
| Preventative Delirium ProtocolPreventative Delirium Protocol | Other | Preventative Delirium Protocol |
Primary outcome
Presence or absence of Delirium (CAM_ICU)
Time frame: Within one post-operative day
Delirium defined by Post-operative CAM, using the validated CAM-ICU measure
2 secondary outcomes
PONV
Time frame: Within one post-operative day
NRS Pain
Time frame: Within one post-operative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: Yes. IPD data to be shared by contacting the primary investigator and executing a data use agreement with Rush University
Related trials for Delirium
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
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Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asokumar Buvanendran, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventative Delirium Protocol in people with Delirium, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of Delirium (CAM_ICU) (time frame: Within one post-operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.