Postoperative Cognitive DysfunctionPhase 2NCT03914118
Modafinil to Prevent Postoperative Cognitive Decline
A Phase 2 study testing Preoperative modafinil + postoperative modafinil in people with Postoperative Cognitive Dysfunction, run by The Cooper Health System.
Trial summary
Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Preoperative modafinil + postoperative modafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Jan 2013
- Phase
- Phase 2
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- American Society of Anesthesiologists class I or II
- Elective surgery
- Surgery requiring general anesthesia
- 4.) Control Group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.
Who cannot join
- Neurosurgery
- Cardiac surgery
- Narcotic or illicit drug abuse
- Chronic opioid use
- Chronic use of anxiolytics
- History of pulmonary disease
Show all 9Show fewer
- C02 retention
- Sleep apnea
- Obesity
About this study
Official title: An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population
Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Preoperative modafinil + postoperative placebo, Preoperative modafinil + postoperative modafinil, Preoperative placebo + postoperative placebo
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative modafinil + postoperative placeboDrug
200 mg modafinil pre-operatively and placebo immediately post-operatively.
Preoperative modafinil + postoperative modafinilDrug
200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
Preoperative placebo + postoperative placeboDrug
Placebo pre-operatively and placebo immediately post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative modafinil + postoperative placebo | Active comparator | Not described Receives: Drug: Preoperative modafinil + postoperative placebo |
| Preoperative modafinil + postoperative modafinil | Active comparator | Not described Receives: Drug: Preoperative modafinil + postoperative modafinil |
| Preoperative placebo + postoperative placebo | Placebo comparator | Not described Receives: Drug: Preoperative placebo + postoperative placebo |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning Test (RAVLT) scores
Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms.
The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jan 2008
- Primary completion31 Jan 2013
- Study completion31 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronak Desai, DO, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914118
- Sponsor's protocol ID
- 08-086
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2019
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population
- ClinicalTrials.gov ID
- NCT03914118
- Acronym / sponsor ID
- 08-086
- Conditions
- Postoperative Cognitive Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Jan 2013 (actual)
- Study completion
- 31 Jan 2013 (actual)
- First posted
- 16 Apr 2019 (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.
Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preoperative modafinil + postoperative placebo | Active comparator | Drug: Preoperative modafinil + postoperative placebo |
| Preoperative modafinil + postoperative modafinil | Active comparator | Drug: Preoperative modafinil + postoperative modafinil |
| Preoperative placebo + postoperative placebo | Placebo comparator | Drug: Preoperative placebo + postoperative placebo |
| Control group | No intervention | – |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists class I or II
- Elective surgery
- Surgery requiring general anesthesia
- 4.) Control Group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.
Key exclusion criteria (9 listed)
- Neurosurgery
- Cardiac surgery
- Narcotic or illicit drug abuse
- Chronic opioid use
- Chronic use of anxiolytics
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 |
|---|---|---|
| Preoperative modafinil + postoperative placebo200 mg modafinil pre-operatively and placebo immediately post-operatively. | Drug | Preoperative modafinil + postoperative placebo |
| Preoperative modafinil + postoperative modafinil200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively. | Drug | Preoperative modafinil + postoperative modafinil |
| Preoperative placebo + postoperative placeboPlacebo pre-operatively and placebo immediately post-operatively. | Drug | Preoperative placebo + postoperative placebo |
Primary outcome
Rey Auditory Verbal Learning Test (RAVLT) scores
Time frame: 3 months
Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms. The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively.
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 29 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Preoperative modafinil + postoperative modafinil in people with Postoperative Cognitive Dysfunction, run by The Cooper Health System.
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 4 inclusion and 9 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 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rey Auditory Verbal Learning Test (RAVLT) scores (time frame: 3 months). 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 29 Sep 2023.