Postoperative Cognitive DysfunctionPhase 4NCT04541823
The Effect of Desflurane on Postopertative Cognitive Dysfunction
A Phase 4 study testing Desflurane and Propofol in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Desflurane and Propofol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to Mar 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Written consent given
- 2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
- 3. ASA Physical Score I-III
Who cannot join
- 1. Patients with a history of neurological disease, such as Alzheimer disease.
- 2. Patients with a history of psychiatric disease
- 3. Patients with a medication history of antipsychotic drugs.
- 4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
- 5. Patients with preoperative delirium.
- 6. Patients who have severe adverse events, such as cardiac arrest.
- 7. Patients who preoperative MMSE score are below 20;
- 8. Patients who undergo second operation in a short period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Anshi Wu, MD, +8685231330, wuanshi1965@163.com
Anshi Wu, MD
About this study
Official title: A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction
Read the detailed description
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.
Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.
- Being tested
- Desflurane, Propofol
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
PropofolDrug
Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Experimental | Patients allocated to this arm will receive desflurane during the maintenance of anesthesia. Receives: Drug: Desflurane |
| Propofol | Placebo comparator | Patients allocated to this arm will receive propofol during the maintenance of anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction
Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery
Measured: on the 30th day after surgery
Secondary outcomes (9)
Incidence of postoperative delirium
Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Measured: 1-7days after surgery, on the 30th day after surgery
Postoperative Pain
Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
Measured: Within 3 days after surgery
EEG frequency spectrum
Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB:
- Five minutes before anesthesia introduction
- During the entire operation
- At discharge from post-anesthesia care unit (PACU)
Measured: 5 minutes before anesthesia introduction to 5 minutes before discharge from PACU
Mortality
Measured: Within 30 days after surgery
Length of Hospital stay
Measured: From the date of admission until discharged from hospital, within 30 days
Hospital readmission
Hospital readmission during the follow up
Measured: Within 30 days after surgery
Incidence of postoperative nausea and vomiting
Measured: Within 7 days after surgery
Adverse events
Other adverse events within 3 days after surgery were noted
Measured: Within 30 days after surgery
Neural and hemodynamic responses during desflurane general anesthesia
Functional near-infrared spectroscopy (fNIRS) will be monitored from pre-anesthesia to the emergence. △[HbO] ，△[Hb] will be recorded. Besides, the coupling of fNIRS signals with neuronal signals (EEG) will be calculated. Furthermore, sample entrophy and the phase difference between △[HbO] and △[Hb] will be measured.
Measured: 5 minutes before anesthesia introduction to 5 minutes after emergence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 May 2021
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anshi Wu, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541823
- Sponsor's protocol ID
- 00375928
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2020
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT04541823
- Acronym / sponsor ID
- 00375928
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 9 Sep 2020 (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 purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction
Detailed description
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.
Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Experimental | Drug: DesfluranePatients allocated to this arm will receive desflurane during the maintenance of anesthesia. |
| Propofol | Placebo comparator | Drug: PropofolPatients allocated to this arm will receive propofol during the maintenance of anesthesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 1. Written consent given
- 2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
- 3. ASA Physical Score I-III
Key exclusion criteria (8 listed)
- 1. Patients with a history of neurological disease, such as Alzheimer disease.
- 2. Patients with a history of psychiatric disease
- 3. Patients with a medication history of antipsychotic drugs.
- 4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
- 5. Patients with preoperative delirium.
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 |
|---|---|---|
| DesfluraneInvestigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia | Drug | Desflurane |
| PropofolInvestigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia | Drug | Propofol |
Primary outcome
Incidence of postoperative cognitive dysfunction
Time frame: on the 30th day after surgery
Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery
9 secondary outcomes
Incidence of postoperative delirium
Time frame: 1-7days after surgery, on the 30th day after surgery
Postoperative Pain
Time frame: Within 3 days after surgery
EEG frequency spectrum
Time frame: 5 minutes before anesthesia introduction to 5 minutes before discharge from PACU
Mortality
Time frame: Within 30 days after surgery
Length of Hospital stay
Time frame: From the date of admission until discharged from hospital, within 30 days
Hospital readmission
Time frame: Within 30 days after surgery
Incidence of postoperative nausea and vomiting
Time frame: Within 7 days after surgery
Adverse events
Time frame: Within 30 days after surgery
Neural and hemodynamic responses during desflurane general anesthesia
Time frame: 5 minutes before anesthesia introduction to 5 minutes after emergence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane and Propofol in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by Beijing Chao Yang Hospital at 1 site in China.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cognitive dysfunction (time frame: on the 30th day after surgery). 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 19 Aug 2021.