Cognition Disorders in Old AgePhase 4POCDLLSNCT03194074
Early Cognitive Function in Elderly Patients After Laser Laryngeal Surgery: Des vs Prop
A Phase 4 study testing Propofol and Desflurane in people with Cognition Disorders in Old Age, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Postoperative cognitive impairment is one of the most common complications in elderly surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognition Disorders in Old Age
- What is being tested?
- Propofol and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to Dec 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for laser laryngeal surgery under general anesthesia with either Propofol or desflurane based technique.
Who cannot join
- Patients with cardiac, pulmonary, hepatic, or renal dysfunction, epilepsy, or uncontrolled hypertension, or those taking medications that influence the central nervous system, are excluded from the study. Patients who show obvious alteration of mental status, or refuse to participate, are also excluded from the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200031
Huawei Li, Phd &MD, hwli@shmu.edu.cn
Lingjie Wu, MS &MD, wulingjie116@163.com
About this study
Official title: Early Cognitive Function and Recovery in Elderly Patients After Laser Laryngeal Surgery: Desflurane-based vs Propofol-based Anesthesia
Postoperative cognitive impairment is one of the most common complications in elderly surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. For elderly patients, because of preoperatively declined cardiovascular and lung function and cognitive function, there is a potential that intraoperative low oxygen concentration may lead to drop of arterial oxygen tension, decrease of brain oxygenation, and exacerbate brain function impairment. Intravenous anesthesia and inhalation anesthesia is two commonly used technique for general anesthesia. Consequently, we carry out this study to identify whether different classes of anesthetics can affect postoperative cognitive function in old patient undergoing laser laryngeal surgery.
Read the detailed description
The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation
The primary measurement is the MMS scores. The secondary measurements are intraoperative desaturation score (multiplying Spo2 < 90% by time (seconds)), extubation time, orientation time, and time to discharge from the post-anaesthesia care unit (PACU).
A sample size of 35 was determined by using a power analysis based on the assumptions that the incidence of postoperative cognitive impairment in adult after otorhinolaryngological surgery would be as high as 50 %, b) a 70% reduction (from 50% to 15%) would be of clinical significance, and c) α= 0.05, β= 0.2.
The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.
The outcome of interest is cognitive decline. A Generalized estimating equation (GEE) model with compound symmetry covariance structure was constructed to compare differences between two treatments with different time points as the repeated factors. As the effect of treatments may vary across different time points, an interaction between treatments and time was included in the model. Bonferroni-corrected post hoc test was conducted to adjust the observed significant level for multiple comparisons if the null hypothesis was rejected.
- Conditions
- Cognition Disorders in Old Age
- Being tested
- Propofol, Desflurane
- Keywords
- Laser Laryngeal Surgery, Desflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Propofol injection from AstraZeneca
In propofol/remifentanil group, propofol at a rate 75~150 µg/kg/min and remifentanil at 0.1-0.3 µg/kg/min are maintained throughout surgery.
DesfluraneDrug
Also called Suprane from Baxter
In desflurane/remifentanil group, desflurane at end tidal concentration at 0.7~1.0 minimum alveolar concentration (MAC) and remifentanil 0.1-0.3 ug/kg/min are used.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Experimental | Propofol/remifentanil-based general anesthesia. Receives: Drug: Propofol |
| desflurane group | Experimental | Desflurane/remifentanil-based general anesthesia. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Measured: Change of MMS score between two time points (the day before surgery and 30min postoperatively
Secondary outcomes (3)
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Measured: Change of MMS score between two time points (the day before surgery and 1h postoperatively
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Measured: Change of MMS score between two time points (the day before surgery and 3h postoperatively
Change of Mini-Mental State (MMS) test score
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
Measured: Change of MMS score between two time points (the day before surgery and 24h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start15 Aug 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognition Disorders in Old AgeStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Shen, Eye & ENT Hospital of Fudan University
- Investigators
- Xia Shen, M.D., Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194074
- Sponsor's protocol ID
- POCD-DesProp
- Acronym
- POCDLLS
- Status last verified
- Jul 2018
- First submitted
- 17 Jun 2017
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.
PubMed 21474666Larsen B, Seitz A, Larsen R. Recovery of cognitive function after remifentanil-propofol anesthesia: a comparison with desflurane and sevoflurane anesthesia. Anesth Analg. 2000 Jan;90(1):168-74. doi: 10.1097/00000539-200001000-00035.
PubMed 10624999Royse CF, Andrews DT, Newman SN, Stygall J, Williams Z, Pang J, Royse AG. The influence of propofol or desflurane on postoperative cognitive dysfunction in patients undergoing coronary artery bypass surgery. Anaesthesia. 2011 Jun;66(6):455-64. doi: 10.1111/j.1365-2044.2011.06704.x. Epub 2011 Apr 18.
PubMed 21501129Roy S, Smith LP. Surgical fires in laser laryngeal surgery: are we safe enough? Otolaryngol Head Neck Surg. 2015 Jan;152(1):67-72. doi: 10.1177/0194599814555853. Epub 2014 Oct 24.
PubMed 25344591
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Cognitive Function and Recovery in Elderly Patients After Laser Laryngeal Surgery: Desflurane-based vs Propofol-based Anesthesia
- ClinicalTrials.gov ID
- NCT03194074
- Acronym / sponsor ID
- POCDLLS / POCD-DesProp
- Conditions
- Cognition Disorders in Old Age
- Keywords
- Laser Laryngeal Surgery, Desflurane, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Jun 2017 (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 impairment is one of the most common complications in elderly surgical patients. Laser laryngeal surgery is a short procedure, but characterized by high risk of disastrous airway fire. So the recommended oxygen concentration is less than 30%. For elderly patients, because of preoperatively declined cardiovascular and lung function and cognitive function, there is a potential that intraoperative low oxygen concentration may lead to drop of arterial oxygen tension, decrease of brain oxygenation, and exacerbate brain function impairment. Intravenous anesthesia and inhalation anesthesia is two commonly used technique for general anesthesia. Consequently, we carry out this study to identify whether different classes of anesthetics can affect postoperative cognitive function in old patient undergoing laser laryngeal surgery.
Detailed description
The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation
The primary measurement is the MMS scores. The secondary measurements are intraoperative desaturation score (multiplying Spo2 < 90% by time (seconds)), extubation time, orientation time, and time to discharge from the post-anaesthesia care unit (PACU).
A sample size of 35 was determined by using a power analysis based on the assumptions that the incidence of postoperative cognitive impairment in adult after otorhinolaryngological surgery would be as high as 50 %, b) a 70% reduction (from 50% to 15%) would be of clinical significance, and c) α= 0.05, β= 0.2.
The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.
The outcome of interest is cognitive decline. A Generalized estimating equation (GEE) model with compound symmetry covariance structure was constructed to compare differences between two treatments with different time points as the repeated factors. As the effect of treatments may vary across different time points, an interaction between treatments and time was included in the model. Bonferroni-corrected post hoc test was conducted to adjust the observed significant level for multiple comparisons if the null hypothesis was rejected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Experimental | Drug: PropofolPropofol/remifentanil-based general anesthesia. |
| desflurane group | Experimental | Drug: DesfluraneDesflurane/remifentanil-based general anesthesia. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for laser laryngeal surgery under general anesthesia with either Propofol or desflurane based technique.
Key exclusion criteria (1 listed)
- Patients with cardiac, pulmonary, hepatic, or renal dysfunction, epilepsy, or uncontrolled hypertension, or those taking medications that influence the central nervous system, are excluded from the study. Patients who show obvious alteration of mental status, or refuse to participate, are also excluded from the study.
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 |
|---|---|---|
| PropofolAlso: Propofol injection from AstraZenecaIn propofol/remifentanil group, propofol at a rate 75~150 µg/kg/min and remifentanil at 0.1-0.3 µg/kg/min are maintained throughout surgery. | Drug | propofol group |
| DesfluraneAlso: Suprane from BaxterIn desflurane/remifentanil group, desflurane at end tidal concentration at 0.7~1.0 minimum alveolar concentration (MAC) and remifentanil 0.1-0.3 ug/kg/min are used. | Drug | desflurane group |
Primary outcome
Change of Mini-Mental State (MMS) test score
Time frame: Change of MMS score between two time points (the day before surgery and 30min postoperatively
Change of 30-point questionnaire that is used to measure cognitive impairment before and after surgery
3 secondary outcomes
Change of Mini-Mental State (MMS) test score
Time frame: Change of MMS score between two time points (the day before surgery and 1h postoperatively
Change of Mini-Mental State (MMS) test score
Time frame: Change of MMS score between two time points (the day before surgery and 3h postoperatively
Change of Mini-Mental State (MMS) test score
Time frame: Change of MMS score between two time points (the day before surgery and 24h postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Background: PubMed 21474666Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7.
- Background: PubMed 10624999Larsen B, Seitz A, Larsen R. Recovery of cognitive function after remifentanil-propofol anesthesia: a comparison with desflurane and sevoflurane anesthesia. Anesth Analg. 2000 Jan;90(1):168-74. doi: 10.1097/00000539-200001000-00035.
- Background: PubMed 21501129Royse CF, Andrews DT, Newman SN, Stygall J, Williams Z, Pang J, Royse AG. The influence of propofol or desflurane on postoperative cognitive dysfunction in patients undergoing coronary artery bypass surgery. Anaesthesia. 2011 Jun;66(6):455-64. doi: 10.1111/j.1365-2044.2011.06704.x. Epub 2011 Apr 18.
- Background: PubMed 25344591Roy S, Smith LP. Surgical fires in laser laryngeal surgery: are we safe enough? Otolaryngol Head Neck Surg. 2015 Jan;152(1):67-72. doi: 10.1177/0194599814555853. Epub 2014 Oct 24.
- 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.
Xia Shen, M.D. principal investigator
Eye & ENT Hospital of Fudan University
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 Propofol and Desflurane in people with Cognition Disorders in Old Age, run by Eye & ENT Hospital of Fudan University 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 1 inclusion and 1 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 27 Jul 2018. 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. 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?
Contact Xia Shen, M.D. (8613611874118, zlsx@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Mini-Mental State (MMS) test score (time frame: Change of MMS score between two time points (the day before surgery and 30min postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03194074, which also lists 4 linked publications.
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 27 Jul 2018.