Postoperative DeliriumPhase 4NCT06046638
Cyclopofol Versus Propofol for Postoperative Delirium in Elderly Patients Having Orthopedic Surgery
A Phase 4 study testing Cyclopofol and Propofol in people with Postoperative Delirium and Stroke, run by RenJi Hospital.
Trial summary
Postoperative delirium (POD) is common in elderly patients recovering from surgery and anesthesia. POD has adverse effects on early and long-term prognosis. The incidence of POD increases with age and patients with preoperative cognitive changes or coexisting diseases. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Postoperative Delirium, Stroke
- What is being tested?
- Cyclopofol and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 to 90 years old (including the critical value), male or female;
- Scheduled to undergo orthopaedic surgery under general anesthesia, including femoral surgery, hip surgery, lumbar spine surgery, and do not plan to enter the ICU after surgery;
- ASA II-III;
- Preoperative mild cognitive function changes (MMSE score 21-26);
- Multiple coexisting diseases (at least one or more), including history of stroke (at least 6 months before elective surgery), hypertension, diabetes, ischemic heart disease, chronic obstructive pulmonary disease, obstructive sleep apnea, chronic kidney disease, hypoalbuminemia, anemia, water electricity and acid-base disorders;
- The expected hospital stay is at least 2 days;
- Agree to participate and give written informed consent.
Who cannot join
- Patients with preoperative delirium (3D-CAM positive);
- Patients with severe cognitive impairment (MMSE score <15);
- Patients with history of psychological and nervous system diseases (such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc.) that interfere with the judgment of curative effect indicators disease factors;
- Patients with severe congestive heart failure (New York Heart Association, class IV) or severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV);
- The surgical site interferes with the placement of BIS electrodes;
- Mental or language barriers impede data collection; Other reasons (such as hearing impairment or visual impairment) could not complete the MMSE, MoCA scales.
About this study
Official title: Cyclopofol Versus Propofol for Postoperative Delirium in Elderly Patients Having Orthopedic Surgery: A Single-center Randomised Exploratory Trial
Postoperative delirium (POD) is common in elderly patients recovering from surgery and anesthesia. POD has adverse effects on early and long-term prognosis. The incidence of POD increases with age and patients with preoperative cognitive changes or coexisting diseases.
The bispectral index (BIS) is an electroencephalographic measurement commonly used to monitor the depth of anesthesia. Low intraoperative BIS value (BIS<40) and prolonged duration of low BIS value maybe risk factors of POD. A small sub-study of BALANCED Anaesthesia Study demonstrated a protective effect of targeting a BIS of 50 to reduce POD compared with a BIS of 35. The stability of BIS during general anesthesia may affect the risk of POD in elderly patients. Therefore, it is very important to maintain a stable BIS value as much as possible during general anesthesia surgery, and a general anesthetic with good BIS stability is even more needed in clinical practice.
Cyclopofol is a new type of anesthetic/sedative that reportedly provides good efficacy and safety. Cyclopofol has a more stable effect on BIS, so whether the use of cyclopofol in elderly patients undergoing orthopedic surgery can reduce the occurrence of POD, improve prognosis, and exert a brain protective effect will be of great importance and clinical research value.
Read the detailed description
Postoperative delirium (POD) is common in elderly patients after surgery and anesthesia which occurs within 24 to 72 hours after surgery. POD has adverse effects on early and long-term prognosis, including increased risk of postoperative complications, perioperative mortality, prolonged hospital stay, and increased incidence of long-term cognitive impairment and long-term mortality. The underlying mechanisms of POD are not fully understood, various hypotheses exist including neuroinflammation, neurotransmitter interference, and disturbances in communication throughout the brain network. The incidence of POD varies greatly among patients with different surgeries. POD can be as high as 50% in patients over 60 years of age after cardiac surgery, 8% to 54% after gastrointestinal surgery, and 5% to 14% after joint replacement surgery. In general, the incidence of POD in minor surgery is low, and the incidence of POD in major surgery is higher. The incidence of POD is significantly increased in patients over 65 years of age, and increases with age. POD also increases in patients with preoperative cognitive changes or coexisting diseases. With an increasing number of elderly patients undergoing surgery and anesthesia, POD has become a major global health challenge requiring urgent attention.
The bispectral index (BIS) is an electroencephalographic measurement commonly used to monitor the depth of anesthesia. BIS monitoring allows anesthesiologists to adjust medications according to the situation, allowing patients to recover from anesthesia more quickly and reduce the incidence of intraoperative awareness. Recent studies have shown that low intraoperative BIS value (BIS<40) and prolonged duration of low BIS value are both risk factors of POD which can predict the occurrence of POD. Low cerebral oxygen saturation is also risk factor of POD. The stability of BIS during general anesthesia may affect the risk of POD in elderly patients. Therefore, it is very important to maintain a stable BIS value as much as possible during general anesthesia surgery, and a general anesthetic with good BIS stability is even more needed in clinical practice.
Propofol is the most commonly used general anesthesia sedative during general anesthesia surgery. However, adverse events such as BIS burst suppression during induction and maintenance of general anesthesia are frequently associated with propofol. BIS stability is closely related to the incidence, prognosis and functional recovery of POD in elderly patients. Cyclopofol (a new type of anesthetic/sedative) has been approved by the Chinese Food and Drug Administration for "sedation and anesthesia during non-tracheal intubation surgery/operation", "general anesthesia induction and maintenance" and "intensive care during intensive care". "Sedation and anesthesia for outpatient surgery in gynecology" is still under consideration. Cyclopofol provides general anesthesia/sedation with good efficacy and safety.
Cyclopofol has the effect of stabilizing BIS. According to the results of the Phase III clinical study on induction and maintenance of general anesthesia with cyclopofol (study number HSK3486-302), the average range of BIS in the cyclopofol group was significantly smaller than that in the propofol group, and the lowest or highest BIS value between 30 and 60 was higher than that in the propofol group, and the highest BIS value >60 was significantly lower than that in the propofol group, indicating that the change of BIS after cyclopofol administration was more stable than that of propofol group. Consequently, cyclopofol may reduce POD, improve prognosis, and provide brain protection.
- Conditions
- Postoperative Delirium, Stroke
- Being tested
- Cyclopofol, Propofol
- Keywords
- Cyclopofol, Propofol, Postoperative Delirium, Stroke, Orthopedic Surgery, Elderly Patients
- Medical subject headings
- Emergence Delirium, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclopofolDrug
Also called Haisco Pharmaceutical Group Co., Ltd
Induction of anesthesia followed by continuous infusion through out surgery. The anesthetic drug regimen will be adjusted according to the changes of blood pressure.
PropofolDrug
Also called Fresenius Kabi Austria GmbH
Induction of anesthesia followed by continuous infusion through out surgery. The anesthetic drug regimen will be adjusted according to the changes of blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Cyclopofol | Experimental | For patients in the cyclopofol group, cyclopofol will be given as induction of anesthesia (0.4 mg/kg) followed by a continuous infusion (0.8 mg/kg/h) until the end of surgery. Receives: Drug: Cyclopofol |
| Propofol | Active comparator | For patients in the propofol group, propofol will be given as induction of anesthesia (2 mg/kg) followed by a continuous infusion (5 mg/kg/h) until the end of surgery. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POD within 3 days after surgery (3D-CAM)
Incidence of POD will be assessed at baseline and once daily within 3 days after surgery (3D-CAM) by anesthesiologist(s).
Measured: 72 hours post surgery
Secondary outcomes (17)
Incidence of POD within 3 days after surgery (CAM-ICU)
Incidence of POD will be assessed once daily within 3 days after surgery (CAM-ICU) by anesthesiologist(s).
Measured: 72 hours post surgery
Low BIS level
Low BIS (BIS<40)
Measured: During surgery
Duration of low BIS level
Duration of low BIS
Measured: During surgery
Cerebral oxygen metabolism index
Internal jugular vein oxygen saturation (SjvO2)
Measured: During surgery
Cerebral oxygen saturation
Cerebral oxygen saturation monitoring
Measured: During surgery
Biochemical indicators of brain injury
NSE level
Measured: Before induction of anesthesia; At the end of the surgery; 24 hours post surgery
Serum inflammatory factors
Levels of CRP, TNF-α, IL-6 and IL-1 in peripheral blood
Measured: Before induction of anesthesia; At the end of the surgery; 24 hours post surgery
Postoperative consciousness recovery time
Record the time when patients recover from anesthesia
Measured: During PACU, an average of 1 hour
Total duration of hypotension
MBP<65 mmHg or MBP decrease≥20% of baseline per hour during surgery, treatment measures (including vasopressors, inotropes, fluid use and dosage)
Measured: During surgery
Length of hospital stay
Record the time when patients discharge from hospital
Measured: Through hospitalization completion, an average of 1 week
MMSE Cognitive ability assessment
MMSE score (the minimum value is 0 and the maximum value is 30, and higher scores mean a better outcome) at discharge and on the 30th postoperative day
Measured: Through hospitalization completion, an average of 1 week; 30 days post surgery
AMTS Cognitive ability assessment
AMTS score (the minimum value is 0 and the maximum value is 10, and higher scores mean a better outcome) at discharge and on the 30th postoperative day
Measured: Through hospitalization completion, an average of 1 week; 30 days post surgery
MoCA Cognitive ability assessment
MoCA score (the minimum value is 0 and the maximum value is 30, and higher scores mean a better outcome) at discharge and on the 30th postoperative day
Measured: Through hospitalization completion, an average of 1 week; 30 days post surgery
ADL Cognitive ability assessment
ADL score (the minimum value is 0 and the maximum value is 100, and higher scores mean a better outcome) at discharge and on the 30th postoperative day
Measured: Through hospitalization completion, an average of 1 week; 30 days post surgery
mRS Cognitive ability assessment
mRS score (the minimum value is 0 and the maximum value is 5, and lower scores mean a better outcome) at discharge and on the 30th postoperative day
Measured: Through hospitalization completion, an average of 1 week; 30 days post surgery
Mortality within 30 days after surgery
Record whether patients die within 30 days after surgery
Measured: 30 days post surgery
Unplanned admission to the ICU within 30 days after surgery
Only relevant to the operation, including the frequency, duration, and drug use
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haisco Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046638
- Sponsor's protocol ID
- LY2022-087-B
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclopofol Versus Propofol for Postoperative Delirium in Elderly Patients Having Orthopedic Surgery: A Single-center Randomised Exploratory Trial
- ClinicalTrials.gov ID
- NCT06046638
- Acronym / sponsor ID
- LY2022-087-B
- Conditions
- Postoperative Delirium, Stroke
- Keywords
- Cyclopofol, Propofol, Postoperative Delirium, Stroke, Orthopedic Surgery, Elderly Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Haisco Pharmaceutical Group Co., Ltd.
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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 delirium (POD) is common in elderly patients recovering from surgery and anesthesia. POD has adverse effects on early and long-term prognosis. The incidence of POD increases with age and patients with preoperative cognitive changes or coexisting diseases.
The bispectral index (BIS) is an electroencephalographic measurement commonly used to monitor the depth of anesthesia. Low intraoperative BIS value (BIS<40) and prolonged duration of low BIS value maybe risk factors of POD. A small sub-study of BALANCED Anaesthesia Study demonstrated a protective effect of targeting a BIS of 50 to reduce POD compared with a BIS of 35. The stability of BIS during general anesthesia may affect the risk of POD in elderly patients. Therefore, it is very important to maintain a stable BIS value as much as possible during general anesthesia surgery, and a general anesthetic with good BIS stability is even more needed in clinical practice.
Cyclopofol is a new type of anesthetic/sedative that reportedly provides good efficacy and safety. Cyclopofol has a more stable effect on BIS, so whether the use of cyclopofol in elderly patients undergoing orthopedic surgery can reduce the occurrence of POD, improve prognosis, and exert a brain protective effect will be of great importance and clinical research value.
Detailed description
Postoperative delirium (POD) is common in elderly patients after surgery and anesthesia which occurs within 24 to 72 hours after surgery. POD has adverse effects on early and long-term prognosis, including increased risk of postoperative complications, perioperative mortality, prolonged hospital stay, and increased incidence of long-term cognitive impairment and long-term mortality. The underlying mechanisms of POD are not fully understood, various hypotheses exist including neuroinflammation, neurotransmitter interference, and disturbances in communication throughout the brain network. The incidence of POD varies greatly among patients with different surgeries. POD can be as high as 50% in patients over 60 years of age after cardiac surgery, 8% to 54% after gastrointestinal surgery, and 5% to 14% after joint replacement surgery. In general, the incidence of POD in minor surgery is low, and the incidence of POD in major surgery is higher. The incidence of POD is significantly increased in patients over 65 years of age, and increases with age. POD also increases in patients with preoperative cognitive changes or coexisting diseases. With an increasing number of elderly patients undergoing surgery and anesthesia, POD has become a major global health challenge requiring urgent attention.
The bispectral index (BIS) is an electroencephalographic measurement commonly used to monitor the depth of anesthesia. BIS monitoring allows anesthesiologists to adjust medications according to the situation, allowing patients to recover from anesthesia more quickly and reduce the incidence of intraoperative awareness. Recent studies have shown that low intraoperative BIS value (BIS<40) and prolonged duration of low BIS value are both risk factors of POD which can predict the occurrence of POD. Low cerebral oxygen saturation is also risk factor of POD. The stability of BIS during general anesthesia may affect the risk of POD in elderly patients. Therefore, it is very important to maintain a stable BIS value as much as possible during general anesthesia surgery, and a general anesthetic with good BIS stability is even more needed in clinical practice.
Propofol is the most commonly used general anesthesia sedative during general anesthesia surgery. However, adverse events such as BIS burst suppression during induction and maintenance of general anesthesia are frequently associated with propofol. BIS stability is closely related to the incidence, prognosis and functional recovery of POD in elderly patients. Cyclopofol (a new type of anesthetic/sedative) has been approved by the Chinese Food and Drug Administration for "sedation and anesthesia during non-tracheal intubation surgery/operation", "general anesthesia induction and maintenance" and "intensive care during intensive care". "Sedation and anesthesia for outpatient surgery in gynecology" is still under consideration. Cyclopofol provides general anesthesia/sedation with good efficacy and safety.
Cyclopofol has the effect of stabilizing BIS. According to the results of the Phase III clinical study on induction and maintenance of general anesthesia with cyclopofol (study number HSK3486-302), the average range of BIS in the cyclopofol group was significantly smaller than that in the propofol group, and the lowest or highest BIS value between 30 and 60 was higher than that in the propofol group, and the highest BIS value >60 was significantly lower than that in the propofol group, indicating that the change of BIS after cyclopofol administration was more stable than that of propofol group. Consequently, cyclopofol may reduce POD, improve prognosis, and provide brain protection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclopofol | Experimental | Drug: CyclopofolFor patients in the cyclopofol group, cyclopofol will be given as induction of anesthesia (0.4 mg/kg) followed by a continuous infusion (0.8 mg/kg/h) until the end of surgery. |
| Propofol | Active comparator | Drug: PropofolFor patients in the propofol group, propofol will be given as induction of anesthesia (2 mg/kg) followed by a continuous infusion (5 mg/kg/h) until the end of surgery. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65 to 90 years old (including the critical value), male or female;
- Scheduled to undergo orthopaedic surgery under general anesthesia, including femoral surgery, hip surgery, lumbar spine surgery, and do not plan to enter the ICU after surgery;
- ASA II-III;
- Preoperative mild cognitive function changes (MMSE score 21-26);
- Multiple coexisting diseases (at least one or more), including history of stroke (at least 6 months before elective surgery), hypertension, diabetes, ischemic heart disease, chronic obstructive pulmonary disease, obstructive sleep apnea, chronic kidney disease, hypoalbuminemia, anemia, water electricity and acid-base disorders;
Key exclusion criteria (6 listed)
- Patients with preoperative delirium (3D-CAM positive);
- Patients with severe cognitive impairment (MMSE score <15);
- Patients with history of psychological and nervous system diseases (such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc.) that interfere with the judgment of curative effect indicators disease factors;
- Patients with severe congestive heart failure (New York Heart Association, class IV) or severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV);
- The surgical site interferes with the placement of BIS electrodes;
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 |
|---|---|---|
| CyclopofolAlso: Haisco Pharmaceutical Group Co., LtdInduction of anesthesia followed by continuous infusion through out surgery. The anesthetic drug regimen will be adjusted according to the changes of blood pressure. | Drug | Cyclopofol |
| PropofolAlso: Fresenius Kabi Austria GmbHInduction of anesthesia followed by continuous infusion through out surgery. The anesthetic drug regimen will be adjusted according to the changes of blood pressure. | Drug | Propofol |
Primary outcome
Incidence of POD within 3 days after surgery (3D-CAM)
Time frame: 72 hours post surgery
Incidence of POD will be assessed at baseline and once daily within 3 days after surgery (3D-CAM) by anesthesiologist(s).
17 secondary outcomes
Incidence of POD within 3 days after surgery (CAM-ICU)
Time frame: 72 hours post surgery
Low BIS level
Time frame: During surgery
Duration of low BIS level
Time frame: During surgery
Cerebral oxygen metabolism index
Time frame: During surgery
Cerebral oxygen saturation
Time frame: During surgery
Biochemical indicators of brain injury
Time frame: Before induction of anesthesia; At the end of the surgery; 24 hours post surgery
Serum inflammatory factors
Time frame: Before induction of anesthesia; At the end of the surgery; 24 hours post surgery
Postoperative consciousness recovery time
Time frame: During PACU, an average of 1 hour
Total duration of hypotension
Time frame: During surgery
Length of hospital stay
Time frame: Through hospitalization completion, an average of 1 week
MMSE Cognitive ability assessment
Time frame: Through hospitalization completion, an average of 1 week; 30 days post surgery
AMTS Cognitive ability assessment
Time frame: Through hospitalization completion, an average of 1 week; 30 days post surgery
MoCA Cognitive ability assessment
Time frame: Through hospitalization completion, an average of 1 week; 30 days post surgery
ADL Cognitive ability assessment
Time frame: Through hospitalization completion, an average of 1 week; 30 days post surgery
mRS Cognitive ability assessment
Time frame: Through hospitalization completion, an average of 1 week; 30 days post surgery
Mortality within 30 days after surgery
Time frame: 30 days post surgery
Unplanned admission to the ICU within 30 days after surgery
Time frame: 30 days post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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 4 study testing Cyclopofol and Propofol in people with Postoperative Delirium and Stroke, run by RenJi Hospital.
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 7 inclusion and 6 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 21 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. 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?
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?
Incidence of POD within 3 days after surgery (3D-CAM) (time frame: 72 hours post 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 21 Sep 2023.