Brain NeoplasmsNCT07799623
Ciprofol, Propofol and Sevoflurane for Postoperative Delirium in Elderly Brain Tumor Patients
A study testing Ciprofol, Propofol and Sevoflurane in people with Brain Neoplasms and Delirium - Postoperative, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study will compare three anesthesia medicines used to put people into a deep sleep during surgery: ciprofol, propofol, and sevoflurane. All three are commonly used for general anesthesia, but they work in different ways. Ciprofol and propofol are given through a vein. Sevoflurane is breathed in as a gas. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Brain Neoplasms, Delirium - Postoperative
- What is being tested?
- Ciprofol, Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 3 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 65 to 90 years, either sex.
- Scheduled to undergo elective brain tumor resection under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Expected operative time ≥ 2 hours and anticipated postoperative hospital stay > 48 hours.
- Able to communicate in Chinese and complete cognitive assessments.
- Preoperative cognitive function intact: Telephone Montreal Cognitive Assessment (T-MoCA) score ≥ 18 and Confusion Assessment Method (CAM) negative.
- No use of analgesic or sedative medications on the day before surgery.
- Able to provide informed consent and willing to comply with postoperative follow-up through 180 days.
Who cannot join
- Preoperative use of medications that may affect postoperative cognition (e.g., long-term benzodiazepines, antidepressants, antipsychotics, or chronic sedative-hypnotic use that cannot be paused).
- Preoperative delirium, dementia, diagnosed severe psychiatric disorder, or existing central nervous system disease.
- History of alcohol addiction or drug abuse; suspected or confirmed long-term use of narcotic analgesics or sedatives.
- Severe visual, auditory, or speech impairment that precludes communication and cognitive testing.
- Severe cardiopulmonary disease: forced expiratory volume in 1 second (FEV1) or vital capacity < 50% of predicted; New York Heart Association (NYHA) functional class III-IV; severe hepatic or renal insufficiency (creatinine > 176 μmol/L, blood urea nitrogen > 7.1 mmol/L, albumin < 30 g/L, Child-Pugh class C, or preoperative dialysis).
- Known difficult airway, malignant hyperthermia susceptibility, or other contraindication to general anesthesia.
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- Hypersensitivity or known allergy to ciprofol, propofol, sevoflurane, or other study-related agents.
- Severe uncontrolled infection or endocrine disorder.
- Concurrent participation in another clinical trial.
- Judged unsuitable for enrollment by the attending surgeon, anesthesiologist, or principal investigator for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tingting Wang, Ph.D., +86-13667265360, Wangtt201307@163.com
About this study
This study will compare three anesthesia medicines used to put people into a deep sleep during surgery: ciprofol, propofol, and sevoflurane. All three are commonly used for general anesthesia, but they work in different ways. Ciprofol and propofol are given through a vein. Sevoflurane is breathed in as a gas. After brain tumor surgery, some older adults may develop sudden confusion and memory problems called delirium. Researchers want to learn which of these three medicines is best at preventing delirium and protecting brain function in older adults undergoing brain tumor surgery.
About 381 participants aged 65 to 90 will take part. Participants will be randomly assigned to one of three groups. One group will receive ciprofol. Another group will receive propofol. The third group will receive sevoflurane. All participants will receive standard care during and after brain tumor removal.
Read more
The main goal is to compare how many participants develop delirium within 7 days after surgery. Researchers will also look at how long delirium lasts, how severe it is, thinking and memory skills at 7, 30, 90, and 180 days after surgery, quality of recovery, blood pressure and heart rate during surgery, and treatment safety.
Blood tests will be used to measure markers of body stress, inflammation, and nerve cell injury before surgery, 3 hours after surgery, and 1 day after surgery. Researchers will also test thinking and memory with simple questions twice a day for 7 days after surgery. Later follow-up will be done by phone at 30, 90, and 180 days after surgery.
This study is designed to explore which anesthesia medicine is safest and best at protecting the brain after surgery in older adults with brain tumors. The results may help doctors choose the best anesthesia for this group of patients in the future.
- Conditions
- Brain Neoplasms, Delirium - Postoperative
- Being tested
- Ciprofol, Propofol, Sevoflurane
- Keywords
- Ciprofol, Propofol, Sevoflurane, Postoperative Delirium, Brain Neoplasms, General Anesthesia, Aged, Cognitive Function
- Medical subject headings
- Brain Neoplasms, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Ciprofol injectable emulsion (20 mL: 50 mg) administered intravenously for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 0.3-0.4 mg/kg by slow intravenous injection over ≥30 seconds. Maintenance: continuous intravenous infusion at 0.4-2.4 mg/kg/h via infusion pump, beginning after induction and continuing until the end of surgery. Dose adjustments are made based on patient response and hemodynamic monitoring. Total duration depends on operative time.
PropofolDrug
Propofol injectable emulsion administered intravenously for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 1.5-2.0 mg/kg by slow intravenous injection over ≥30 seconds. Maintenance: continuous intravenous infusion at 4-12 mg/kg/h via infusion pump, beginning after induction and continuing until the end of surgery. Dose adjustments are made based on patient response and hemodynamic monitoring. Total duration depends on operative time.
SevofluraneDrug
Sevoflurane inhalation solution (volatile liquid) administered via inhalation through a calibrated vaporizer for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 7-8% inhaled concentration with oxygen flow 2-4 L/min until loss of consciousness. Maintenance: inhaled concentration adjusted to 1.0-3.0% and titrated to effect; concentration is gradually reduced beginning 30 minutes before the anticipated end of surgery and discontinued at the end of the procedure. Total duration depends on operative time.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol Group | Experimental | Participants will receive ciprofol for general anesthesia induction (0.3-0.4 mg/kg intravenous injection) and maintenance (0.4-2.4 mg/kg/h continuous intravenous infusion) during elective brain tumor resection. Receives: Drug: Ciprofol |
| Propofol Group | Active comparator | Participants will receive propofol for general anesthesia induction (1.5-2.0 mg/kg intravenous injection) and maintenance (4-12 mg/kg/h continuous intravenous infusion) during elective brain tumor resection. Receives: Drug: Propofol |
| Sevoflurane Group | Active comparator | Participants will receive sevoflurane for general anesthesia induction (7-8% inhaled) and maintenance (1.0-3.0% inhaled) during elective brain tumor resection. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Delirium Within 7 Days After Surgery as Assessed by the Confusion Assessment Method (CAM)
Delirium is diagnosed using the Confusion Assessment Method (CAM). A positive CAM assessment requires the simultaneous presence of Feature 1 (acute onset and fluctuating course) and Feature 2 (inattention), plus either Feature 3 (disorganized thinking) or Feature 4 (altered level of consciousness). The outcome is reported as the proportion of participants with at least one positive CAM assessment during the 7-day postoperative period.
Measured: Postoperative 2 hours, 6-12 hours, and twice daily (08:00-10:00 and 18:00-20:00) from postoperative Day 1 through Day 7
Secondary outcomes (18)
Duration of Postoperative Delirium in Days During the First 7 Days After Surgery
Duration is defined as the time interval from the first positive CAM diagnosis of delirium to the first assessment showing no delirium symptoms (CAM negative) for a continuous period of at least 24 hours. Recorded in days. If delirium persists beyond 7 days, the maximum recorded duration is 7 days.
Measured: Postoperative Day 1 through Day 7
Mean Daily CAM-Severity (CAM-S) Score During the First 7 Days After Surgery
The CAM-Severity scale quantifies delirium severity based on CAM features. The 4-item version ranges from 0 to 7 points; the 10-item version ranges from 0 to 19 points. Higher scores indicate more severe delirium. The mean daily score is calculated by averaging all CAM-S scores obtained during each calendar day.
Measured: Postoperative Day 1 through Day 7 (twice daily assessments)
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 7 Days After Surgery
The Telephone Montreal Cognitive Assessment (T-MoCA) evaluates cognitive function including attention, memory, language, and orientation. Total scores range from 0 to 22 points, with higher scores indicating better cognitive function. A score of 18 or above indicates normal cognitive function. Change from baseline is calculated as the post-treatment score minus the baseline score; a positive change indicates improvement and a negative change indicates decline.
Measured: Baseline (1 day before surgery) and postoperative Day 7
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 30 Days After Surgery
The Telephone Montreal Cognitive Assessment (T-MoCA) evaluates cognitive function including attention, memory, language, and orientation. Total scores range from 0 to 22 points, with higher scores indicating better cognitive function. Change from baseline is calculated as the post-treatment score minus the baseline score; a positive change indicates improvement and a negative change indicates decline.
Measured: Baseline (1 day before surgery) and postoperative Day 30
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 90 Days After Surgery
The Telephone Montreal Cognitive Assessment (T-MoCA) evaluates cognitive function including attention, memory, language, and orientation. Total scores range from 0 to 22 points, with higher scores indicating better cognitive function. Change from baseline is calculated as the post-treatment score minus the baseline score; a positive change indicates improvement and a negative change indicates decline.
Measured: Baseline (1 day before surgery) and postoperative Day 90
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 180 Days After Surgery
The Telephone Montreal Cognitive Assessment (T-MoCA) evaluates cognitive function including attention, memory, language, and orientation. Total scores range from 0 to 22 points, with higher scores indicating better cognitive function. Change from baseline is calculated as the post-treatment score minus the baseline score; a positive change indicates improvement and a negative change indicates decline.
Measured: Baseline (1 day before surgery) and postoperative Day 180
Change in Quality of Recovery From Baseline as Assessed by QoR-15 at 1 Day After Surgery
The 15-item Quality of Recovery scale (QoR-15) assesses physical and psychological recovery after surgery. Each item is scored from 0 (never able to achieve the state) to 10 (always able to achieve the state), with a total score range of 0 to 150. Higher scores indicate better quality of recovery. Change from baseline is calculated as the post-treatment score minus the baseline score.
Measured: Baseline (1 day before surgery) and postoperative Day 1
Change in Quality of Recovery From Baseline as Assessed by QoR-15 at 3 Days After Surgery
The 15-item Quality of Recovery scale (QoR-15) assesses physical and psychological recovery after surgery. Each item is scored from 0 (never able to achieve the state) to 10 (always able to achieve the state), with a total score range of 0 to 150. Higher scores indicate better quality of recovery. Change from baseline is calculated as the post-treatment score minus the baseline score.
Measured: Baseline (1 day before surgery) and postoperative Day 3
Maximum Richmond Agitation-Sedation Scale (RASS) Score During Post-Anesthesia Care Unit (PACU) Stay
The Richmond Agitation-Sedation Scale (RASS) assesses the level of consciousness and agitation in the post-anesthesia care unit (PACU). Scores range from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm. Higher positive scores indicate greater agitation; more negative scores indicate deeper sedation. The maximum RASS score is defined as the highest score observed across all serial assessments from admission to the PACU until discharge. A higher maximum score indicates more severe postoperative agitation.
Measured: From PACU admission to PACU discharge, with assessments at 2, 30, 60, 90, 120, 150, and 180 minutes after extubation
Time to Loss of Consciousness Following Start of Anesthesia Induction
Time from the start of anesthetic drug administration to loss of eyelash reflex and unresponsiveness to verbal command, indicating successful anesthesia induction.
Measured: During anesthesia induction (measured in minutes)
Time to Emergence From Anesthesia After Cessation of Anesthetic Agents
Time from cessation of all anesthetic agents to eye opening in response to verbal command or spontaneous movement, indicating recovery of consciousness.
Measured: From end of surgery to emergence in the PACU (measured in minutes)
Time to Tracheal Extubation After Cessation of Anesthetic Agents
Time from cessation of all anesthetic agents to removal of the endotracheal tube after the return of adequate spontaneous breathing, airway reflexes, and consciousness.
Measured: From end of surgery to extubation in the PACU (measured in minutes)
Length of Stay in the Post-Anesthesia Care Unit (PACU)
Time from admission to the post-anesthesia care unit (PACU) to meeting discharge criteria (Steward recovery score ≥ 4) and transfer to the ward.
Measured: From PACU admission to PACU discharge (measured in minutes)
Change in Mean Arterial Pressure (MAP) From Baseline at 1 Minute After Induction, at Intubation, at Dural Incision, and at End of Surgery
Mean arterial pressure (MAP) is measured continuously via invasive arterial monitoring. Baseline MAP is obtained before anesthesia induction with the participant at rest. Change from baseline is calculated as the value at each intraoperative time point minus the baseline value. Negative values indicate a decrease from baseline; positive values indicate an increase.
Measured: Baseline (pre-induction) and intraoperative time points: 1 minute after induction, at intubation, at dural incision, and at end of surgery
Change in Heart Rate (HR) From Baseline at 1 Minute After Induction, at Intubation, at Dural Incision, and at End of Surgery
Heart rate (HR) is measured continuously via electrocardiogram monitoring. Baseline HR is obtained before anesthesia induction with the participant at rest. Change from baseline is calculated as the value at each intraoperative time point minus the baseline value. Negative values indicate a decrease from baseline; positive values indicate an increase.
Measured: Baseline (pre-induction) and intraoperative time points: 1 minute after induction, at intubation, at dural incision, and at end of surgery
Change in Serum Superoxide Dismutase (SOD) From Baseline at 3 Hours and 1 Day After Surgery
Serum SOD is measured by standardized laboratory assay as a marker of oxidative stress. Change from baseline is calculated as the postoperative concentration minus the preoperative concentration. Higher levels indicate greater antioxidant capacity.
Measured: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery
Change in Serum Interleukin-6 (IL-6) From Baseline at 3 Hours and 1 Day After Surgery
Serum IL-6 is measured by standardized laboratory assay as a marker of inflammation. Change from baseline is calculated as the postoperative concentration minus the preoperative concentration. Higher levels indicate greater inflammatory response.
Measured: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery
Change in Serum S100 Calcium-Binding Protein Beta (S100β) From Baseline at 3 Hours and 1 Day After Surgery
Serum S100β is measured by standardized laboratory assay as a marker of glial cell injury and blood-brain barrier disruption. Change from baseline is calculated as the postoperative concentration minus the preoperative concentration. Higher levels indicate greater central nervous system injury.
Measured: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion4 Jan 2027 (estimated)
- Study completion3 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 381 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799623
- Sponsor's protocol ID
- 1205-01
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available. All research data are managed under strict confidentiality policies of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and are designated for use exclusively in the statistical analysis and reporting of this study. Only aggregated, anonymized results will be disseminated through peer-reviewed publications, consistent with the informed consent and institutional data protection protocols.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciprofol, Propofol and Sevoflurane for Postoperative Delirium in Elderly Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT07799623
- Acronym / sponsor ID
- 1205-01
- Conditions
- Brain Neoplasms, Delirium - Postoperative
- Keywords
- Ciprofol, Propofol, Sevoflurane, Postoperative Delirium, Brain Neoplasms, General Anesthesia, Aged, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 3 Jul 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
This study will compare three anesthesia medicines used to put people into a deep sleep during surgery: ciprofol, propofol, and sevoflurane. All three are commonly used for general anesthesia, but they work in different ways. Ciprofol and propofol are given through a vein. Sevoflurane is breathed in as a gas. After brain tumor surgery, some older adults may develop sudden confusion and memory problems called delirium. Researchers want to learn which of these three medicines is best at preventing delirium and protecting brain function in older adults undergoing brain tumor surgery.
About 381 participants aged 65 to 90 will take part. Participants will be randomly assigned to one of three groups. One group will receive ciprofol. Another group will receive propofol. The third group will receive sevoflurane. All participants will receive standard care during and after brain tumor removal.
The main goal is to compare how many participants develop delirium within 7 days after surgery. Researchers will also look at how long delirium lasts, how severe it is, thinking and memory skills at 7, 30, 90, and 180 days after surgery, quality of recovery, blood pressure and heart rate during surgery, and treatment safety.
Blood tests will be used to measure markers of body stress, inflammation, and nerve cell injury before surgery, 3 hours after surgery, and 1 day after surgery. Researchers will also test thinking and memory with simple questions twice a day for 7 days after surgery. Later follow-up will be done by phone at 30, 90, and 180 days after surgery.
This study is designed to explore which anesthesia medicine is safest and best at protecting the brain after surgery in older adults with brain tumors. The results may help doctors choose the best anesthesia for this group of patients in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ciprofol Group | Experimental | Drug: CiprofolParticipants will receive ciprofol for general anesthesia induction (0.3-0.4 mg/kg intravenous injection) and maintenance (0.4-2.4 mg/kg/h continuous intravenous infusion) during elective brain tumor resection. |
| Propofol Group | Active comparator | Drug: PropofolParticipants will receive propofol for general anesthesia induction (1.5-2.0 mg/kg intravenous injection) and maintenance (4-12 mg/kg/h continuous intravenous infusion) during elective brain tumor resection. |
| Sevoflurane Group | Active comparator | Drug: SevofluraneParticipants will receive sevoflurane for general anesthesia induction (7-8% inhaled) and maintenance (1.0-3.0% inhaled) during elective brain tumor resection. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Aged 65 to 90 years, either sex.
- Scheduled to undergo elective brain tumor resection under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Expected operative time ≥ 2 hours and anticipated postoperative hospital stay > 48 hours.
- Able to communicate in Chinese and complete cognitive assessments.
Key exclusion criteria (10 listed)
- Preoperative use of medications that may affect postoperative cognition (e.g., long-term benzodiazepines, antidepressants, antipsychotics, or chronic sedative-hypnotic use that cannot be paused).
- Preoperative delirium, dementia, diagnosed severe psychiatric disorder, or existing central nervous system disease.
- History of alcohol addiction or drug abuse; suspected or confirmed long-term use of narcotic analgesics or sedatives.
- Severe visual, auditory, or speech impairment that precludes communication and cognitive testing.
- Severe cardiopulmonary disease: forced expiratory volume in 1 second (FEV1) or vital capacity < 50% of predicted; New York Heart Association (NYHA) functional class III-IV; severe hepatic or renal insufficiency (creatinine > 176 μmol/L, blood urea nitrogen > 7.1 mmol/L, albumin < 30 g/L, Child-Pugh class C, or preoperative dialysis).
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 |
|---|---|---|
| CiprofolCiprofol injectable emulsion (20 mL: 50 mg) administered intravenously for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 0.3-0.4 mg/kg by slow intravenous injection over ≥30 seconds. Maintenance: continuous intravenous infusion at 0.4-2.4 mg/kg/h via infusion pump, beginning after induction and continuing until the end of surgery. Dose adjustments are made based on patient response and hemodynamic monitoring. Total duration depends on operative time. | Drug | Ciprofol Group |
| PropofolPropofol injectable emulsion administered intravenously for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 1.5-2.0 mg/kg by slow intravenous injection over ≥30 seconds. Maintenance: continuous intravenous infusion at 4-12 mg/kg/h via infusion pump, beginning after induction and continuing until the end of surgery. Dose adjustments are made based on patient response and hemodynamic monitoring. Total duration depends on operative time. | Drug | Propofol Group |
| SevofluraneSevoflurane inhalation solution (volatile liquid) administered via inhalation through a calibrated vaporizer for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 7-8% inhaled concentration with oxygen flow 2-4 L/min until loss of consciousness. Maintenance: inhaled concentration adjusted to 1.0-3.0% and titrated to effect; concentration is gradually reduced beginning 30 minutes before the anticipated end of surgery and discontinued at the end of the procedure. Total duration depends on operative time. | Drug | Sevoflurane Group |
Primary outcome
Incidence of Postoperative Delirium Within 7 Days After Surgery as Assessed by the Confusion Assessment Method (CAM)
Time frame: Postoperative 2 hours, 6-12 hours, and twice daily (08:00-10:00 and 18:00-20:00) from postoperative Day 1 through Day 7
Delirium is diagnosed using the Confusion Assessment Method (CAM). A positive CAM assessment requires the simultaneous presence of Feature 1 (acute onset and fluctuating course) and Feature 2 (inattention), plus either Feature 3 (disorganized thinking) or Feature 4 (altered level of consciousness). The outcome is reported as the proportion of participants with at least one positive CAM assessment during the 7-day postoperative period.
18 secondary outcomes
Duration of Postoperative Delirium in Days During the First 7 Days After Surgery
Time frame: Postoperative Day 1 through Day 7
Mean Daily CAM-Severity (CAM-S) Score During the First 7 Days After Surgery
Time frame: Postoperative Day 1 through Day 7 (twice daily assessments)
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 7 Days After Surgery
Time frame: Baseline (1 day before surgery) and postoperative Day 7
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 30 Days After Surgery
Time frame: Baseline (1 day before surgery) and postoperative Day 30
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 90 Days After Surgery
Time frame: Baseline (1 day before surgery) and postoperative Day 90
Change in Cognitive Function From Baseline as Assessed by T-MoCA at 180 Days After Surgery
Time frame: Baseline (1 day before surgery) and postoperative Day 180
Change in Quality of Recovery From Baseline as Assessed by QoR-15 at 1 Day After Surgery
Time frame: Baseline (1 day before surgery) and postoperative Day 1
Change in Quality of Recovery From Baseline as Assessed by QoR-15 at 3 Days After Surgery
Time frame: Baseline (1 day before surgery) and postoperative Day 3
Maximum Richmond Agitation-Sedation Scale (RASS) Score During Post-Anesthesia Care Unit (PACU) Stay
Time frame: From PACU admission to PACU discharge, with assessments at 2, 30, 60, 90, 120, 150, and 180 minutes after extubation
Time to Loss of Consciousness Following Start of Anesthesia Induction
Time frame: During anesthesia induction (measured in minutes)
Time to Emergence From Anesthesia After Cessation of Anesthetic Agents
Time frame: From end of surgery to emergence in the PACU (measured in minutes)
Time to Tracheal Extubation After Cessation of Anesthetic Agents
Time frame: From end of surgery to extubation in the PACU (measured in minutes)
Length of Stay in the Post-Anesthesia Care Unit (PACU)
Time frame: From PACU admission to PACU discharge (measured in minutes)
Change in Mean Arterial Pressure (MAP) From Baseline at 1 Minute After Induction, at Intubation, at Dural Incision, and at End of Surgery
Time frame: Baseline (pre-induction) and intraoperative time points: 1 minute after induction, at intubation, at dural incision, and at end of surgery
Change in Heart Rate (HR) From Baseline at 1 Minute After Induction, at Intubation, at Dural Incision, and at End of Surgery
Time frame: Baseline (pre-induction) and intraoperative time points: 1 minute after induction, at intubation, at dural incision, and at end of surgery
Change in Serum Superoxide Dismutase (SOD) From Baseline at 3 Hours and 1 Day After Surgery
Time frame: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery
Change in Serum Interleukin-6 (IL-6) From Baseline at 3 Hours and 1 Day After Surgery
Time frame: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery
Change in Serum S100 Calcium-Binding Protein Beta (S100β) From Baseline at 3 Hours and 1 Day After Surgery
Time frame: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available. All research data are managed under strict confidentiality policies of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and are designated for use exclusively in the statistical analysis and reporting of this study. Only aggregated, anonymized results will be disseminated through peer-reviewed publications, consistent with the informed consent and institutional data protection protocols.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofol, Propofol and Sevoflurane in people with Brain Neoplasms and Delirium - Postoperative, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tingting Wang, Ph.D. (+86-13667265360, Wangtt201307@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Delirium Within 7 Days After Surgery as Assessed by the Confusion Assessment Method (CAM) (time frame: Postoperative 2 hours, 6-12 hours, and twice daily (08:00-10:00 and 18:00-20:00) from postoperative Day 1 through Day 7). 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 2 Sep 2026.