ClinicalTrials.gg
Not yet recruitingNCT07799623Updated Sep 2, 2026

Ciprofol, Propofol and Sevoflurane for Postoperative Delirium in Elderly Brain Tumor Patients

An interventional study of Ciprofol and Propofol in Brain Neoplasms and Delirium - Postoperative, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
381
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 179 studies in Brain Neoplasms with a site in China — 72 open to participants now, 84 under way, 6 of them phase 3. Brain Neoplasms · China.

Planned enrollment
14th of 142
381 · median 60
Started
2026
with 18 others
No phase
28 of 179
12 open now
Primary completion
2027-01
later than 45 of 83 live
Registered
176th of 179
by date

Among the 179 studies in Brain Neoplasms with a site in China, this one is the 14th largest by planned enrollment of the 142 interventional ones that give a count, is one of 19 that started in 2026, is one of 28 with no phase, reaches primary completion later than 45 of the 83 other live ones, and was the 176th registered.

Brain Neoplasms

2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.

Browse Brain Neoplasms studies →

Open to participants now

72 of the 179 studies in Brain Neoplasms with a site in China are open now. Recruiting first, the newest first:

67 more — sign in →

All 72 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 424 Brain Neoplasms studies recruiting now, 285 (67%) set no upper age limit and 82 (19%) stop at 75 or younger; 80 take children under 18; 36 take healthy volunteers.

This study: 65 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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. 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.

03

Conditions studied

  • Brain Neoplasms
  • Delirium - Postoperative

Keywords

  • Ciprofol
  • Propofol
  • Sevoflurane
  • Postoperative Delirium
  • Brain Neoplasms
  • General Anesthesia
  • Aged
  • Cognitive Function
04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 65 to 90 years, either sex.
  2. Scheduled to undergo elective brain tumor resection under general anesthesia.
  3. (ASA) physical status I-III.
  4. Expected operative time ≥ 2 hours and anticipated postoperative hospital stay > 48 hours.
  5. Able to communicate in Chinese and complete cognitive assessments.
  6. Preoperative cognitive function intact: Telephone (T-MoCA) score ≥ 18 and Confusion Assessment Method (CAM) negative.
  7. No use of analgesic or sedative medications on the day before surgery.
  8. Able to provide and willing to comply with postoperative follow-up through 180 days.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Preoperative delirium, dementia, diagnosed severe psychiatric disorder, or existing central nervous system disease.
  3. History of alcohol addiction or drug abuse; suspected or confirmed long-term use of narcotic analgesics or sedatives.
  4. Severe visual, auditory, or speech impairment that precludes communication and cognitive testing.
  5. Severe cardiopulmonary disease: (FEV1) or vital capacity \< 50% of predicted; (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, class C, or preoperative dialysis).
  6. Known difficult airway, malignant hyperthermia susceptibility, or other to general anesthesia.
  7. or known allergy to ciprofol, propofol, sevoflurane, or other study-related agents.
  8. Severe uncontrolled infection or endocrine disorder.
  9. Concurrent participation in another clinical trial.
  10. Judged unsuitable for enrollment by the attending surgeon, anesthesiologist, or principal investigator for any other reason.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
381 participants (estimated)

Study arms

  • Experimental
    Ciprofol Group

    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.

    Drug: Ciprofol

  • Active comparator
    Propofol Group

    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.

    Drug: Propofol

  • Active comparator
    Sevoflurane Group

    Participants will receive sevoflurane for general anesthesia induction (7-8% inhaled) and maintenance (1.0-3.0% inhaled) during elective brain tumor resection.

    Drug: Sevoflurane

Interventions

  • 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.

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. 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.

    Time frame: Postoperative Day 1 through Day 7

  2. 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.

    Time frame: Postoperative Day 1 through Day 7 (twice daily assessments)

  3. 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.

    Time frame: Baseline (1 day before surgery) and postoperative Day 7

  4. 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.

    Time frame: Baseline (1 day before surgery) and postoperative Day 30

  5. 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.

    Time frame: Baseline (1 day before surgery) and postoperative Day 90

  6. 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.

    Time frame: Baseline (1 day before surgery) and postoperative Day 180

  7. 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.

    Time frame: Baseline (1 day before surgery) and postoperative Day 1

  8. 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.

    Time frame: Baseline (1 day before surgery) and postoperative Day 3

  9. 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.

    Time frame: From PACU admission to PACU discharge, with assessments at 2, 30, 60, 90, 120, 150, and 180 minutes after extubation

  10. 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.

    Time frame: During anesthesia induction (measured in minutes)

  11. 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.

    Time frame: From end of surgery to emergence in the PACU (measured in minutes)

  12. 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.

    Time frame: From end of surgery to extubation in the PACU (measured in minutes)

  13. 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.

    Time frame: From PACU admission to PACU discharge (measured in minutes)

  14. 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.

    Time frame: Baseline (pre-induction) and intraoperative time points: 1 minute after induction, at intubation, at dural incision, and at end of surgery

  15. 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.

    Time frame: Baseline (pre-induction) and intraoperative time points: 1 minute after induction, at intubation, at dural incision, and at end of surgery

  16. 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.

    Time frame: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery

  17. 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.

    Time frame: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery

  18. 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.

    Time frame: Baseline (1 day before surgery), 3 hours after surgery, and 1 day after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jan 2027, 3 months later.

Of 306 non-industry interventional studies with no phase under Brain Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 125. This study's planned 3 months is below that.

Counting every sponsor, half of 317 studies reached it within 64 months; a quarter within 35 and three quarters within 125.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2026
First posted
Sep 2, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Jan 4, 2027
CompletionEst.
Jul 3, 2027
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07799623
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jan 4, 2027 (estimated)
Completion
Jul 3, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Tingting Wang, Ph.D.
Contact
Wangtt201307@163.com
+86-13667265360

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ciprofol

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