Intracranial TumorsNCT07805876
The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications
A study testing Ciprofo and Propofol in people with Intracranial Tumors, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postoperative delirium and postoperative ischemic stroke are common neurological complications in clinical practice. The incidence of these complications is further increased in patients undergoing neurosurgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Tumors
- What is being tested?
- Ciprofo and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2026to 31 Mar 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status I to III
- Patients scheduled for elective surgery for supratentorial intracranial tumors, with imaging findings meeting the following criteria:
- Displacement of midline structures (e.g., septum pellucidum, pineal gland, falx cerebri) by ≥5 mm due to the tumor's mass effect or peritumoral edema;
- . Compression or deformation of the ventricular system, particularly symmetric or asymmetric narrowing of the lateral ventricles and the third ventricle;
- . Shallowed or absent sulci, fissures, and cisterns, with the subarachnoid spaces compressed due to brain tissue swelling or mass effect
- Obtain written informed consent
Who cannot join
- History of transient ischemic attack or cerebral infarction within the past one year
- Patients with a history of psychiatric or neurological disorders (such as depression, schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) or those taking antipsychotic medications, antidepressants, glucocorticoids, as well as patients with alcohol abuse or illicit drug abuse
- Personal history of intellectual disability or a preoperative Mini-Mental State Examination score indicating impaired cognitive function (defined as follows based on the subject's educational level: illiterate < 17 points, elementary school education < 20 points, middle school education or higher < 24 points), language disorders, or inability to cooperate with the researcher during psychiatric assessment
- Uncontrolled hypertension, diabetes, or a history of hematological disorders
- Preoperative severe hepatic or renal insufficiency
- Contraindications to the use of cyclopropane and propofol
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
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications in Patients With Increased Intracranial Pressure Caused by Intracranial Tumors: a Randomized Controlled Trial
Postoperative delirium and postoperative ischemic stroke are common neurological complications in clinical practice. The incidence of these complications is further increased in patients undergoing neurosurgical procedures. Intraoperative hypotension and burst suppression are high-risk factors for postoperative delirium and ischemic stroke. Ciprofol, as a new intravenous general anesthetic, can significantly reduce the occurrence of hypotension and decrease burst suppression compared with propofol. However, no study has demonstrated that the application of ciprofol in neurosurgical patients can improve patient prognosis. Therefore, the purpose of this study is to explore the impact of using ciprofol or propofol in anesthesia induction and maintenance on postoperative neurological complications in patients with high intracranial pressure.
- Conditions
- Intracranial Tumors
- Being tested
- Ciprofo, Propofol
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofoDrug
During the induction of anaesthesia, a single bolus injection of 0.4 mg/kg ciprofol will be administered for rapid-sequence induction. During anaesthesia maintenance, ciprofol will be continuously infused at a dose of 0.4 - 2.4 mg/kg/h.
PropofolDrug
During the induction of anaesthesia, a single bolus injection of 2 mg/kg propofol will be administered for rapid-sequence induction. During anaesthesia maintenance, propofol will be continuously infused at a dose of 2 - 5 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group | Experimental | Participants will undergo anaesthesia induction with ciprofol, followed by total intravenous anaesthesia with ciprofol for maintenance. Receives: Drug: Ciprofo |
| Propofol group | Other | Participants will undergo anaesthesia induction with propofol, followed by total intravenous anaesthesia with propofol for maintenance. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.
Measured: 1 day before surgery to the 5th 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 posted8 Sep 2026
- Study start7 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial TumorsStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming Peng, MD,Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805876
- Sponsor's protocol ID
- 20260831
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications in Patients With Increased Intracranial Pressure Caused by Intracranial Tumors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07805876
- Acronym / sponsor ID
- 20260831
- Conditions
- Intracranial Tumors
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 434 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 8 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.
Postoperative delirium and postoperative ischemic stroke are common neurological complications in clinical practice. The incidence of these complications is further increased in patients undergoing neurosurgical procedures. Intraoperative hypotension and burst suppression are high-risk factors for postoperative delirium and ischemic stroke. Ciprofol, as a new intravenous general anesthetic, can significantly reduce the occurrence of hypotension and decrease burst suppression compared with propofol. However, no study has demonstrated that the application of ciprofol in neurosurgical patients can improve patient prognosis. Therefore, the purpose of this study is to explore the impact of using ciprofol or propofol in anesthesia induction and maintenance on postoperative neurological complications in patients with high intracranial pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group | Experimental | Drug: CiprofoParticipants will undergo anaesthesia induction with ciprofol, followed by total intravenous anaesthesia with ciprofol for maintenance. |
| Propofol group | Other | Drug: PropofolParticipants will undergo anaesthesia induction with propofol, followed by total intravenous anaesthesia with propofol for maintenance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- American Society of Anesthesiologists physical status I to III
- Patients scheduled for elective surgery for supratentorial intracranial tumors, with imaging findings meeting the following criteria:
- Obtain written informed consent
Key exclusion criteria (6 listed)
- History of transient ischemic attack or cerebral infarction within the past one year
- Patients with a history of psychiatric or neurological disorders (such as depression, schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) or those taking antipsychotic medications, antidepressants, glucocorticoids, as well as patients with alcohol abuse or illicit drug abuse
- Personal history of intellectual disability or a preoperative Mini-Mental State Examination score indicating impaired cognitive function (defined as follows based on the subject's educational level: illiterate < 17 points, elementary school education < 20 points, middle school education or higher < 24 points), language disorders, or inability to cooperate with the researcher during psychiatric assessment
- Uncontrolled hypertension, diabetes, or a history of hematological disorders
- Preoperative severe hepatic or renal insufficiency
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 |
|---|---|---|
| CiprofoDuring the induction of anaesthesia, a single bolus injection of 0.4 mg/kg ciprofol will be administered for rapid-sequence induction. During anaesthesia maintenance, ciprofol will be continuously infused at a dose of 0.4 - 2.4 mg/kg/h. | Drug | Ciprofol group |
| PropofolDuring the induction of anaesthesia, a single bolus injection of 2 mg/kg propofol will be administered for rapid-sequence induction. During anaesthesia maintenance, propofol will be continuously infused at a dose of 2 - 5 mg/kg/h. | Drug | Propofol group |
Primary outcome
The incidence of postoperative delirium
Time frame: 1 day before surgery to the 5th day after surgery
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.
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 9 Sep 2026.
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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.
Yuming Peng, MD,Ph.D principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ciprofo and Propofol in people with Intracranial Tumors, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 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: opening soon, as of the sponsor's last update on 9 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 Yuming Peng, MD,Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (time frame: 1 day before surgery to the 5th day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.