Elderly PatientsPhase 4NCT06253078
Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients
A Phase 4 study testing Ciprofol dose 0.4mg/Kg, Ciprofol dose 0.3mg/Kg and Ciprofol dose 0.2mg/Kg in people with Elderly Patients, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
ciprofol is a recently introduced novel sedative drug. In comparison to the traditional propofol, ciprofol exhibits a higher affinity for GABA A receptors, approximately 4-5 times that of propofol, and possesses fewer side effects, particularly notable in respiratory depression and injection pain. Read more about this study
- Who is it for?
- Ages 65 to 105 years
- Conditions the study is for
- Elderly Patients
- What is being tested?
- Ciprofol dose 0.4mg/Kg, Ciprofol dose 0.3mg/Kg and Ciprofol dose 0.2mg/Kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 12 Feb 2025
- 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 105 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 ≤ age years;
- ASA physical state I and II;
- Hadn't a history of allergy to the drugs used in this study;
Who cannot join
- America Society of Anesthesiologists (ASA) class >III;
- Allergic to anesthetic solutions or the drugs used in this study;
- Body mass index (BMI) ≤ 20 or ≥ 30 kg/m2;
- Using hypnotics, opioid analgesics, or anti-anxiety medications;
- Known or suspected heart failure (ejection fraction <40%), severe respiratory disease, renal or metabolic disease
- Refuse to participate or participate with other clinical investigators ;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients: an Exploratory Study Based on Dixon's Up-and-Down Method
ciprofol is a recently introduced novel sedative drug. In comparison to the traditional propofol, ciprofol exhibits a higher affinity for GABA A receptors, approximately 4-5 times that of propofol, and possesses fewer side effects, particularly notable in respiratory depression and injection pain. In the context of general anesthesia induction, recent research has confirmed a 100% success rate in the induction of general anesthesia for elderly patients (65-80 years old) undergoing non-cardiac surgery with a dosage range of 0.2mg/kg-0.4mg/kg ciprofol. However, for elderly patients aged 65 and above, even up to 85 years old, it is currently not entirely clear what dosage should be selected for patients in different age groups. Consequently, we have designed this trial with the aim of exploring the dosage requirements of ciprofol during general anesthesia induction among elderly patients in various age brackets.
Methods: This is a prospective, non-controlled, non-randomized, single-blind study. Elderly patients aged 65 years and older were enrolled in the study with American Society of Anesthesiologists (ASA) physical status I or II undergoing general anesthesia. All patients were divided into five groups according to age, and the corresponding initial dose of ciprofol administered was selected according to the grouping, with subsequent doses of ciprofol determined according to the Dixon up-and-down method. At least seven crossover points were obtained before the conclusion of the study.The primary outcomes were the dose of ciprofol administered at the time of loss of consciousness (mg/Kg) and the plasma concentration of ciprofol.
Read the detailed description
After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (approval number IRB-2024-76(IIT)). The study was registered before patient enrollment in Clinicaltrials.Written informed consent was obtained from all participants. The study was performed from Jan 1, 2024 to Dec 31, 2025. 150 patients aged 65 years and above, ASA physical status I or II, undergoing surgery under general anesthesia and who were not allergic to the study drug were included in this study. Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. All patients were divided into five groups according to age, The initial dose of ciprofol for the first elderly patient was 0.2-0.4 mg/kg, the initial concentration was 0.4 mg/Kg for patients aged 65-74 years, 0.3 mg/Kg for patients aged 75-84 years, and 0.2 mg/Kg for patients aged 85 years or older, and the ciprofol doses for adjacent patients were set to be equidistantly spaced up and down by 0.05 mg/kg. Evaluation of the eyelash reflex and speech reflex was performed after intravenous infusion of ciprofol to observe whether LOC occurred within 4 min. After loss of consciousness, sufentanil (5ug/ml, diluted in 0.9% saline) and rocuronium bromide were given for endotracheal intubation.
- Conditions
- Elderly Patients
- Being tested
- Ciprofol dose 0.4mg/Kg, Ciprofol dose 0.3mg/Kg, Ciprofol dose 0.2mg/Kg
- Keywords
- Ciprofol, EC50, Los of consciousness, Elderly, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofol dose 0.4mg/KgDrug
Also called 0.4mg/Kg ciprofol
The initial dose of ciprofol was 0.4mg/Kg for induction in this group.
Ciprofol dose 0.3mg/KgDrug
Also called 0.3mg/Kg ciprofol
The initial dose of ciprofol was 0.3mg/Kg for induction in this group.
Ciprofol dose 0.2mg/KgDrug
Also called 0.2mg/Kg ciprofol
The initial dose of ciprofol was 0.2mg/Kg for induction in this group.
| Study group | Role | What they receive |
|---|---|---|
| 65-69 years old | Experimental | The initial dose of ciprofol was 0.4mg/ in this group. Receives: Drug: Ciprofol dose 0.4mg/Kg |
| 70-74 years old | Experimental | The initial dose of ciprofol was 0.4mg/ in this group. Receives: Drug: Ciprofol dose 0.4mg/Kg |
| 75-79 years old | Experimental | The initial dose of ciprofol was 0.3mg/ in this group. Receives: Drug: Ciprofol dose 0.3mg/Kg |
| 80-84 years old | Experimental | The initial dose of ciprofol was 0.3mg/ in this group. Receives: Drug: Ciprofol dose 0.3mg/Kg |
| Older than 85 years (include 85 years old) | Experimental | The initial dose of ciprofol was 0.2mg/ in this group. Receives: Drug: Ciprofol dose 0.2mg/Kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ciprofol EC50 (mg/Kg) for loss of consciousness
Use up-and-down method to evaluate the Ciprofol EC50 for loss of consciousness in different age groups.
Measured: From loss of consciousness (LOC) to 10 minutes after trachea intubation.
Secondary outcomes (4)
Plasma concentration of ciprofol when LOC.
Measure the plasma concentration of ciprofol when LOC.
Measured: From the start of induction to loss of consciousness, approximately 4 to 8 minutes after start of induction.
The mean artery pressure
Hemodynamic fluctuation during induction
Measured: From entering the OR to 10 minutes after trachea intubation.
The heart rate
Hemodynamic fluctuation during induction
Measured: From entering the OR to 10 minutes after trachea intubation.
Incidence of adverse events
Measuring and recording the adverse events such as hypotension, hypertension, bradycardia and tachycardia during induction period.
Measured: From entering the OR to 10 minutes after trachea intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start20 Apr 2024
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiangling, Zhejiang Cancer Hospital
- Investigators
- Ji Zhu, Dr., Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253078
- Sponsor's protocol ID
- IRB-2024-76（IIT）
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan can be shared when required.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciprofol EC50 for Inducing Loss of Consciousness in Elderly Patients: an Exploratory Study Based on Dixon's Up-and-Down Method
- ClinicalTrials.gov ID
- NCT06253078
- Acronym / sponsor ID
- IRB-2024-76（IIT）
- Conditions
- Elderly Patients
- Keywords
- Ciprofol, EC50, Los of consciousness, Elderly, General anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 12 Feb 2024 (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.
ciprofol is a recently introduced novel sedative drug. In comparison to the traditional propofol, ciprofol exhibits a higher affinity for GABA A receptors, approximately 4-5 times that of propofol, and possesses fewer side effects, particularly notable in respiratory depression and injection pain. In the context of general anesthesia induction, recent research has confirmed a 100% success rate in the induction of general anesthesia for elderly patients (65-80 years old) undergoing non-cardiac surgery with a dosage range of 0.2mg/kg-0.4mg/kg ciprofol. However, for elderly patients aged 65 and above, even up to 85 years old, it is currently not entirely clear what dosage should be selected for patients in different age groups. Consequently, we have designed this trial with the aim of exploring the dosage requirements of ciprofol during general anesthesia induction among elderly patients in various age brackets.
Methods: This is a prospective, non-controlled, non-randomized, single-blind study. Elderly patients aged 65 years and older were enrolled in the study with American Society of Anesthesiologists (ASA) physical status I or II undergoing general anesthesia. All patients were divided into five groups according to age, and the corresponding initial dose of ciprofol administered was selected according to the grouping, with subsequent doses of ciprofol determined according to the Dixon up-and-down method. At least seven crossover points were obtained before the conclusion of the study.The primary outcomes were the dose of ciprofol administered at the time of loss of consciousness (mg/Kg) and the plasma concentration of ciprofol.
Detailed description
After received the approvement of ethics committee of the Cancer Hospital of the University of Chinese Academy of Sciences (approval number IRB-2024-76(IIT)). The study was registered before patient enrollment in Clinicaltrials.Written informed consent was obtained from all participants. The study was performed from Jan 1, 2024 to Dec 31, 2025. 150 patients aged 65 years and above, ASA physical status I or II, undergoing surgery under general anesthesia and who were not allergic to the study drug were included in this study. Basic monitoring such as 3-lead electrocardiogram, pulse oximetry, and noninvasive blood pressure were arranged preoperatively. All patients were divided into five groups according to age, The initial dose of ciprofol for the first elderly patient was 0.2-0.4 mg/kg, the initial concentration was 0.4 mg/Kg for patients aged 65-74 years, 0.3 mg/Kg for patients aged 75-84 years, and 0.2 mg/Kg for patients aged 85 years or older, and the ciprofol doses for adjacent patients were set to be equidistantly spaced up and down by 0.05 mg/kg. Evaluation of the eyelash reflex and speech reflex was performed after intravenous infusion of ciprofol to observe whether LOC occurred within 4 min. After loss of consciousness, sufentanil (5ug/ml, diluted in 0.9% saline) and rocuronium bromide were given for endotracheal intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 65-69 years old | Experimental | Drug: Ciprofol dose 0.4mg/KgThe initial dose of ciprofol was 0.4mg/ in this group. |
| 70-74 years old | Experimental | Drug: Ciprofol dose 0.4mg/KgThe initial dose of ciprofol was 0.4mg/ in this group. |
| 75-79 years old | Experimental | Drug: Ciprofol dose 0.3mg/KgThe initial dose of ciprofol was 0.3mg/ in this group. |
| 80-84 years old | Experimental | Drug: Ciprofol dose 0.3mg/KgThe initial dose of ciprofol was 0.3mg/ in this group. |
| Older than 85 years (include 85 years old) | Experimental | Drug: Ciprofol dose 0.2mg/KgThe initial dose of ciprofol was 0.2mg/ in this group. |
Who may qualify
- Ages
- 65 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 ≤ age years;
- ASA physical state I and II;
- Hadn't a history of allergy to the drugs used in this study;
Key exclusion criteria (6 listed)
- America Society of Anesthesiologists (ASA) class >III;
- Allergic to anesthetic solutions or the drugs used in this study;
- Body mass index (BMI) ≤ 20 or ≥ 30 kg/m2;
- Using hypnotics, opioid analgesics, or anti-anxiety medications;
- Known or suspected heart failure (ejection fraction <40%), severe respiratory disease, renal or metabolic disease
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 |
|---|---|---|
| Ciprofol dose 0.4mg/KgAlso: 0.4mg/Kg ciprofolThe initial dose of ciprofol was 0.4mg/Kg for induction in this group. | Drug | 65-69 years old, 70-74 years old |
| Ciprofol dose 0.3mg/KgAlso: 0.3mg/Kg ciprofolThe initial dose of ciprofol was 0.3mg/Kg for induction in this group. | Drug | 75-79 years old, 80-84 years old |
| Ciprofol dose 0.2mg/KgAlso: 0.2mg/Kg ciprofolThe initial dose of ciprofol was 0.2mg/Kg for induction in this group. | Drug | Older than 85 years (include 85 years old) |
Primary outcome
Ciprofol EC50 (mg/Kg) for loss of consciousness
Time frame: From loss of consciousness (LOC) to 10 minutes after trachea intubation.
Use up-and-down method to evaluate the Ciprofol EC50 for loss of consciousness in different age groups.
4 secondary outcomes
Plasma concentration of ciprofol when LOC.
Time frame: From the start of induction to loss of consciousness, approximately 4 to 8 minutes after start of induction.
The mean artery pressure
Time frame: From entering the OR to 10 minutes after trachea intubation.
The heart rate
Time frame: From entering the OR to 10 minutes after trachea intubation.
Incidence of adverse events
Time frame: From entering the OR to 10 minutes after trachea intubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Plan can be shared when required.
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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.
Ji Zhu, Dr. study chair
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol dose 0.4mg/Kg, Ciprofol dose 0.3mg/Kg and Ciprofol dose 0.2mg/Kg in people with Elderly Patients, run by Zhejiang Cancer 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 3 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: finished, as of the sponsor's last update on 6 Oct 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ciprofol EC50 (mg/Kg) for loss of consciousness (time frame: From loss of consciousness (LOC) to 10 minutes after trachea intubation.). 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 6 Oct 2026.