Induction of General AnesthesiaPhase 4NCT06773351
A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane
A Phase 4 study testing Sevoflurane 0 + different doses of ciprofol, Sevoflurane 0.7% + different doses of ciprofol and Sevoflurane 1.0% + different doses of ciprofol 0.05 in people with Induction of General Anesthesia, run by Feng Gao.
Trial summary
Intravenous and inhalation combined anesthesia is a commonly used method for maintaining general anesthesia in clinical practice. This study aims to explore the interaction between ciprofol and sevoflurane. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Induction of General Anesthesia
- What is being tested?
- Sevoflurane 0 + different doses of ciprofol, Sevoflurane 0.7% + different doses of ciprofol and Sevoflurane 1.0% + different doses of ciprofol 0.05
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2025
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing elective general anesthesia and non-cardiac surgery;
- Age 18-60 years old, gender is not limited;
- ASA I or II level;
- Body mass index (BMI) 18-30 kg/m2
Who cannot join
- Preoperative assessment of potential difficult airway risk;
- Airway hyperreactivity;
- There is disease of the central nervous system or cardiovascular system;
- Currently using drugs that may alter the pharmacokinetics and pharmacokinetics of the drug under study;
- Known or suspected allergy or contraindication to the components or regimens of the investigational drug;
- A history of drug or alcohol addiction;
- Patients with gastroesophageal reflux disease;
- Severe liver and kidney dysfunction.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane During Anesthesia Induction
Intravenous and inhalation combined anesthesia is a commonly used method for maintaining general anesthesia in clinical practice. This study aims to explore the interaction between ciprofol and sevoflurane. By employing response surface methodology, we constructed a three-dimensional pharmacodynamic interaction surface for various dose combinations of ciprofol and sevoflurane. This approach allows us to determine the nature of the interaction between the two drugs at any given level, thereby providing a ciprofol understanding of the dose-response relationship when ciprofol and sevoflurane are used in combination. This knowledge will serve as a theoretical basis for rational drug administration during surgery.
- Conditions
- Induction of General Anesthesia
- Being tested
- Sevoflurane 0 + different doses of ciprofol, Sevoflurane 0.7% + different doses of ciprofol, Sevoflurane 1.0% + different doses of ciprofol 0.05, Sevoflurane 1.5% + differnet doses of ciprofol, Sevoflurane 2.0% + different doses of ciprofol
- Keywords
- ciprofol, response surface analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane 0 + different doses of ciprofolDrug
Sevoflurane 0% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.6mg/kg, respectively.
Sevoflurane 0.7% + different doses of ciprofolDrug
Sevoflurane 0.7% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.5mg/kg, respectively.
Sevoflurane 1.0% + different doses of ciprofol 0.05Drug
Sevoflurane 1.0% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively.
Sevoflurane 1.5% + differnet doses of ciprofolDrug
Sevoflurane 1.5% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively.
Sevoflurane 2.0% + different doses of ciprofolDrug
Sevoflurane 2.0% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively.
Sevoflurane 2.5% + different doses of ciprofolDrug
Sevoflurane 2.5% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively.
Ciprofol 0 + different end-expiratory concentration of sevofluraneDrug
Ciprofol 0 combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5%, respectively.
Ciprofol 0.05mg/kg + different end-expiratory concentration of sevofluraneDrug
Ciprofol 0.05 mg/kg combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5 %, respectively.
Ciprofol 0.1mg/kg + different end-expiratory concentration of sevofluraneDrug
Ciprofol 0.1mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively.
Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevofluraneDrug
Ciprofol 0.2 mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively.
Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevofluraneDrug
Ciprofol 0.3 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively.
Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevofluraneDrug
Ciprofol 0.4 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane group | Experimental | Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5% Receives: Drug: Sevoflurane 0 + different doses of ciprofol; Drug: Sevoflurane 0.7% + different doses of ciprofol; Drug: Sevoflurane 1.0% + different doses of ciprofol 0.05; Drug: Sevoflurane 1.5% + differnet doses of ciprofol; Drug: Sevoflurane 2.0% + different doses of ciprofol; Drug: Sevoflurane 2.5% + different doses of ciprofol |
| ciprofol group | Experimental | The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg Receives: Drug: Ciprofol 0 + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral Index (BIS) value
The BIS usually ranges from 0 to 100, with 0-20 indicating a state of deep anesthesia or coma; 20-40 indicates moderate anesthesia; 40-60 indicates mild anesthesia; 60-80 indicates sedation; 80-100 indicates wakefulness.
Measured: Induction period of anesthesia
The score of Observer's Assessment of Alertness/Sedation Scale
The Observer's Assessment of Alertness/Sedation (OAAS) scale ranges from 1 to 5 points.
5 (awake) : The patient responds quickly to the name call with normal intonation, normal verbal answers, normal facial expressions, and bright eyes without drooping.
4 (mild sedation) : The patient is slow to respond to the name call in normal intonation, the verbal answer is slightly slow or vague, the facial expression is slightly relaxed, the eyes are glassy and the upper eyelid is slightly droopy.
3 (moderate sedation) : The patient responds only to the name call out loud, verbal responses are significantly slower or slower, facial expressions are significantly relaxed, and eyes are fixed with a visibly droopy upper eyelid.
2 (deep sedation) : The patient responds only to nudging or shaking, and the verbal response is indistinct.
1 (deep sleep, unconscious) : The patient does not respond to nudging or shaking.
An OAA/S score of 2-5 is considered a response.
Measured: Induction period of anesthesia
Numbers of of participants with laryngoscopy and tracheal intubation positive response
Laryngoscopic exposure of the glottis to obtain Cormack-Lehane level 1 or 2 visual field and maintain it for 5 seconds: verbal response, eye opening, painful expression, coughing, retraction, or other purposeful or unpurposeful movements are considered responsive.
Measured: Induction period of anesthesia
Numbers of participants with tracheal intubation stress positive respose
If the increase in heart rate (HR) or mean arterial pressure (MAP) compared to the baseline value was greater than or equal to 15% during this procedure, the stress response induced by tracheal intubation was considered to have failed to be effectively suppressed, and the effect was recorded as 1.
Measured: Induction period of anesthesia
Blood plasma concentration
Measured: Induction period of anesthesia
Secondary outcomes (3)
HR
For adults, the normal heart rate range is usually between 60 and 100 beats per minute. During anesthesia, HR less than 20% of baseline is considered hypotensive
Measured: Period of anesthesia
MAP
The normal range of MAP is usually 70-105 mmHg. MAP is one of the important indicators to measure the function of the human circulatory system, which represents the average arterial blood pressure in a cardiac cycle. During anesthesia, MSP less than 20% of baseline is considered hypotensive.
Measured: Period of anesthesia
Adverse reactions
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of General AnesthesiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773351
- Sponsor's protocol ID
- TJ-IRB202412125
- Other IDs
- S219
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane During Anesthesia Induction
- ClinicalTrials.gov ID
- NCT06773351
- Acronym / sponsor ID
- TJ-IRB202412125
- Conditions
- Induction of General Anesthesia
- Keywords
- ciprofol, response surface analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Collaborators
- Sichuan Provincial People's Hospital
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jan 2025 (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.
Intravenous and inhalation combined anesthesia is a commonly used method for maintaining general anesthesia in clinical practice. This study aims to explore the interaction between ciprofol and sevoflurane. By employing response surface methodology, we constructed a three-dimensional pharmacodynamic interaction surface for various dose combinations of ciprofol and sevoflurane. This approach allows us to determine the nature of the interaction between the two drugs at any given level, thereby providing a ciprofol understanding of the dose-response relationship when ciprofol and sevoflurane are used in combination. This knowledge will serve as a theoretical basis for rational drug administration during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane group | Experimental | Drug: Sevoflurane 0 + different doses of ciprofol, Drug: Sevoflurane 0.7% + different doses of ciprofol, Drug: Sevoflurane 1.0% + different doses of ciprofol 0.05, Drug: Sevoflurane 1.5% + differnet doses of ciprofol, Drug: Sevoflurane 2.0% + different doses of ciprofol, Drug: Sevoflurane 2.5% + different doses of ciprofolSevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5% |
| ciprofol group | Experimental | Drug: Ciprofol 0 + different end-expiratory concentration of sevoflurane, Drug: Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane, Drug: Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane, Drug: Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane, Drug: Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevoflurane, Drug: Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevofluraneThe doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients undergoing elective general anesthesia and non-cardiac surgery;
- Age 18-60 years old, gender is not limited;
- ASA I or II level;
- Body mass index (BMI) 18-30 kg/m2
Key exclusion criteria (8 listed)
- Preoperative assessment of potential difficult airway risk;
- Airway hyperreactivity;
- There is disease of the central nervous system or cardiovascular system;
- Currently using drugs that may alter the pharmacokinetics and pharmacokinetics of the drug under study;
- Known or suspected allergy or contraindication to the components or regimens of the investigational drug;
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 |
|---|---|---|
| Sevoflurane 0 + different doses of ciprofolSevoflurane 0% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.6mg/kg, respectively. | Drug | sevoflurane group |
| Sevoflurane 0.7% + different doses of ciprofolSevoflurane 0.7% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.5mg/kg, respectively. | Drug | sevoflurane group |
| Sevoflurane 1.0% + different doses of ciprofol 0.05Sevoflurane 1.0% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively. | Drug | sevoflurane group |
| Sevoflurane 1.5% + differnet doses of ciprofolSevoflurane 1.5% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively. | Drug | sevoflurane group |
| Sevoflurane 2.0% + different doses of ciprofolSevoflurane 2.0% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively. | Drug | sevoflurane group |
| Sevoflurane 2.5% + different doses of ciprofolSevoflurane 2.5% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively. | Drug | sevoflurane group |
| Ciprofol 0 + different end-expiratory concentration of sevofluraneCiprofol 0 combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5%, respectively. | Drug | ciprofol group |
| Ciprofol 0.05mg/kg + different end-expiratory concentration of sevofluraneCiprofol 0.05 mg/kg combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5 %, respectively. | Drug | ciprofol group |
| Ciprofol 0.1mg/kg + different end-expiratory concentration of sevofluraneCiprofol 0.1mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively. | Drug | ciprofol group |
| Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevofluraneCiprofol 0.2 mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively. | Drug | ciprofol group |
| Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevofluraneCiprofol 0.3 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively. | Drug | ciprofol group |
| Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevofluraneCiprofol 0.4 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively. | Drug | ciprofol group |
Primary outcome
Bispectral Index (BIS) value
Time frame: Induction period of anesthesia
The BIS usually ranges from 0 to 100, with 0-20 indicating a state of deep anesthesia or coma; 20-40 indicates moderate anesthesia; 40-60 indicates mild anesthesia; 60-80 indicates sedation; 80-100 indicates wakefulness.
The score of Observer's Assessment of Alertness/Sedation Scale
Time frame: Induction period of anesthesia
The Observer's Assessment of Alertness/Sedation (OAAS) scale ranges from 1 to 5 points. 5 (awake) : The patient responds quickly to the name call with normal intonation, normal verbal answers, normal facial expressions, and bright eyes without drooping. 4 (mild sedation) : The patient is slow to respond to the name call in normal intonation, the verbal answer is slightly slow or vague, the facial expression is slightly relaxed, the eyes are glassy and the upper eyelid is slightly droopy. 3 (moderate sedation) : The patient responds only to the name call out loud, verbal responses are significantly slower or slower, facial expressions are significantly relaxed, and eyes are fixed with a visibly droopy upper eyelid. 2 (deep sedation) : The patient responds only to nudging or shaking, and the verbal response is indistinct. 1 (deep sleep, unconscious) : The patient does not respond to nudging or shaking. An OAA/S score of 2-5 is considered a response.
Numbers of of participants with laryngoscopy and tracheal intubation positive response
Time frame: Induction period of anesthesia
Laryngoscopic exposure of the glottis to obtain Cormack-Lehane level 1 or 2 visual field and maintain it for 5 seconds: verbal response, eye opening, painful expression, coughing, retraction, or other purposeful or unpurposeful movements are considered responsive.
Numbers of participants with tracheal intubation stress positive respose
Time frame: Induction period of anesthesia
If the increase in heart rate (HR) or mean arterial pressure (MAP) compared to the baseline value was greater than or equal to 15% during this procedure, the stress response induced by tracheal intubation was considered to have failed to be effectively suppressed, and the effect was recorded as 1.
Blood plasma concentration
Time frame: Induction period of anesthesia
3 secondary outcomes
HR
Time frame: Period of anesthesia
MAP
Time frame: Period of anesthesia
Adverse reactions
Time frame: Perioperative period
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 14 Jan 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane 0 + different doses of ciprofol, Sevoflurane 0.7% + different doses of ciprofol and Sevoflurane 1.0% + different doses of ciprofol 0.05 in people with Induction of General Anesthesia, run by Feng Gao.
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 4 inclusion and 8 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 Feng Gao, PhD (+86 13971587381, fgao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bispectral Index (BIS) value (time frame: Induction period of anesthesia). The study lists 5 primary outcomes in all. 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 14 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.