AnesthesiaPhase 4NCT05706337
Clinical Observation of Ciprofol for Anesthesia Induction
A Phase 4 study testing Propofol and Ciprofol in people with Anesthesia and Pain, run by Xiumei Song.
Trial summary
To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia, Pain, Hemodynamic Instability
- What is being tested?
- Propofol and Ciprofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ASA physical status Ⅰ-Ⅲ
- Age over 65 years;
- Body mass index (BMI) 20 ~ 30 kg/m2 ;
- Elective noncardiac surgery;
Who cannot join
- The patient or his/her family refused to participate in the clinical trial;
- Severe heart, lung, liver or kidney dysfunction;
- Expected difficult airway, requiring awake tracheal intubation;
- Those who are allergic to the drugs used in this study;
- Unsuccessful tracheal intubation twice;
- Patients with mental illness or impaired consciousness;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery
To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.
Read the detailed description
90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 ~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.
- Conditions
- Anesthesia, Pain, Hemodynamic Instability
- Being tested
- Propofol, Ciprofol
- Keywords
- Anesthesia induction, Ciprofol, propofol, Injection pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.
CiprofolDrug
Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Active comparator | According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil. Receives: Drug: Propofol |
| ciprofol group | Experimental | According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups. Receives: Drug: Ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic changes：Systolic blood pressure (SBP)
Systolic blood pressure (SBP) during anesthesia induction
Measured: From the beginning of drug administration to 30 minutes after intubation
Hemodynamic changes: Diastolic blood pressure(DBP)
Diastolic blood pressure(DBP) during anesthesia induction
Measured: From the beginning of drug administration to 30 minutes after intubation
Hemodynamic changes: Heart rate （HR ）
Heart rate （HR ）during anesthesia induction
Measured: From the beginning of drug administration to 30 minutes after intubation
Secondary outcomes (8)
adverse reactions: injection pain
injection pain from propofol or ciprofol intravenous injection
Measured: anesthesia induction
adverse reactions: muscle fasciculation
muscle fasciculation induced by propofol or ciprofol intravenous induction
Measured: anesthesia induction
adverse reactions：arrhythmia
arrhythmia induced by propofol or ciprofol intravenous induction
Measured: anesthesia induction
perioperative hepatic function: Aspartate Aminotransferase ( AST)
level of Aspartate Aminotransferase ( AST)
Measured: Before surgery , 1day after operation
perioperative hepatic function: Alanine Aminotransferase ( ALT)
level of Alanine Aminotransferase ( ALT)
Measured: Before surgery , 1day after operation
perioperative renal function: creatine
level of creatine
Measured: Before surgery , 1day after operation
perioperative renal function:Blood Urea Nitrogen
level of Blood Urea Nitrogen（BUN)
Measured: Before surgery , 1day after operation
Monitoring Depth of Anesthesia
BIS values
Measured: anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiumei Song
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiumei Song, Qianfoshan Hospital
- Investigators
- Xiumei Song, Doctor, Study chair, Qian fo shan hospitial of shan dong province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706337
- Sponsor's protocol ID
- YXLL-KY-2022(060)
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to upload and share data with other researchers. Protecting patient privacy when sharing patient-level data from clinical trial
Publications
Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
PubMed 34116176Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
PubMed 35302207Qin K, Qin WY, Ming SP, Ma XF, Du XK. Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292.
PubMed 35916802
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT05706337
- Acronym / sponsor ID
- YXLL-KY-2022(060)
- Conditions
- Anesthesia, Pain, Hemodynamic Instability
- Keywords
- Anesthesia induction, Ciprofol, propofol, Injection pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xiumei SongUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Jan 2023 (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.
To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.
Detailed description
90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 ~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol group | Active comparator | Drug: PropofolAccording to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil. |
| ciprofol group | Experimental | Drug: CiprofolAccording to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ASA physical status Ⅰ-Ⅲ
- Age over 65 years;
- Body mass index (BMI) 20 ~ 30 kg/m2 ;
- Elective noncardiac surgery;
Key exclusion criteria (6 listed)
- The patient or his/her family refused to participate in the clinical trial;
- Severe heart, lung, liver or kidney dysfunction;
- Expected difficult airway, requiring awake tracheal intubation;
- Those who are allergic to the drugs used in this study;
- Unsuccessful tracheal intubation twice;
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 |
|---|---|---|
| PropofolPropofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus. | Drug | propofol group |
| CiprofolCiprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain. | Drug | ciprofol group |
Primary outcome
Hemodynamic changes：Systolic blood pressure (SBP)
Time frame: From the beginning of drug administration to 30 minutes after intubation
Systolic blood pressure (SBP) during anesthesia induction
Hemodynamic changes: Diastolic blood pressure(DBP)
Time frame: From the beginning of drug administration to 30 minutes after intubation
Diastolic blood pressure(DBP) during anesthesia induction
Hemodynamic changes: Heart rate （HR ）
Time frame: From the beginning of drug administration to 30 minutes after intubation
Heart rate （HR ）during anesthesia induction
8 secondary outcomes
adverse reactions: injection pain
Time frame: anesthesia induction
adverse reactions: muscle fasciculation
Time frame: anesthesia induction
adverse reactions：arrhythmia
Time frame: anesthesia induction
perioperative hepatic function: Aspartate Aminotransferase ( AST)
Time frame: Before surgery , 1day after operation
perioperative hepatic function: Alanine Aminotransferase ( ALT)
Time frame: Before surgery , 1day after operation
perioperative renal function: creatine
Time frame: Before surgery , 1day after operation
perioperative renal function:Blood Urea Nitrogen
Time frame: Before surgery , 1day after operation
Monitoring Depth of Anesthesia
Time frame: anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 34116176Teng Y, Ou M, Wang X, Zhang W, Liu X, Liang Y, Li K, Wang Y, Ouyang W, Weng H, Li J, Yao S, Meng J, Shangguan W, Zuo Y, Zhu T, Liu B, Liu J. Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials. Eur J Pharm Sci. 2021 Sep 1;164:105904. doi: 10.1016/j.ejps.2021.105904. Epub 2021 Jun 8.
- Background: PubMed 35302207Wang X, Wang X, Liu J, Zuo YX, Zhu QM, Wei XC, Zou XH, Luo AL, Zhang FX, Li YL, Zheng H, Li H, Wang S, Wang DX, Guo QL, Liu CM, Wang YT, Zhu ZQ, Wang GY, Ai YQ, Xu MJ. Effects of ciprofol for the induction of general anesthesia in patients scheduled for elective surgery compared to propofol: a phase 3, multicenter, randomized, double-blind, comparative study. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1607-1617. doi: 10.26355/eurrev_202203_28228.
- Background: PubMed 35916802Qin K, Qin WY, Ming SP, Ma XF, Du XK. Effect of ciprofol on induction and maintenance of general anesthesia in patients undergoing kidney transplantation. Eur Rev Med Pharmacol Sci. 2022 Jul;26(14):5063-5071. doi: 10.26355/eurrev_202207_29292.
- Individual participant dataSharing planned: Yes. We plan to upload and share data with other researchers. Protecting patient privacy when sharing patient-level data from clinical trial
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Xiumei Song, Doctor study chair
Qian fo shan hospitial of shan dong province, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Ciprofol in people with Anesthesia and Pain, run by Xiumei Song.
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 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiumei Song, Doctor (+8613969050425, ssm801117@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic changes：Systolic blood pressure (SBP) (time frame: From the beginning of drug administration to 30 minutes after intubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706337, which also lists 3 linked publications.
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 31 Jan 2023.