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Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.
In this study, we found that sedation success rate was 100% in both ciprofol group and propofol group during the painless hysteroscopy. The incidence rate of injection pain and the intensity of pain in the ciprofol group were significantly lower than the propofol group. Also, the ciprofol group had lower incidence rate and severity level of adverse events and higher patient satisfaction. In addition, SBP, DBP, and MAP values in propofol group were found to be significantly lower than those in ciprofol group at the time of cervical dilation and of consciousness recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofol group (ciprofol combined with alfentanil) | Experimental |
| |
| Propofol group (propofol combined with alfentanil) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofol | Drug | The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Injection pain | The injection pain was defined as the pain reported verbally by patients during the first injection of the investigational drugs (ciprofol or propofol). The Numerical Rating Scale (NRS) was used to evaluate the pain level. The anesthesiologist asks the patient during the first injection of the investigational drug (ciprofol or propofol), "Do you feel arm pain from the injection? Patients who answered "yes" was asked to describe the level of the pain (a score of 0 to 10 indicated "painless" to "unbearable pain"). The pain level was divided into painless (0 points), mild pain (1-3 points), and moderate to severe pain (4-10 points). | 24 hours within hysteroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation success rate | No more than 5 supplementary doses within 15 minutes | 24 hours within hysteroscopy |
| Anesthesia success rate | the absence of any alternative sedatives/anesthetic drugs after the initial administration of the investigational drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Zhu | Contact | +86-13785214850 | zhuleizlzl@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhu | the First Central Hospital of Baoding | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39533194 | Derived | Li A, Li N, Zhu L, Xu Z, Wang Y, Li J, Zhang G. The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2024 Nov 12;24(1):411. doi: 10.1186/s12871-024-02787-0. |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914). |
|
| 24 hours within hysteroscopy |
| time for successful anesthesia induction | the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1 | 24 hours within hysteroscopy |
| recovery time | the time from the last administration of investigational drugs to awaken | 24 hours within hysteroscopy |
| use of rescue drugs | ephedrine, atropine | 24 hours within hysteroscopy |
| times of supplementing ciprofol or propofol | times of supplementing ciprofol or propofol | 24 hours within hysteroscopy |
| adverse events | nausea, vomiting, hypoxemia (blood oxygen saturation < 90% and lasting > 30 seconds), bradycardia (heart rate < 55 beats/minute), hypotension (systolic blood pressure reduced by 20% compared to baseline), body movement (patient's unconscious limb movements) during the examination | 24 hours within hysteroscopy |
| severity level of adverse events | graded based the National Cancer Institute Common Terminology Criteria for the Classification of Adverse Events (CTCAE) version 5.0, and divided into grade 1 (mild), grade 2 (moderate), grade 3 (severe or medically significant but not immediately life threatening), grade 4 (events with life-threatening consequences needing urgent intervention), grade 5 (death related to the adverse events) | 24 hours within hysteroscopy |
| patient satisfaction | using a 10-point scale, with 1 point indicating extreme dissatisfaction and 10 points indicating very satisfied | 24 hours within hysteroscopy |
| comparison of vital signs before and after administration | The systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, blood oxygen saturation in %, and heart rate in bpm were recorded before anesthesia induction (T0), after anesthesia induction (T1), at cervical dilation (T2), and at consciousness recovery (T3) | 24 hours within hysteroscopy |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |