ciprofol
DrugThe experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911).
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NCT Number: NCT06413862
Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
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.
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Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- age ≥ 18 years old;
- undergoing hysteroscopy examination and requiring intravenous anesthesia;
- American Society of Anesthesiologists (ASA) physical status I to II;
- without communication difficulties, and able to cooperate with intervention implementation;
- participating in this trial voluntarily, and signing an informed consent form;
Exclusion criteria
- with contraindications for hysteroscopy examination (such as cervical stenosis, difficulty in cervical dilation, reproductive tract infections such as vaginitis and cervicitis) or allergies to the intended anesthetic drugs;
- with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases;
- with a history of uterine surgery within the past three months;
- body temperature above 37.5 ℃ before the anesthesia;
- long-term use of sedative or analgesic drugs.
Treatment and study plan
Propofol
DrugThe control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).
Primary outcomes
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Injection pain
Time frame: 24 hours within hysteroscopy
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).
Secondary outcomes
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Sedation success rate
Time frame: 24 hours within hysteroscopy
No more than 5 supplementary doses within 15 minutes
-
Anesthesia success rate
Time frame: 24 hours within hysteroscopy
the absence of any alternative sedatives/anesthetic drugs after the initial administration of the investigational drugs
-
time for successful anesthesia induction
Time frame: 24 hours within hysteroscopy
the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1
-
recovery time
Time frame: 24 hours within hysteroscopy
the time from the last administration of investigational drugs to awaken
-
use of rescue drugs
Time frame: 24 hours within hysteroscopy
ephedrine, atropine
-
times of supplementing ciprofol or propofol
Time frame: 24 hours within hysteroscopy
times of supplementing ciprofol or propofol
-
adverse events
Time frame: 24 hours within hysteroscopy
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
-
severity level of adverse events
Time frame: 24 hours within hysteroscopy
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)
-
patient satisfaction
Time frame: 24 hours within hysteroscopy
using a 10-point scale, with 1 point indicating extreme dissatisfaction and 10 points indicating very satisfied
-
comparison of vital signs before and after administration
Time frame: 24 hours within hysteroscopy
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)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Baoding First Central Hospital
Other
Registry information
Official study title
Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
Important dates
- Study start
- 2024
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- May 14, 2024
- Registry last updated
- Aug 7, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.