Painless Hysteroscopy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGCiprofol
The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911).
DRUGPropofol
The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).
Sponsors
Baoding First Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years old; 2. undergoing hysteroscopy examination and requiring intravenous anesthesia; 3. American Society of Anesthesiologists (ASA) physical status I to II; 4. without communication difficulties, and able to cooperate with intervention implementation; 5. participating in this trial voluntarily, and signing an informed consent form;
Exclusion criteria
1. 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; 2. with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases; 3. with a history of uterine surgery within the past three months; 4. body temperature above 37.5 ℃ before the anesthesia; 5. long-term use of sedative or analgesic drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia success rate | 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 | 24 hours within hysteroscopy | the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1 |
| recovery time | 24 hours within hysteroscopy | the time from the last administration of investigational drugs to awaken |
| use of rescue drugs | 24 hours within hysteroscopy | ephedrine, atropine |
| Sedation success rate | 24 hours within hysteroscopy | No more than 5 supplementary doses within 15 minutes |
| adverse events | 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 | 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 | 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 | 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) |
| times of supplementing ciprofol or propofol | 24 hours within hysteroscopy | times of supplementing ciprofol or propofol |
Contacts
Primary ContactLei Zhu
Outcome results
None listed