Gynecological Outpatient SurgeryPhase 3NCT04958746

Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries

A Phase 3 study testing Ciprofol and Propofol in people with Gynecological Outpatient Surgery, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Gynecological Outpatient Surgery
What is being tested?: Ciprofol and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 1 siteChina
Study dates: 26 Jul 2021to 30 Sep 2021
Phase: Phase 3
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 18 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient needing gynecological outpatient surgery under general anesthesia without endotracheal intubation;
Female, aged between 18-65 (inclusive);
American Society of Anesthesiologists (ASA) Class I- II
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
Vital signs during the screening period meet the following criteria:
Respiratory rate ≥ 10 and ≤ 24 breaths/min;

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Pulse oxygen saturation (SpO2) ≥ 95% when inhaling;
Systolic blood pressure (SBP) ≥ 85 mmHg and ≤ 140 mmHg;
Diastolic blood pressure (DBP) ≥ 50 mmHg and ≤ 90 mmHg;
Heart rate ≥ 50 beats/min and ≤ 100 beats/min. (Note: For heart rate, the heart rate results of 12-ECG examination are used as the basis for judging whether the inclusion criteria are met.)
Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.

Who cannot join

Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
Known sensitivity to Propofol Injection, Ciprofol Injection, the excipients in the investigational drugs (soybean oil, glycerin, triglyceride, egg lecithin, purified lecithin, sodium oleate, sodium hydroxide and disodium edetate), and opioids or any ingredient of opioids; contraindications to Propofol;
Patients with positive urine HCG or blood HCG (except abortion, dilatation and curettage, other outpatient surgeries for termination of pregnancy);
Patients having the following medical history or evidence prior to screening, which may increase sedation/anesthesia risk:
History of cardiovascular diseases: Uncontrolled hypertension or SBP > 140 mmHg and/or DBP > 90 mmHg despite antihypertensive treatment, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction within 6 months prior to screening, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥ 450 ms (Fridericia's correction formula) during screening;
Respiratory system disorders: Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory tract infection with any one of the obvious symptoms such as fever, wheezing, or productive cough within 1 week prior to screening;

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History of neurological and mental disorders: history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; history of schizophrenia, mania, chronic use of antipsychotics, cognitive impairment, etc.;
History of gastrointestinal diseases: history of gastrointestinal retention, active hemorrhage, gastroesophageal reflux or obstruction, etc. which may cause reflux and aspiration, as per the judgment of the investigator;
History of uncontrolled and clinically significant diseases in such as liver, kidney, blood system, nervous system, or metabolic system judged by the investigator to be unsuitable for this trial;
History of alcohol abuse within 3 months prior to screening, abuse defined as average of > 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine);
History of drug abuse within 3 months prior to screening;
Serious infection, trauma, or major surgery within 4 weeks prior to screening.
Patients with the following airway management risks at screening:
Asthma history, and stridor;
Sleep apnea syndrome;
History or family history of malignant hyperthermia;
History of intubation failure;
Judged by the investigator to have difficult airway or judged as difficult tracheal intubation (modified Mallampati score III or IV).
Receiving any one of the following medications or treatments at screening:
Participated in other clinical trials of drugs within 1 month prior to screening;
Used Propofol, other general sedatives/anesthetics, and/or opioid analgesics or compounds containing opioid analgesics within 3 days prior to screening.
Patient whose laboratory parameters measured at screening meet any of the following criteria and are verified through reexamination:
Neutrophil count < 1.5 × 109/L;
Platelet count < 80 × 109/L;
Hemoglobin < 90 g/L;
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3.0 × upper limit of normal (ULN)
Total bilirubin > 2 × ULN;
Serum creatinine > 1.5 × ULN.
Breastfeeding females; women of child-bearing potential who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 1 month after completion of the trial.
Subject judged by the investigator to have any other factors unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing

Other trials in China

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Propofol Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries

This study is a multi-center, randomized, double-blind, Propofol parallel-controlled phase III clinical study, with the primary objective of evaluating the efficacy of Ciprofol vs. Propofol for the induction of sedation/anesthesia in subjects undergoing gynecological outpatient surgeries and secondary objective of evaluating the safety of Ciprofol in subjects undergoing gynecological outpatient surgeries.

Conditions: Gynecological Outpatient Surgery
Being tested: Ciprofol, Propofol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CiprofolDrug
intravenous bolus
PropofolDrug
intravenous bolus

Study groups in NCT04958746
Study group	Role	What they receive
Ciprofol	Experimental	Ciprofol group：0.4/0.2mg/kg Receives: Drug: Ciprofol
Propofol	Placebo comparator	Propofol group：2.0/1.0mg/kg Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

Success rate of anesthesia
The proportion of subjects successfully anesthetized in all subjects of the group.
Measured: Day 1

Secondary outcomes (4)

Time to successful sedation/anesthetic induction
Time from the initial administration of the investigational drug to the first time when MOAA/S is ≤ 1
Measured: Day 1
Time to full recovery:
Time from the last administration of the investigational drug to the first of 3 consecutive MOAA/S scores = 5
Measured: Day 1
Time to discharge
The time from the last administration of the investigational products to the first of 3 consecutive Aldrete scores of ≥ 9
Measured: Day 1
Sedation/anesthesia satisfaction, including satisfaction evaluation of subjects, anesthesiologists, and surgeons.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202130 Sep 2021

First posted12 Jul 2021
Study start26 Jul 2021
Primary completion29 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gynecological Outpatient SurgeryStudies of the same condition, open and under way.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04958746
Sponsor's protocol ID: HSK3486-308
Status last verified: May 2022
First submitted: 23 Jun 2021
Last updated: 2 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xu J, Yang M, Zeng Y, Zou XH, Ren JH, Xia Z, Xie HH, Yu YH, Xu MJ, Chen W, Wang DX. Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial. Front Med (Lausanne). 2024 Apr 23;11:1360508. doi: 10.3389/fmed.2024.1360508. eCollection 2024.
PubMed 38716419

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind, Propofol Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries
ClinicalTrials.gov ID: NCT04958746
Acronym / sponsor ID: HSK3486-308
Conditions: Gynecological Outpatient Surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Jul 2021 (actual)
Primary completion: 29 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 12 Jul 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ciprofol	Experimental	Drug: CiprofolCiprofol group：0.4/0.2mg/kg
Propofol	Placebo comparator	Drug: PropofolPropofol group：2.0/1.0mg/kg

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patient needing gynecological outpatient surgery under general anesthesia without endotracheal intubation;
Female, aged between 18-65 (inclusive);
American Society of Anesthesiologists (ASA) Class I- II
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
Vital signs during the screening period meet the following criteria:

Key exclusion criteria (30 listed)

Patients with contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
Known sensitivity to Propofol Injection, Ciprofol Injection, the excipients in the investigational drugs (soybean oil, glycerin, triglyceride, egg lecithin, purified lecithin, sodium oleate, sodium hydroxide and disodium edetate), and opioids or any ingredient of opioids; contraindications to Propofol;
Patients with positive urine HCG or blood HCG (except abortion, dilatation and curettage, other outpatient surgeries for termination of pregnancy);
Patients having the following medical history or evidence prior to screening, which may increase sedation/anesthesia risk:
Patients with the following airway management risks at screening:

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
Ciprofolintravenous bolus	Drug	Ciprofol
Propofolintravenous bolus	Drug	Propofol

Primary outcome

Success rate of anesthesia
Time frame: Day 1
The proportion of subjects successfully anesthetized in all subjects of the group.

4 secondary outcomes

Time to successful sedation/anesthetic induction
Time frame: Day 1
Time to full recovery:
Time frame: Day 1
Time to discharge
Time frame: Day 1
Sedation/anesthesia satisfaction, including satisfaction evaluation of subjects, anesthesiologists, and surgeons.
Time frame: Day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
Derived from this study: PubMed 38716419Xu J, Yang M, Zeng Y, Zou XH, Ren JH, Xia Z, Xie HH, Yu YH, Xu MJ, Chen W, Wang DX. Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial. Front Med (Lausanne). 2024 Apr 23;11:1360508. doi: 10.3389/fmed.2024.1360508. eCollection 2024.

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.

Dongxin Wang principal investigator

Peking University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciprofol and Propofol in people with Gynecological Outpatient Surgery, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

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 11 inclusion and 30 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: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of anesthesia (time frame: Day 1). 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 NCT04958746, which also lists 1 linked publication.

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 2 Jun 2022.