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Gastric UlcerPhase 4SpO2NCT05518929

Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients

A Phase 4 study testing Ciprofol and Propofol in people with Gastric Ulcer and Gastric Cancer, run by RenJi Hospital at 5 sites 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

Ciprofol is a new general anesthetic, which combine with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ciprofol and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,090 participants
Where
5 sitesChina
Study dates
8 Sep 2022to 30 Aug 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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age, ≤18 and ≤80 years, no gender limit
  • Undergoing routine gastrointestinal endoscopic diagnosis and treatment
  • American Society of Aneshesiologists (ASA) classification I-II
  • Body mass index (BMI) ≥ 23kg/m2
  • Estimated procedure duration less than 30 min
  • Clearly understand and voluntarily participate in the study; provide signed informed consent

Who cannot join

  • Need to perform complicated endoscopic techniques for diagnosis and treatment, such as cholangiopancreatography surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa stripping, and oral endoscopic muscle dissection
  • Intend to undergo tracheal intubation or laryngeal mask
  • Patients' SpO2 ≤ 95% after entering the endoscope room;
  • Be definitely diagnosed as obstructive sleep apnea hypopnea syndrome;
  • Body weight < 40kg
  • Have serious heart diseases such as severe arrhythmia, heart failure, Adams-Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance < 4mets
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  • Systolic blood pressure ≥ 180mmhg or / and diastolic blood pressure ≥ 110mmhg measured in the endoscope room
  • Respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months, acute respiratory tract infection within 1 week, and obvious symptoms such as fever, wheezing, nasal congestion and cough
  • There is an uncontrolled disease history with significant clinical significance, such as liver, kidney, blood system, nervous system or metabolic system, which may not be suitable for participating in the study
  • Pregnant or breast-feeding women
  • Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
  • Participated in other clinical trials as a subject within 3 months
  • Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
  • Patients with brain injury, possible convulsion, myoclonus, intracranial hypertension, cerebral aneurysm, cerebrovascular accident history, schizophrenia, intellectual disability, mania, psychosis, long-term use of psychotropic drugs, drug addiction, cognitive dysfunction history, etc.
  • Patients who the investigator considers inappropriate to participate in this trial

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 10000

  • Dalian Municipal Friendship Hospital

    Dalian, Liaoning

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Zhejiang Tumor Hospital

    Zhejiang, Hangzhou, 310000

Other trials in China

About this study

Official title: The Incidences Of Hypoxia And Severe Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol Compared With Propofol In Overweight Or Obesity Adults Patients, A Multicenter, Randomized, Controlled Trial

Ciprofol is a new general anesthetic, which combine with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in the sedation for gastrointestinal endoscopy, especially for overweight and obese patients. We conduct a Multicenter, Randomized, Open-label, Propofol-controlled Study to Evaluate the incidence of hypoxia and severe hypoxia during Gastroenterological Endoscope sedated with CiProfol in Overweight or Obesity patients.

Being tested
Ciprofol, Propofol
Keywords
Ciprofol, Gastroenterological Endoscope, Overweight, Obesity
Medical subject headings
Stomach Ulcer, Stomach Neoplasms, Overweight, Obesity

What participants receive

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

  • CiprofolDrug

    The sedation of gastrointestinal endoscopy with Ciprofol

  • PropofolDrug

    The sedation of gastrointestinal endoscopy with Propofol

Study groups in NCT05518929
Study groupRoleWhat they receive
Control group(Propofol group)Active comparatorAnesthesia induction:Propofol 1.5mg/kg Anesthesia maintenance: Propofol 0.75mg/kg
Receives: Drug: Propofol
Experimental group(ciprofol group)ExperimentalAnesthesia induction:ciprofol 0.4mg/kg Anesthesia maintenance: ciprofol 0.2mg/kg
Receives: Drug: Ciprofol

What is being measured

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

  1. Incidence of hypoxia and severe hypoxia

    hypoxia( 75%≤SpO2≤89% for<60s);severe hypoxia(SpO2<75%，or SpO2<90% for >60s)

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary outcomes (6)

  1. Incidence of hypoxia

    hypoxia( 75%≤SpO2≤89% for<60s)

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  2. Incidence of severe hypoxia

    severe hypoxemia(SpO2<75%，or SpO2<90% for >60s)

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  3. Incidence of subclinical respiratory depression

    subclinical respiratory depression（90% ≤SpO2 ≤95% ）

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  4. Success rate of gastroenteroscopy endoscope

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  5. Incidence of injection pain when the intravenous administration of Ciprofol or propofol for sedation assessed by questionnaire.

    Patients complain pain at the site of injection or tell investigators feeling pain when they were asked before they lose consciousness.

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

  6. Proportion of corrective hypoxic measures

    Treatment of patients with hypoxia

    Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Timeline

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

  1. First posted29 Aug 2022
  2. Study start8 Sep 2022
  3. Primary completion15 Aug 2023
  4. Study completion30 Aug 2023

Resources

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
Model description
Multicenter, Randomized, Open-label, Propofol-controlled
Masking
None (open label)
Enrolment
1,090 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05518929
Sponsor's protocol ID
KY2022-155-B
Acronym
SpO2
Status last verified
Jun 2024
First submitted
24 Aug 2022
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou R, Dai W, Su Z, Lian Y, Wen P, Zhang L, Kong L, Hua Z, Sun Y, Zhao H, Wang Q, Yu W, Su D. Ciprofol Versus Propofol for the Prevention of Hypoxia During Gastrointestinal Endoscopy Procedures in Overweight Patients: A Multicenter, Randomized, Controlled Trial. Dig Endosc. 2026 Feb;38(2):e70102. doi: 10.1111/den.70102.

    PubMed 41626789

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciprofol and Propofol in people with Gastric Ulcer and Gastric Cancer, run by RenJi Hospital at 5 sites 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 6 inclusion and 15 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 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. 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?

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?

Incidence of hypoxia and severe hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours). 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 NCT05518929, 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 7 Jun 2024.

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