Gastric CancerNCT05517408
Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
A study testing ciprofol in people with Gastric Cancer and Gastric Ulcer, run by RenJi Hospital at 1 site in China.
Trial summary
Ciprofol is a new anesthetic, which combines 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 60 years
- Conditions the study is for
- Gastric Cancer, Gastric Ulcer, Intestinal Polyps
- What is being tested?
- ciprofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2022to 13 Aug 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age, ≤18 and ≤60 years, no gender limit
- Undergoing routine gastrointestinal endoscopic diagnosis and treatment
- American Society of Anesthesiologists (ASA) classification I-II
- Body Mass Index(BMI) ≥28kg/m^2
- Clearly understand and voluntarily participate in the study; provide signed informed consent
Who cannot join
- Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
- Drug abuse history within 3 months before the screening period
- People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc
- The researcher believes that patients should not participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200000
diansan su, PhD, 18616514088, diansansu@yahoo.com
About this study
Ciprofol is a new anesthetic, which combines 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 sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.
- Conditions
- Gastric Cancer, Gastric Ulcer, Intestinal Polyps, Intestinal Cancer
- Being tested
- ciprofol
- Keywords
- sedation, gastrointestinal endoscopy, obese patient, ciprofol
- Medical subject headings
- Stomach Neoplasms, Stomach Ulcer, Intestinal Polyps, Intestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
The first patient received Ciprofol 0.3mg/kg (actual body weight) at a rate of 1 mg/s. If the desired depth of sedation/anesthesia reached, then it was judged as negative, and the dose of Ciprofol in next patient would be decreased by one concentration gradient (the difference between two adjacent drugs was 1:1.1); If the desired sedation/anesthesia depth was not achieved, then it was judged as positive. And the dose of Ciprofol in next patient would be increased by one concentration gradient. Patients were enrolled consecutively until the trial was terminated at the eighth crossing point (positive to negative or negative to positive).
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol group | Experimental | Not described Receives: Drug: ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.
Measured: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes (1)
Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.
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.
- First posted26 Aug 2022
- Study start19 Sep 2022
- Primary completion3 Nov 2022
- Study completion13 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517408
- Sponsor's protocol ID
- diansansu0722
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.
- ClinicalTrials.gov ID
- NCT05517408
- Acronym / sponsor ID
- diansansu0722
- Conditions
- Gastric Cancer, Gastric Ulcer, Intestinal Polyps, Intestinal Cancer
- Keywords
- sedation, gastrointestinal endoscopy, obese patient, ciprofol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 13 Aug 2023 (estimated)
- First posted
- 26 Aug 2022 (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.
Ciprofol is a new anesthetic, which combines 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 sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciprofol group | Experimental | Drug: ciprofol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age, ≤18 and ≤60 years, no gender limit
- Undergoing routine gastrointestinal endoscopic diagnosis and treatment
- American Society of Anesthesiologists (ASA) classification I-II
- Body Mass Index(BMI) ≥28kg/m^2
- Clearly understand and voluntarily participate in the study; provide signed informed consent
Key exclusion criteria (4 listed)
- Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
- Drug abuse history within 3 months before the screening period
- People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc
- The researcher believes that patients should not participate in this trial
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 |
|---|---|---|
| ciprofolThe first patient received Ciprofol 0.3mg/kg (actual body weight) at a rate of 1 mg/s. If the desired depth of sedation/anesthesia reached, then it was judged as negative, and the dose of Ciprofol in next patient would be decreased by one concentration gradient (the difference between two adjacent drugs was 1:1.1); If the desired sedation/anesthesia depth was not achieved, then it was judged as positive. And the dose of Ciprofol in next patient would be increased by one concentration gradient. Patients were enrolled consecutively until the trial was terminated at the eighth crossing point (positive to negative or negative to positive). | Drug | Ciprofol group |
Primary outcome
Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
1 secondary outcome
Calculating the the ED95 of ciprofol for sedation gastrointestinal endoscopy in obese patients.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No. We have no plan to share individual participant data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofol in people with Gastric Cancer and Gastric Ulcer, run by RenJi Hospital 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact diansan su, PhD (18616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculating the the median effective dose (ED50) of ciprofol for sedation gastrointestinal endoscopy in obese patients. (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?
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 16 Aug 2023.